The impact of an oral nutritional supplement on body weight gain in older adults with malnutrition: an open-label randomized controlled trial.

BACKGROUND: The global aging population is expanding rapidly and many individuals have a particularly higher risk of malnutrition. Malnutrition can lead to impaired body function, morbidity, and mortality. Meeting nutritional requirements is a key strategy to minimize multiple debilitating adverse outcomes associated with malnutrition in the elderly. Oral nutritional supplements (ONS) have been widely used as a dietary intervention for malnutrition in older adults. These supplements provide additional nutrients and calories to support nutritional requirements and have been shown to improve nutritional status, physical function, and quality of life in malnourished older adults. METHODS: This is an open-label, randomized controlled, parallel-group study including 50 institutionalized older adults (aged > 60 years) with malnutrition or at risk of malnutrition, living in a selected elderly care institution in Colombo, Sri Lanka. The aim is to assess improvement in healthy body weight gain and body composition in older adults with malnutrition at risk of malnutrition by using an ONS. Older adults will be screened for malnutrition using the Mini Nutrition Assessment (MNA) tool and eligible participants randomized using the simple random sampling technique to intervention and control groups (1:1 allocation ratio). The intervention group will consume 200 mL of ONS before bed continuously for 12 weeks. The primary outcome is the percentage who achieved at least 5% weight gain in the intervention group compared to the control group. Nutritional status (anthropometric, biochemical, clinical, and dietary), body composition (dual-energy X-ray absorptiometry), frailty, functional capacity (hand grip strength, knee extension, and Barthel index) cognitive status (Montreal Cognitive Assessment), and physical activity will be assessed as secondary outcomes at baseline and at the end of the 12-week intervention. Some measurements (anthropometry, dietary, and functional assessments) will also be performed at the end of the 4th week. Data will be analyzed using SPSS V-23. DISCUSSION: This study will determine whether the use of an ONS is effective in promoting healthy weight gain in older adults with malnutrition or at risk of malnutrition. In addition, investigating the impact of an ONS on multiple outcomes via clinical, nutritional, functional, and cognitive function will provide a more comprehensive understanding of the potential benefits of these supplements. TRIAL REGISTRATION: Sri Lanka Clinical Trail Registry SLCTR/2022/021. Oct. 6, 2022.

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial.

AIMS: The burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults. METHODS: We conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4%, 39-46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse. RESULTS: The baseline-adjusted mean group difference at 6 months, expressed as treatment-placebo, (95% CI) was -0.02 (-0.14, 0.11, p = 0.78) for HbA1c and 0.17 (-0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%). CONCLUSION: We believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.

Zinc supplementation in prediabetes mellitus.

INTRODUCTION: Certain pharmacological and lifestyle interventions have been shown to reduce progression of prediabetes. We aimed to perform a systematic review and meta-analyses of studies assessing the outcomes of zinc supplementation in individuals with prediabetes. EVIDENCE ACQUISITION: A comprehensive search was conducted in PubMed, SciVerse Scopus and Web of Science databases. Controlled clinical trials in prediabetics individuals, on zinc supplementation with or without other nutrients, assessing at least one accepted glycemic parameter as an outcome were deemed eligible. EVIDENCE SYNTHESIS: Three papers were included in the systematic review and meta-analysis, with a total of 265 participants. Duration of zinc supplementation ranged from 6-12 months. The zinc dose ranged from 20-30 mg/day. In the pooled analysis, zinc supplementation significantly reduced FBG both when given alone (-10.86 mg/dL; 95% CI, -14.74 to -6.98; P<0.001) and with other micronutrients (-11.77 mg/dL; P<0.001). Similarly, 2hr-OGTT blood glucose was reduced by 21.08 mg/dL (95% CI, -40.05 to -2.11; P=0.03) in the pooled analysis of studies using zinc alone and in combination with other micronutrients. One study demonstrated a significant reduction of HbA1c by 0.5% with combined supplementation, while another reported a significant reduction in CRP with zinc supplementation. When all trials were considered, TC, HDL-c and HOMA-ß showed significant improvement. Zinc supplementation significantly improved the zinc status from baseline. CONCLUSIONS: Zinc supplementation demonstrated beneficial effects on glycemic and lipid parameters in individuals with prediabetes. It may have the potential to reduce the prevalence of prediabetes and control associated morbidity and mortality.

The use of Caralluma fimbriata as an appetite suppressant and weight loss supplement: a systematic review and meta-analysis of clinical trials.

BACKGROUND: Obesity prevalence has increased during the past few decades, causing a pandemic with an influx in other co-morbidities. Many factors influence weight gain in an obesogenic environment therefore strategies for treating obesity may vary from conventional dietary and physical activity interventions to pharamacotherapy. A shift in unconventional strategies as herbal products for treating obesity have been investigated and one such plant extract is Caralluma fimbriata (C. fimbriata). Further, the studies included were systematically reviewed to gather evidence on potential effects of C. fimbriata as an appetite suppressant and weight loss supplement. METHODS: A systematic review of clinical trials reporting the effects of C. fimbriata as appetite suppression and anti-obesity supplement was reported according to PRISMA guidelines. Data were obtained by searching three databases: PubMed®, Web of Science® and SciVerse Scopus® for studies published until 30th April 2020. RESULTS: A total of 7 articles studying C. fimbriata satisfied the inclusion and exclusion criteria and were sourced from various countries including Australia (3), Cuba (1), India (2) and Spain (1). Almost all studies recruited adults who were overweight or obese with a BMI > 25 kg/m2 (n = 5), with the exception of two studies, one that recruited healthy adults with a BMI average of 26.5 kg/m2 and the second one utilised a population of children and adolescents with Prader-Willis Syndrome (PWS). Parameters assessing obesity, biochemical and appetite factors were analysed by carrying out a meta-analysis. Compared to placebo controlled group, C. fimbriata extract significantly reduced WC by 1.59 cm (95% CI, - 3.07 to - 0.10, p = 0.041) and WHR by 0.06 (95% CI, - 0.12 to - 0.01, p = 0.05) although no significant effects were seen on BW, BMI and HC. Biochemical and appetite parameters outcome on C. fimbriata consumption had no significant changes. Any side effects of individuals who ingested the extract were reported by few studies of which most common effects were constipation, diarrhoea, nausea and rashes. CONCLUSION: Appetite parameters showed no significant changes and metabolic parameters did not improve with C.fimbriata supplementation therefore it is unlikely to recommend C. fimbriata as a weight loss supplement and an appetite suppressant.

Effects of the Lysulin™ supplementation on pre-diabetes: A randomized double-blind, placebo-controlled clinical trial.

BACKGROUND AND AIMS: Diabetes is a leading cause of morbidity and mortality worldwide. Recent studies have demonstrated that nutraceutical products have beneficial effects in diabetes. Present study aims to investigate whether a product (Lysulin™) containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects in pre-diabetes. METHODS: A randomized, double-blind, placebo-controlled trial was conducted for a period of 6 months. The two parallel groups (1:1) were Lysulin™ (Interventional group-IG) and placebo (control group-CG). Evaluations were done at baseline, 1, 3 and 6 months. Primary outcome was defined as change in glycaemic control measured by HbA1c from baseline. Other outcomes included change in; fasting plasma glucose (FPG), 2-h OGTT plasma glucose and lipid profile from baseline. Three multiple regression analyses were performed, where change in FPG, 2-h OGTT, and HbA1c post intervention from baseline respectively were the continuous dependent variable with other independent variables. RESULTS: One hundred and ten participants were recruited, 50% (n = 55) were males and mean age (±SD) was 46.7 ± 9.9 years. A significantly higher percentage of participants in CG (25.4%, n = 14) developed diabetes in comparison to IG (7.3%, n = 4) (p = 0.018). FPG, 2-h OGTT and HbA1c significantly reduced in the IG only. Both total cholesterol and LDL cholesterol decreased significantly from baseline only in the IG. In all three regression models the best predictor of respective dependent variable was Lysulin™ treatment. CONCLUSIONS: Lysulin™ improved glycaemic control, with reduced progression to diabetes, in those with pre-diabetes. Treatment also showed a beneficial reduction in total and LDL cholesterol levels. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry, identifier: SLCTR/2018/022 (http://slctr.lk/trials/1290). Registered on 13th July 2018; Study protocol version 2.0 (23rd March 2018).

Exploring the Therapeutic Benefits of Pranayama (Yogic Breathing): A Systematic Review.

BACKGROUND: Pranayama (yogic breathing) has demonstrated numerous beneficial health effects. At present, there are no systematic reviews evaluating the beneficial health effects of pranayama alone as a practice. AIM: The aim of this study is to perform a systematic review about the beneficial health effects of pranayama. METHODS: Data were obtained using a stepwise search process by searching the online PubMed, Web of Science, and SciVerse Scopus databases using keywords. Controlled clinical trials in humans, using "Pranayama" as an intervention with an appropriate control group and evaluating health-related outcomes were selected for inclusion. RESULTS: Initial database searching indicated 669 potentially eligible articles, of which 18 studies satisfying the inclusion/exclusion criteria were selected. All were controlled trials, of which 13 were randomized and 1 was a crossover study. Number of participants ranged from 16 to 160, and the duration of pranayama practice varied from 4 days to 6 months. Studies demonstrated a significant effect on cardiorespiratory functions, in patients with bronchial asthma, with the improvement of pulse rate, systolic blood pressure, and respiratory function measurements. Furthermore, reduction in the frequency of attacks, severity, and medication requirement was also observed, with improved quality of life (QOL). In patients with chronic obstructive pulmonary disease, symptom, activity, and impact scores were improved. QOL improvement was also noted in cancer patients. CONCLUSIONS: Available evidence on pranayama indicates physiological and psychological benefits. Beneficial effects were mostly observed in patients with respiratory diseases such as bronchial asthma. It also helped those with cancer and cardiovascular disease. However, further high-quality randomized trials are required to provide definitive evidence.

Enhancing immunity in viral infections, with special emphasis on COVID-19: A review.

BACKGROUND AND AIMS: Balanced nutrition which can help in maintaining immunity is essential for prevention and management of viral infections. While data regarding nutrition in coronavirus infection (COVID-19) are not available, in this review, we aimed to evaluate evidence from previous clinical trials that studied nutrition-based interventions for viral diseases (with special emphasis on respiratory infections), and summarise our observations. METHODS: A systematic search strategy was employed using keywords to search the literature in 3 key medical databases: PubMed®, Web of Science® and SciVerse Scopus®. Studies were considered eligible if they were controlled trials in humans, measuring immunological parameters, on viral and respiratory infections. Clinical trials on vitamins, minerals, nutraceuticals and probiotics were included. RESULTS: A total of 640 records were identified initially and 22 studies were included from other sources. After excluding duplicates and articles that did not meet the inclusion criteria, 43 studies were obtained (vitamins: 13; minerals: 8; nutraceuticals: 18 and probiotics: 4). Among vitamins, A and D showed a potential benefit, especially in deficient populations. Among trace elements, selenium and zinc have also shown favourable immune-modulatory effects in viral respiratory infections. Several nutraceuticals and probiotics may also have some role in enhancing immune functions. Micronutrients may be beneficial in nutritionally depleted elderly population. CONCLUSIONS: We summaries possible benefits of some vitamins, trace elements, nutraceuticals and probiotics in viral infections. Nutrition principles based on these data could be useful in possible prevention and management of COVID-19.

Availability and composition of weight-loss supplements in Sri Lanka.

AIM: The present study aims to investigate the composition and availability of weight-loss supplements in Sri Lanka and explore the evidence for their effectiveness. METHODS: Data were collected by visiting drug stores, searching the Internet for websites and referring to advertisements in national newspapers and magazines from August to October 2017. RESULTS: A total of 100 weight-loss products were identified of which the majority (n = 57) were available from drug stores. Most commonly, products were available in capsule form (36.0%). The number of active ingredients in products varied from 1 to a maximum of 22 with a total of 155 different active ingredients distinguished. The ingredients mainly originated from plants (77.4%) while green tea (Camellia sinensis), garcinia (Garcinia cambogia) and caffeine anhydrous were the three most common. At least one of the top 10 ingredients was included in 75 of the products sourced. Directions for use were specified in only 72 products, while a further 6 products lacked any information on ingredients. Literature predicted positive weight-loss effects for green tea and ginger while garcinia was reported for both positive and negative effects. CONCLUSIONS: The ingredients are reported to have both beneficial and adverse effects. Many consumers may find it challenging to make informed purchase decisions as a number of products failed to provide adequate nutritional information and safety measures. Government regulatory authorities should pay closer attention to the availability and provision of products sold to the general public.

Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD Study) - study protocol for a randomised placebo-controlled trial in Australia.

BACKGROUND: Diabetes is increasing in incidence, morbidity and treatment costs globally, hence prevention strategies need to be explored. Animal studies and some human data have shown that zinc can improve glycaemic control, but the impact of this effect in a pre-diabetic population remains uncertain. This study is designed to investigate whether zinc gluconate and lifestyle coaching can improve glucose handling and ultimately reduce diabetes incidence in an at-risk pre-diabetic population in Australia. METHODS/DESIGN: The study will be a randomised, placebo-controlled, double-blind clinical trial. The study will be conducted at the Hunter New England Local Health District New South Wales (NSW), Australia. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4) male and female participants (n = 410) aged 40-70 years will be recruited through the Diabetes Alliance Network, a collaboration of diabetes specialists and general practitioner practices. All participants will be given routine care to encourage healthy lifestyle changes using a telephone coaching service (Get Healthy Information and Coaching Service, NSW Health) and then randomised to receive a supplement, either zinc gluconate (equivalent to 30 mg of elemental zinc) or placebo of identical appearance for 12 months. The identity of the supplements will be blinded to both research personnel and the participants. Participants will be asked to complete medical, lifestyle and dietary surveys and will have baseline and final visits at their general practitioner practice. Primary outcomes will be HbA1c and insulin sensitivity collected at baseline and at 1, 6 and 12 months; secondary outcomes will include fasting blood glucose, fasting cholesterol, blood pressure and body mass index. The primary efficacy endpoint will be judged at 6 months. DISCUSSION: This study will generate new evidence about the potential for health coaching, with or without zinc supplementation, to improve glucose handling and ultimately to reduce progression from pre-diabetes to diabetes. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268 . Registered on 6 July 2018.

Effects of Lysulin™ supplementation on pre-diabetes: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes mellitus is rapidly becoming one of the leading causes of morbidity and mortality worldwide. Preventive measures have become important, especially in the South Asian region and other parts of the world where diabetes is becoming increasingly prevalent. We postulate that a product containing amino acid lysine, micronutrient zinc and vitamin C will have beneficial effects on glycemic control and disease progression in patients with pre-diabetes and we aim to evaluate this hypothesis using a phase II/III randomized double-blind controlled clinical trial design. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 6 months. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo, Sri Lanka. A total of 110 adults with pre-diabetes will be recruited for the study. They will be randomly assigned to the test and placebo groups on a 1:1 ratio. The test group will receive two tablets of Lysulin™ three times a day and the control group will receive identical placebo tablets. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 months (visit 2) and 6 months (visit 4). The primary outcome will be defined as change in glycemic control measured by HbA1c from baseline. Data will be analyzed using SPSS v16. DISCUSSION: To our knowledge this is one of the first randomized controlled trials evaluating the effects of Lysulin™ (a combination of lysine, vitamin C and zinc) in pre-diabetes. This study will provide the necessary groundwork for future large-scale multicentered clinical trials. The result, positive or negative, should provide a step change in the evidence guiding current and future policies regarding management of pre-diabetes. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry, SLCTR/2018/022 . Registered on 13 July 2018. Study protocol version 2.0 (23 March 2018).

The benefits of yoga practice compared to physical exercise in the management of type 2 Diabetes Mellitus: A systematic review and meta-analysis.

Yoga is increasingly used as an adjunctive therapy in the management of Type-2 Diabetes Mellitus (T2DM). The present study aims to systematically evaluate the literature and perform a meta-analysis on the effects of yoga practice compared to physical exercise in the management of T2DM. Data were obtained using a stepwise search process using keywords in the following online medical databases; PubMed, Web of Science and Scopus. All controlled clinical trials involving patients with T2DM, comparing yoga as an intervention with physical exercise and evaluating glycaemic control and other outcomes between the intervention and control groups were included in the analysis. Eight studies were eligible to be included in the systematic review. In total, 842 participants were assigned to a Yoga intervention or a control group with an Exercise intervention and the age range of participants was 30-78 years. A significant reduction in FBG (15.16 mg/dl), PPBG (28.66 mg/dl), HbA1c (0.39%) and BMI (0.71 kg/m2) was noted in the intervention group ('Yoga') compared to the control group ('Physical Exercise') in the pooled analysis. We did not observe any significant difference between the two groups for lipid parameters, other body composition measures (WC and WHR) and Blood Pressure. In conclusion, our results show that Yoga has beneficial effects on glycaemic control in comparison to physical exercise in T2DM However, individual studies showed considerable heterogeneity. Hence, further well-controlled randomized trials are required prior to drawing conclusions about the benefits of yoga in comparison to physical exercise.

Zinc supplementation in prediabetes: A randomized double-blind placebo-controlled clinical trial.

BACKGROUND: This study evaluated the effects of zinc supplementation on glycemic control, other cardiometabolic and anthropometric parameters, and disease progression in prediabetes. METHODS: A randomized double-blind placebo-controlled Phase 2 clinical trial was conducted over a 12-month period in 200 subjects (43% male; mean [± SD] age 51.8 ± 7.3 years), randomly assigned (1: 1) to the treatment or control group. The treatment group received zinc (20 mg daily). Subjects were evaluated at baseline and at 1, 3, 6, and 12 months. The primary outcome was the change in glycemic control from baseline. Multiple regression analyses were performed, with change in outcome variables after intervention from baseline used as continuous dependent variables. RESULTS: In both groups, mean serum zinc concentrations prior to the trial were below normal (15.29-21.41 µmol/L). During the 12-month follow-up, a significantly higher percentage of participants developed type 2 diabetes in the control compared with zinc-treated group (25.0% vs 11.0% respectively; P = 0.016). Fasting plasma glucose (FPG), 2-h glucose levels in the oral glucose tolerance test (OGTT), homeostasis model assessment of insulin resistance (HOMA-IR), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) were significantly lower in the treated group, with significant improvement in ß-cell function. In all four regression models, the best predictor of the dependent variables (i.e. change in FPG, 2-h glucose in the OGTT, HOMA-IR, and homeostatic model assessment of ß-cell function) was zinc treatment. CONCLUSIONS: Zinc supplementation reduced blood glucose and insulin resistance while improving ß-cell function. Furthermore, supplementation reduced disease progression to diabetes and had beneficial effects on TC and LDL-C.

Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial.

BACKGROUND: Cinnamon is considered as a treatment for many ailments in native medicine. Evidence suggests that Cinnamomum zeylanicum (CZ) has anti-microbial, anti-parasitic, anti-oxidant, blood glucose lowering properties and beneficial cardiovascular effects. The present study aims to evaluate Pharmacodynamic properties and safety of CZ in healthy adults using a Phase I Clinical Trial. METHODS: This phase I clinical trial was conducted at the Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka. Thirty healthy adults were recruited for the study, conducted for a period of 3 months, with the dose of CZ (water extract) increased at monthly intervals (85 mg, 250 mg and 500 mg). Data collection was carried out at baseline and during each monthly follow up visit. Anthropometric, clinical and biochemical assessments were done at baseline and during follow up. Adverse effects and drug compliance was also evaluated. RESULTS: Twenty eight subjects completed the three months follow up. Mean age was 38.8 ± 10.4 years and 50% were males. There were no significant changes in the anthropometric parameters during the three months follow up. Both systolic and diastolic blood pressure reduced significant during the 1st month and this reduction was sustained throughout follow up. Full blood count, renal function tests, liver function tests, fasting blood glucose, HDL-c, VLDL-d and triglycerides remained within the normal range without any significant alteration during the 3 months. A significant reduction in the TC (p < 0.05) and LDL-c (p < 0.001) was noted at the end of the 3 months follow up period. There were no serious adverse effects (including hypersensitivity) noted. In two participants dyspepsia necessitated the discontinuation of study participation. Drug compliance was between 85 and 95% during the study period. CONCLUSIONS: This is the first phase I clinical trial in health adults evaluating efficacy and safety of CZ. Our results demonstrate no significant side effects and toxicity of CZ, including hepatotoxicity and anti-coagulation properties. CZ demonstrated beneficial anti-hyperlipidaemic and blood pressure lowering effects among healthy adults. Further studies with larger samples and longer durations may be able to elucidate other side effects and better describe the pharmacodynamic properties. TRIAL REGISTRATION: SLCTR/2013/001 (Sri Lanka Clinical Trials Registry: http://www.slctr.lk/trials/106 ) (Date of Registration: 01/01/2013).

Cinnamomum zeylanicum (Ceylon cinnamon) as a potential pharmaceutical agent for type-2 diabetes mellitus: study protocol for a randomized controlled trial.

BACKGROUND: Previous studies have explored the anti-diabetic effects of Cinnamomum cassia extract in vivo and in vitro. However, there are no studies at present exploring the effects of the indigenous species of Sri Lankan cinnamon (Cinnamomum zeylanicum) in patients with diabetes mellitus. The present study aims to evaluate the potential effects of Cinnamomum zeylanicum extract as a pharmaceutical agent in patients with type-2 diabetes mellitus. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 4 months at the Medical Clinic, University Medical Unit, National Hospital of Sri Lanka. A total of 210 subjects with diabetes, in three equal groups, will be recruited for the study. The patients will be randomized in a 1:1:1 ratio according to the method of block randomization and the subjects will be randomly and equally assigned into two test groups (n = 70 each) and one placebo group (n = 70). The population will be stratified at randomization based on age, gender and disease severity. The treatment drug is a capsule containing Cinnamomum zeylanicum extract as the active ingredient and the placebo capsule will contain lactose monohydrate. Two doses of Cinnamomum zeylanicum extracts (250 mg and 500 mg of the cinnamon extract) will be used. The study drugs will be double blinded to both investigators and participants. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 2 months (visit 2), 3 months (visit 3) and 4 months (visit 4). The following primary outcome measures will be evaluated: glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG) and serum insulin. Secondary outcome measures include: Body Mass Index (BMI) and other anthropometric parameters, blood pressure, total cholesterol, low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL) and triglycerides (TAG). Data will be analyzed using SPSS version 14. DISCUSSION: We describe the protocol for a clinical trial design evaluating the effects of Cinnamomum zeylanicum (Ceylon cinnamon) in patients with type-2 diabetes mellitus. The result of the present study, positive or negative, should provide a step change in the evidence guiding current and future policies regarding the use of cinnamon dietary supplementation in patients with diabetes. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry (SLCTR), identifier: SLCTR/2017/010 ( http://slctr.lk/trials/714 ). Registered on 5 April 2017; study protocol version 3.1 21 March 2017.

Interventions for treatment and/or prevention of alcohol hangover: Systematic review.

OBJECTIVE: To evaluate new research conducted over the past few years (2009-2016) assessing the effectiveness of potentially curative and/or preventive methods of alcohol hangover. METHODS: Data were retrieved by a 4-stage systematic search process. A search of the online Pubmed and Scopus databases were performed, using a combination of keywords: "Alcohol," "Ethanol," and "C2 H5 OH," in combination with the terms "Hangover," "Treatment," and "Prevention." The search comprised studies listed between January 1, 2009 and June 30, 2016. Findings were synthesized using a systematic approach. Quantitative analysis was not done because of the heterogeneity of the included studies. RESULTS: Six controlled human studies were identified (placebo controlled-3, controlled studies with a comparator intervention-3). Of the interventions, the use of polysaccharide rich extract of Acanthopanax senticosus, red ginseng antihangover drink, Korean pear juice, KSS formula, and the After-Effect© were associated with a significant improvement of hangover symptoms (p < .05). The highest improvement was observed for the following symptoms: tiredness, nausea/vomiting, and stomachache. None of the methods were effective for all the symptoms. CONCLUSION: The available evidence suggests that several products are capable of significantly improving some, but not all, of the symptoms related to alcohol hangover. Therefore, further research is necessary to develop clinically effective hangover treatments.

Effects of Zinc supplementation on serum lipids: a systematic review and meta-analysis.

Zinc is a mineral that plays a vital role in many biological processes and plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Numerous studies have evaluated the effects of Zinc supplementation on serum lipids in humans and have demonstrated varying results. We systematically evaluated the literature and performed a meta-analysis on the effects of Zinc supplementation on serum lipids. A five staged comprehensive search of the literature was conducted in the following databases; PubMed, Web of Science and SciVerse Scopus for studies published before 31st December 2014. All controlled clinical trial in humans, that included a Zinc supplement intervention, either alone or in combination with other micronutrients and evaluated effects on serum lipids (total cholesterol [TC], triglycerides [TG], LDL cholesterol [LDL-c] and HDL cholesterol [HDL-c]). A meta-analysis of selected studies was performed using RevMan v5.3. The Jaded scale was used to assess the methodological quality of the trials included in the systematic review. A total of 24 studies were included in Meta analysis, which included a total of 33 Zinc interventions, in a total of 14,515 participants in the Zinc intervention or control group. The duration of Zinc supplementation ranged from 1 month to 7.5 years. The dose of elemental Zinc supplemented ranged from 15-240 mg/day. The pooled mean difference for TC between Zinc supplemented and placebo groups from random effects analysis was -10.92 mg/dl (95 % CI: -15.33, -6.52; p < 0.0001, I(2) = 83 %), while for HDL cholesterol it was 2.12 mg/dl (95 % CI: -0.74, 4.98; p = 0.15, I(2) = 83 %). The pooled mean difference for LDL-c between Zinc supplemented and placebo group from random effect analysis was -6.87 mg/dl (95 % CI: -11.16,-2.58; p < 0.001, I(2) = 31) and for TG it was -10.92 mg/dl (95 % CI: -18.56, - 3.28; p < 0.01, I(2) = 69 %). In conclusion, Zinc supplementation has favourable effects on plasma lipid parameters. Zinc supplementation significantly reduced total cholesterol, LDL cholesterol and triglycerides. Therefore it may have the potential to reduce the incidence of atherosclerosis related morbidity and mortality.

Medicinal properties of 'true' cinnamon (Cinnamomum zeylanicum): a systematic review.

BACKGROUND: In traditional medicine Cinnamon is considered a remedy for respiratory, digestive and gynaecological ailments. In-vitro and in-vivo studies from different parts of the world have demonstrated numerous beneficial medicinal effects of Cinnamomum zeylanicum (CZ). This paper aims to systematically review the scientific literature and provide a comprehensive summary on the potential medicinal benefits of CZ. METHODS: A comprehensive systematic review was conducted in the following databases; PubMed, Web of Science, SciVerse Scopus for studies published before 31st December 2012. The following keywords were used: "Cinnamomum zeylanicum", "Ceylon cinnamon", "True cinnamon" and "Sri Lankan cinnamon". To obtain additional data a manual search was performed using the reference lists of included articles. RESULTS: The literature search identified the following number of articles in the respective databases; PubMed=54, Web of Science=76 and SciVerse Scopus=591. Thirteen additional articles were identified by searching reference lists. After removing duplicates the total number of articles included in the present review is 70. The beneficial health effects of CZ identified were; a) anti-microbial and anti-parasitic activity, b) lowering of blood glucose, blood pressure and serum cholesterol, c) anti-oxidant and free-radical scavenging properties, d) inhibition of tau aggregation and filament formation (hallmarks of Alzheimer's disease), e) inhibitory effects on osteoclastogenesis, f) anti-secretagogue and anti-gastric ulcer effects, g) anti-nociceptive and anti-inflammatory activity, h) wound healing properties and i) hepato-protective effects. The studies reported minimal toxic and adverse effects. CONCLUSIONS: The available in-vitro and in-vivo evidence suggests that CZ has many beneficial health effects. However, since data on humans are sparse, randomized controlled trials in humans will be necessary to determine whether these effects have public health implications.

Zinc supplementation in pre-diabetes: study protocol for a randomized controlled trial.

BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.