ABSTRACT
With a constantly growing elderly population, incidences of neurodegenerative diseases are also rising and are expected to further increase over the next years, while costing health systems across the world trillions of dollars. Therefore, biomarkers to detect manifestations of brain aging early and interventions to slow down its pace are of great interest. In the last years, the importance of the neurotrophins brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) in the context of cognitive function and the aging brain has increased, besides the already well-established amyloid-beta (Aß) and tau plaques. Due to their wide range of beneficial health effects as well as their antioxidant and anti-inflammatory properties, a class of secondary plant-metabolites, the so-called polyphenols, gained increasing attention. In this review, we discuss the roles of BDNF, Aß, NGF, and tau proteins as biomarkers of brain aging and the effect of dietary polyphenol interventions on these biomarkers, assessed via blood analysis, magnetic resonance imaging (MRI), and positron emission tomography (PET).
Subject(s)
Brain-Derived Neurotrophic Factor , Nerve Growth Factor , Middle Aged , Humans , Aged , Brain/diagnostic imaging , Aging , Amyloid beta-Peptides , BiomarkersABSTRACT
BACKGROUND: Ageing is a process characterised by chronic low-grade inflammation and oxidative stress which could lead to increased prevalence of both physical and mental age-related chronic conditions. A healthy balanced diet, rich in fruit and vegetables as well as omega-3 polyunsaturated fatty acids (n3 PUFA), could reduce oxidative stress and improve markers of low-grade inflammation. Nonetheless, considering that a large part of the population struggles to meet current guidelines on fruit and vegetable and n3 PUFA recommendations, fruit and vegetable concentrate supplements and mixed omega fatty acid supplements could be an effective strategy to bridge the gap between actual and recommended intakes. METHODS: In this randomised, controlled, open-labelled, parallel-grouped clinical trial, 112 participants will be allocated to one of four arms (n = 28 on each arm): an encapsulated juice powder concentrate, a plant-based omega fatty acid supplement, both or a control group. We aim to investigate whether long-term separate or combined ingestion of the two can affect biomarkers of cardiovascular health, low-grade inflammation and indicators of ageing, including cognitive function, in middle-aged and elderly people. We will additionally explore the effect of the different supplementations on plasma levels of vitamins, carotenoids and fatty acids. Intervention will last 2 years and participants will be assessed at baseline and at follow-up visits at 6, 12, 18 and 24 months. DISCUSSION: This study will provide evidence whether long-term, plant-based dietary supplementation can support cardiovascular health, anti-inflammatory processes, immunity and nutritional status in ageing. Trial registration This trial was registered at ClinicalTrials.gov (NCT04763291) on February 21, 2021.
Subject(s)
Dietary Supplements , Fatty Acids, Omega-3 , Aged , Middle Aged , Humans , Inflammation/prevention & control , Vegetables , Fatty Acids , Fatty Acids, Omega-3/therapeutic use , Randomized Controlled Trials as TopicABSTRACT
The incidence of thrombosis increases with aging. We investigated the coagulatory/haemostatic system across the ages and tested the hypothesis that older persons have a hypercoagulable state compared to younger persons at rest, and that standing up (orthostasis) leads to greater changes in coagulation in older persons. In total, 22 older and 20 young participants performed a 6 min sit-to-stand test (orthostatic challenge). Blood was collected prior to and at the end of standing and haemostatic profiling was performed via thrombelastometry (TEM), calibrated automated thrombogram (CAT) and standard coagulation assays. At baseline, three CAT-derived values indicated enhanced capability to generate thrombin in older participants. However, other measured parameters did not suggest a hypercoagulable state in older participants: prolonged TEM-derived coagulation times (295 vs. 209 s, medians, p = 0.0025) and prothrombin times (103 vs. 114%, medians, p = 0.0087), as well as lower TF levels (440 vs. 672 pg/mL, medians, p = 0.0245) and higher t-PA levels (7.3 vs. 3.8 ng/mL, medians, p = 0.0002), indicative of enhanced fibrinolytic capability, were seen. Younger participants were more sensitive to the orthostatic challenge: CAT-derived endogenous thrombin potentials (ETPs) were only increased in the young (1337 to 1350 nM.min, medians, p = 0.0264) and shortening of PTs was significantly higher in the young vs. older participants (p = 0.0242). Our data suggest that the increased thrombosis propensity in older persons is not primarily attributable to a hyperactive coagulation cascade but may be due to other pathologies associated with aging.
ABSTRACT
Nitric oxide donors (NO-donors) have been shown to have therapeutic potential (e.g., ischemia/reperfusion injury). However, due to their release rate/antiplatelet properties, they may cause bleeding in patients. We therefore studied the antiplatelet effects of the two different NO-donors, i.e., S-NO-Human Serum Albumin (S-NO-HSA) and Diethylammonium (Z)-1-(N,N-diethylamino)diazen-1-ium-1,2-diolate (DEA-NONOate) in whole blood (WB) samples. WB samples were spiked with S-NO-HSA or DEA-NONOate (100 µmol/L or 200 µmol/L), and the NO release rate (nitrite/nitrate levels via HPLC) and antiplatelet efficacy (impedance aggregometry, platelet function analyzer, Cone-and-platelet analyzer, thrombelastometry) were assessed. S-NO-HSA had a significantly lower NO release compared to equimolar concentrations of DEA-NONOate. Virtually no antiplatelet action of S-NO-HSA was observed in WB samples, whereas DEA-NONOate significantly attenuated platelet function in WB. Impedance aggregometry measurements revealed that Amplitudes (slope: -0.04022 ± 0.01045 ohm/µmol/L, p = 0.008) and Lag times (slope: 0.6389 ± 0.2075 s/µmol/L, p = 0.0051) were dose-dependently decreased and prolonged by DEA-NONOate. Closure times (Cone-and-platelet analyzer) were dose-dependently prolonged (slope: 0.3738 ± 0.1403 s/µmol/L, p = 0.0174 with collagen/ADP coating; slope: -0.5340 ± 0.1473 s/µmol/L, p = 0.0019 with collagen/epinephrine coating) by DEA-NONOate. These results in WB further support the pharmacological potential of S-NO-HSA as an NO-donor due to its ability to presumably prevent bleeding events even at high concentrations up to 200 µmol/L.
ABSTRACT
Vitamins and carotenoids are organic compounds that are important for vital functions of the human organism. Since the human body is not able to synthesize most of these micronutrients, they need to be supplied by the intake of food or supplements. The aim of this study was to analyze whether a whole food based, encapsulated fruit, berry, and vegetable juice powder concentrate provides bioavailable carotenoids and vitamins A (all-trans retinol), E and C. Eighteen healthy subjects received 6 capsules a day for 8 weeks, which provided 2.91 mg ß-carotene, 490 µg vitamin A, 18.7 mg vitamin E, 159 mg vitamin C, 6.1 mg lutein and 1 mg lycopene. Plasma concentrations of several carotenoids and vitamins before and after supplementation were measured. After 8 weeks of supplementation, the plasma concentration of the following carotenoids increased significantly: α-carotene increased from 59.6 ± 22.4 nmol/L to 85.7 ± 24.2 nmol/L (p = 0.002), ß-cryptoxanthin from 106.7 ± 39.8 nmol/L to 151.9 ± 57.9 nmol/L (p = 0.017), and lycopene from 1.2 ± 0.5 µmol/L to 1.7 ± 0.5 µmol/L (p = 0.005). Significant increases were also observed for plasma concentrations of vitamin C from 70 ± 20 µmol/L to 90 ± 10 µmol/L (p < 0.001), all-trans retinol from 1.99 ± 0.24 µmol/L to 2.30 ± 0.66 µmol/L (p = 0.015), and α-tocopherol from 27 ± 6 µmol/L to 32 ± 6 µmol/L (p = 0.008). For those micronutrients with accepted plasma reference ranges, all observed increases levelled off around the upper limit of the individual reference range. The data demonstrate that the investigated supplement is able to increase plasma concentrations of certain carotenoids and vitamins of healthy subjects within 8 weeks.
Subject(s)
Vegetables , Vitamin A , Carotenoids , Fruit , Humans , Plasma , Powders , VitaminsABSTRACT
BACKGROUND: Guidelines recommend reducing saturated fat (SFA) intake to decrease cardiovascular disease (CVD) risk, but there is limited evidence on scalable and effective approaches to change dietary intake, given the large proportion of the population exceeding SFA recommendations. We aimed to develop a system to provide monthly personalized feedback and healthier swaps based on nutritional analysis of loyalty card data from the largest United Kingdom grocery store together with brief advice and support from a healthcare professional (HCP) in the primary care practice. Following a hybrid effectiveness-feasibility design, we tested the effects of the intervention on SFA intake and low-density lipoprotein (LDL) cholesterol as well as the feasibility and acceptability of providing nutritional advice using loyalty card data. METHODS AND FINDINGS: The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study is a parallel randomized controlled trial with a 3 month follow-up conducted between 21 March 2018 to 16 January2019. Adults ≥18 years with LDL cholesterol >3 mmol/L (n = 113) were recruited from general practitioner (GP) practices in Oxfordshire and randomly allocated to "Brief Support" (BS, n = 48), "Brief Support + Shopping Feedback" (SF, n = 48) or "Control" (n = 17). BS consisted of a 10-minute consultation with an HCP to motivate participants to reduce their SFA intake. Shopping feedback comprised a personalized report on the SFA content of grocery purchases and suggestions for lower SFA swaps. The primary outcome was the between-group difference in change in SFA intake (% total energy intake) at 3 months adjusted for baseline SFA and GP practice using intention-to-treat analysis. Secondary outcomes included %SFA in purchases, LDL cholesterol, and feasibility outcomes. The trial was powered to detect an absolute reduction in SFA of 3% (SD3). Neither participants nor the study team were blinded to group allocation. A total of 106 (94%) participants completed the study: 68% women, 95% white ethnicity, average age 62.4 years (SD 10.8), body mass index (BMI) 27.1 kg/m2 (SD 4.7). There were small decreases in SFA intake at 3 months: control = -0.1% (95% CI -1.8 to 1.7), BS = -0.7% (95% CI -1.8 to 0.3), SF = -0.9% (95% CI -2.0 to 0.2); but no evidence of a significant effect of either intervention compared with control (difference adjusted for GP practice and baseline: BS versus control = -0.33% [95% CI -2.11 to 1.44], p = 0.709; SF versus control = -0.11% [95% CI -1.92 to 1.69], p = 0.901). There were similar trends in %SFA based on supermarket purchases: control = -0.5% (95% CI -2.3 to 1.2), BS = -1.3% (95% CI -2.3 to -0.3), SF = -1.5% (95% CI -2.5 to -0.5) from baseline to follow-up, but these were not significantly different: BS versus control p = 0.379; SF versus control p = 0.411. There were small reductions in LDL from baseline to follow-up (control = -0.14 mmol/L [95% CI -0.48, 0.19), BS: -0.39 mmol/L [95% CI -0.59, -0.19], SF: -0.14 mmol/L [95% CI -0.34, 0.07]), but these were not significantly different: BS versus control p = 0.338; SF versus control p = 0.790. Limitations of this study include the small sample of participants recruited, which limits the power to detect smaller differences, and the low response rate (3%), which may limit the generalisability of these findings. CONCLUSIONS: In this study, we have shown it is feasible to deliver brief advice in primary care to encourage reductions in SFA intake and to provide personalized advice to encourage healthier choices using supermarket loyalty card data. There was no evidence of large reductions in SFA, but we are unable to exclude more modest benefits. The feasibility, acceptability, and scalability of these interventions suggest they have potential to encourage small changes in diet, which could be beneficial at the population level. TRIAL REGISTRATION: ISRCTN14279335.
Subject(s)
Cardiovascular Diseases/prevention & control , Energy Intake/physiology , Feedback , Adult , Body Mass Index , Cholesterol/metabolism , Diet/adverse effects , Female , Humans , Male , Middle AgedABSTRACT
Nutrition is emerging as a key factor in promoting healthy lifestyles in the growing elderly population across Europe. In this study, we examined the non-animal-derived food source consumption among the elderly European population to evaluate the actual contributions of these foods to the diet of the elders. We gathered 21 studies conducted in 17 European countries to evaluate the fruit, vegetable, and legume (along with their derived products) consumption among the elderly (>65 years) population. Foods' nutritional values were calculated and compared to the recommended intakes. A Bayesian multilevel hierarchical analysis was conducted to estimate the caloric intake of food categories and to compare the elderly and general adult populations. Although the lowest consumption was generally associated with the lowest nutrient and fiber intake, the reverse was not always the case. Concerning the general adult population, no differences in the related caloric intake of elders were noticed. Differences were instead evident when foods were divided into subclasses. Elderly populations consume fruit and fruit products, but they drink less fruit and vegetable juices and nectars. In conclusion, elderlies' fruit and vegetable consumption showed a peculiar pattern with respect to the general adult population, whose recognition could be helpful to address tailored policies. Constantly updated studies, including all the lifespan ages, are warranted to design tailored effective public health interventions.
Subject(s)
Diet, Healthy/statistics & numerical data , Fabaceae , Fruit , Nutrients/analysis , Vegetables , Aged , Aged, 80 and over , Bayes Theorem , Diet Surveys , Eating , Energy Intake , Europe , Female , Humans , Male , Multilevel Analysis , Nutrition Policy , Nutritive ValueABSTRACT
The major aim of this controlled, randomised, open-labelled, parallel-grouped, clinical trial was to investigate whether supplementation with different dosages of omega-3 fatty acids (0.5 g/d and 1 g/d) from a plant-based fatty acid supplement affected omega-3-indices (O3I) in well-nourished, healthy people. In addition, the combined ingestion of the plant-based fatty acid supplement, together with an encapsulated fruit, vegetable and berry (FVB) juice powder concentrate, was applied in order to observe the absorption of certain micronutrients and to examine some aspects related to the safe consumption of the products. The data demonstrate that the intake of only 0.5 g/day of omega-3 fatty acids from of a vegan supplement was able to increase the O3I significantly after 8 and 16 weeks. The combined ingestion with the FVB supplement concurrently increased serum concentrations of specific vitamins and carotenoids without effects on hepatic, kidney and thyroid function or changes in blood lipids.
Subject(s)
Dietary Supplements , Eicosapentaenoic Acid/blood , Fatty Acids, Omega-3/administration & dosage , Fatty Acids, Unsaturated/blood , Micronutrients/blood , Nutritional Physiological Phenomena , Plant Extracts/administration & dosage , Adult , Austria , Biological Availability , Capsules , Dose-Response Relationship, Drug , Fatty Acids, Omega-3/pharmacokinetics , Female , Fruit and Vegetable Juices , Healthy Volunteers , Humans , Male , Middle Aged , Plant Extracts/pharmacokinetics , PowdersABSTRACT
BACKGROUND: Interventions to reduce the saturated fat (SFA) content of food purchases may help reduce SFA consumption and lower cardiovascular risk. This factorial RCT aimed to examine the effect of altering the default order of foods and being offered a swap on the SFA content of food selected during an online shopping experiment. METHODS: UK adults who were the primary grocery shoppers for their household were recruited online and invited to select items in a custom-made experimental online supermarket using a 10-item shopping list. Participants were randomly allocated to one of four groups (i) to see products within a category ranked in ascending order of SFA content, (ii) receive an offer to swap to a product with less SFA, (iii) a combination of both interventions, or (iv) no intervention. The primary outcome was the difference in percentage energy from SFA in the shopping basket between any of the four groups. The outcome assessors and statistician were blinded to intervention allocation. RESULTS: Between March and July 2018, 1240 participants were evenly randomised and 1088 who completed the task were analysed (88%). Participants were 65% female and aged 38y (SD 12). Compared with no intervention (n = 275) where the percentage energy from SFA was 25.7% (SD 5.6%), altering the order of foods (n = 261) reduced SFA by [mean difference (95%CI)] -5.0% (- 6.3 to - 3.6) and offering swaps (n = 279) by - 2.0% (- 3.3 to - 0.6). The combined intervention (n = 273) was significantly more effective than swaps alone (- 3.4% (- 4.7 to - 2.1)) but not different than altering the order alone (- 0.4% (- 1.8 to 0.9)), p = 0.04 for interaction. CONCLUSIONS: Altering the default order to show foods in ascending order of SFA and offering a swap with lower SFA reduced percentage energy from SFA in an experimental online supermarket. Environmental-level interventions, such as altering the default order, may be a more promising way to improve food purchasing than individual-level ones, such as offering swaps. TRIAL REGISTRATION: ISRCTN13729526 https://doi.org/10.1186/ISRCTN13729526 26th February 2018.
Subject(s)
Consumer Behavior/statistics & numerical data , Dietary Fats , Food Preferences , Health Promotion/methods , Adult , Diet/statistics & numerical data , Female , Humans , Male , Middle AgedABSTRACT
INTRODUCTION: A diet high in saturated fat (SFA) increases the risk of cardiovascular disease (CVD) and intakes in the UK exceed dietary recommendations. The Primary Care Shopping Intervention for Cardiovascular Disease Prevention (PC-SHOP) study aims to test the effect of an intervention for people with raised low-density lipoprotein (LDL) cholesterol involving health professional (HP) advice alone, or in combination with personalised feedback based on nutritional analysis of grocery store loyalty card data, on SFA intake and blood lipids in comparison with no intervention. METHODS AND ANALYSIS: PC-SHOP is a three-arm parallel randomised controlled trial with an allocation ratio of 1:3:3 ('no intervention': n=16, 'brief support': n=48, 'brief support plus shopping feedback': n=48, respectively). Participants with raised LDL will be recruited from general practitioner (GP) practices for a 3-month intervention period. In brief support, an HP will deliver a behaviourally informed 10 min consultation and provide a written self-help guide to inform and motivate people to reduce their SFA intake. In brief support plus shopping feedback, the participants will receive the same HP-led behavioural support and, based on data from their grocery store loyalty card, personalised feedback on the SFA content of their grocery shopping, identifying high SFA purchases and suggesting swaps to similar but lower SFA items.Measurements for the primary and secondary outcomes will be collected at baseline and at follow-up (3 months). The primary outcome measure will be the between-group difference in the reduction of SFA intake between baseline and follow-up. Secondary outcomes include changes in blood lipids and SFA content of food purchases, with process measures to consider the feasibility and acceptability of the intervention. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the National Health Service Health Research Authority Research Ethics Committee (Ref: 17/SC/0168). The trial findings will be disseminated to academic and HPs through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results will be communicated to relevant stakeholders, including policymakers and retailers. TRIAL REGISTRATION NUMBER: ISRCTN14279335; Pre-results.
Subject(s)
Cardiovascular Diseases/prevention & control , Diet, Healthy , Dietary Fats/adverse effects , Adult , Cholesterol, LDL/blood , Female , Humans , Male , Randomized Controlled Trials as Topic , Single-Blind MethodABSTRACT
BACKGROUND & AIMS: Unrecognized nutritional issues may delay recovery in hospitalized infants. It has been proposed that nutritional risk screening should be performed at hospital admission, but few tools include infants. The aim of this study was to develop and test a tool to identify sick infants in need of dietetic input. METHODS: Hospitalised infants were recruited from hospitals in the United Kingdom (UK), Greece and Iran. Weight, skinfold thickness and mid upper arm circumference (MUAC) were measured, with detailed dietetic assessment in the UK and Greece. Simple screening questions were used in the UK cohort to formulate a score (infant early nutrition warning score-iNEWS) which was then validated in the Greek and Iranian groups. RESULTS: After dietetic assessment, 20 (9.6%) UK and 22 (22%) Greek infants were rated as needing dietetic input. Underweight, poor weight gain/loss and reduced intake were all independent predictors of perceived need for dietetic input in stepwise multivariate regression analysis. The score based on these items (iNEWS), had 84% sensitivity, 91% specificity and 49% positive predictive value to predict need for dietetic input in the UK cohort. In the Greek cohort this was 86%, 78% and 53% respectively. In all three countries, infants with high iNEWS had significantly lower average skinfold thickness (between -1 and -1.8 SD, p < 0.0001) and MUAC (between -1.8 and -2 SD, p < 0.0001) than those at low risk. CONCLUSIONS: iNEWS, a simple nutritional risk tool, identifies most hospitalised infants who need dietetic input. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03323957.
Subject(s)
Infant Nutrition Disorders/diagnosis , Nutrition Assessment , Nutritional Status/physiology , Female , Hospitalization , Humans , Infant , Infant Nutritional Physiological Phenomena/physiology , Male , Risk Assessment , Sensitivity and SpecificityABSTRACT
BACKGROUND: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. METHODS: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). INTERPRETATION: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. FUNDING: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).
Subject(s)
Behavior Therapy/organization & administration , Obesity/therapy , Primary Health Care/organization & administration , Weight Reduction Programs/organization & administration , Adult , Aged , Behavior Therapy/economics , Body Weight , Cost-Benefit Analysis , England , Female , Follow-Up Studies , Health Care Costs/statistics & numerical data , Humans , Male , Middle Aged , Obesity/economics , Obesity/physiopathology , Primary Health Care/economics , Quality of Life , Referral and Consultation/organization & administration , Socioeconomic Factors , State Medicine/economics , State Medicine/organization & administration , Time Factors , Weight Loss , Weight Reduction Programs/economicsABSTRACT
BACKGROUND: Cardiovascular disease has a multifactorial aetiology with a number of both modifiable and non-modifiable risk factors. Although evidence indicates that dietary intake plays an important role, few studies have focused on the effect of fruit and vegetable consumption on early markers of vascular function. Therefore, we hypothesised that supplementation with capsules containing a combination of fruit and vegetable extracts over 12 weeks can significantly modulate biomarkers of vascular function compared with a control group receiving placebo. METHODS/DESIGN: This is a double-blind, randomised controlled trial that includes overweight and obese but otherwise healthy participants. Participants are randomly allocated to one of two groups: active supplementation (encapsulated fruit and vegetable powder) or placebo taken twice daily for 12 weeks, whereas both groups will be given the '5-A-Day' dietary advice. The primary outcome is to measure changes to the carotid intima media thickness (cIMT) between the two groups from baseline (test visit 1) to 12 weeks later (test visit 2). The secondary outcomes include macro- and microvascular changes and changes to blood markers. DISCUSSION: In addition to the primary and secondary objectives, this explanatory trial incorporates potential novel biomarkers such as trimethylamine-N-oxide (TMAO) and lipopolysaccharide (LPS). TRIAL REGISTRATION: ISRCTN14315618. Registration date 27 February 2014.
Subject(s)
Clinical Protocols , Dietary Supplements , Fruit , Plant Extracts/administration & dosage , Vasodilation/drug effects , Vegetables , Adult , Aged , Carotid Intima-Media Thickness , Double-Blind Method , Humans , Lipopolysaccharides/blood , Middle Aged , Outcome Assessment, Health Care , Pulse Wave AnalysisABSTRACT
BACKGROUND: The net clinical benefit of high-energy nutritional supplements (HENSDs) consumption is lower than expected. OBJECTIVES: To investigate the extent to which consumption of oral HENSD in the fasted state reduces energy intake in slim females during consecutive breakfast and lunch, and whether this relates to changes in appetite and metabolic appetite regulators. DESIGN: Twenty three females of 24.4 ± 2.8 years with BMI of 18.2 ± 0.8 kg/m(2) consumed HENSD (2.5 MJ) or PLACEBO (0.4 MJ) in fasted state in a single blind randomized cross-over study. Appetite and metabolic rate measurements and blood collection were conducted prior to and during 240 min after the intake of the supplements. Energy intake was recorded during ad libitum buffet breakfast and lunch served 60 min and 240 min post supplementation respectively. RESULTS: Energy intake during breakfast was significantly (P < 0.01) lower in the HENSD trial but the net cumulative effect on energy intake was 1.07 ± 0.34 MJ higher in the HENSD compared to PLACEBO. Plasma concentration of CCK and PYY and insulin and were significantly (P < 0.05) higher in the HENSD trial while appetite measures were not significantly different between HENSD and PLACEBO trials. Correlations for the within participant relations between the responses of plasma hormones and appetite scores were significant (P < 0.05) for PYY and insulin but not CCK. The energy expended above resting metabolic rate was significantly (P < 0.05) higher in the HENDS trial but relative increase in energy expenditure was not significantly different between the two trials. CONCLUSION: Oral high-energy nutritional supplements have a partial and relatively short lived suppressive action on energy intake and can be expected to increase net energy intake by approximately half the energy value of the supplement consumed.
Subject(s)
Appetite Regulation/drug effects , Dietary Supplements , Energy Intake/drug effects , Energy Metabolism , Adult , Appetite Regulation/physiology , Body Mass Index , Breakfast , Cholecystokinin/blood , Cross-Over Studies , Fasting/blood , Female , Humans , Insulin/blood , Lunch , Peptide YY/blood , Single-Blind Method , Young AdultABSTRACT
OBJECTIVE: Larger food portions lead to increased intake but the mechanism behind this effect is unclear. We investigated the effect of portion size on bite size, eating rate, deceleration rate, and meal duration. DESIGN AND METHODS: Thirty-seven overweight women attended 5 visits after a 3 h fast and consumed a 229, 303, 400, 529 or 700 g portion of a lunch meal in random order. Meal eating parameters were measured with the Sussex Ingestion Pattern Monitor. Data were analyzed with mixed effects models. RESULTS: Average bite size increased by 0.22 g for every 100 g increase in portion size (p=0.001); portion size had a non-linear effect on eating rate, increasing with portion sizes up to about 540 g (p=0.01). Deceleration rate (reduction in speed of eating) decreased by 20% (p<0.001) and meal duration increased by 22.5% for every 100 g increase in portion size (p<0.001), relative to the smallest portion. CONCLUSIONS: Increasing portion size led to a larger bite size and faster eating rate, but a slower reduction in eating speed during the meal. These changes may underlie greater energy intakes with exposure to large portions. Interventions to reduce bite size and slow eating rate may provide individuals with strategies to reduce the risk of overconsumption.