Metabolic management in overweight subjects with naive impaired fasting glycaemia by means of a highly standardized extract from Cynara scolymus: a double-blind, placebo-controlled, randomized clinical trial.

The aim of this study is to evaluate the efficacy of a dietary supplementation with an extract from Cynara scolymus (Cs) on the glucose pattern in a group of patients with naïve impaired fasting glycaemia (IFG). A randomized, double-blind, placebo-controlled trial has been performed in 55 overweight subjects with IFG (fasting blood glucose [FBG]: 6.11 ± 0.56 mmol/l). These subjects were randomly assigned to supplement their diet with either an extract from Cs (600 mg/d) (26 subjects) or placebo (29 matched subjects) for 8 weeks. The decrease of FBG was the primary endpoint. The assessment of Homeostatic Metabolic Assessment (HOMA), glycosylated haemoglobin, A1c-Derived Average Glucose (ADAG), lipidic pattern and anthropometric parameters were the secondary endpoints. The within groups and percent changes from baseline were analyzed by the signed rank test. The comparison between groups was performed by Wilcoxon's two sample test. The supplemented group had significant decreases of: FBG (-9.6%), HOMA (-11.7%), glycosylated haemoglobin (-2.3%), ADAG (-3.1%) and lipidic pattern. The placebo group did not show any significant difference. Compared with the placebo, the supplemented group showed a significant difference in FBG, HOMA and lipidic pattern. These data demonstrate the efficacy of Cs extract on the reduction of glycometabolic parameters in overweight subjects with IFG.

Acute effect on satiety, resting energy expenditure, respiratory quotient, glucagon-like peptide-1, free fatty acids, and glycerol following consumption of a combination of bioactive food ingredients in overweight subjects.

OBJECTIVE: A combination of bioactive food ingredients (capsaicinoids, epigallocatechin gallate, piperin, and l-carnitine, CBFI) may promote satiety and thermogenesis. The study was conducted in order to assess whether there is any effect on satiety, resting energy expenditure (REE), respiratory quotient, glucagon-like peptide-1 (GLP-1), free fatty acids (FFA) and glycerol release, following a standardized mixed meal with or without single consumption of a CBFI. DESIGN: An 8-week randomized double-blind placebo-controlled trial. SETTING: Dietetic and Metabolic Unit, Azienda di Servizi alla Persona, University of Pavia and "Villa delle Querce" Clinical Rehabilitation Institute, Rome, Italy. PARTICIPANTS: Thirty-seven overweight adults (body mass index [BMI]: 25-35). INTERVENTION: Nineteen overweight subjects were included in the supplemented group (14 women, 5 men; age 46.4 ± 6.4; BMI: 30.5 ± 3.3) and 18 in the placebo group (13 women, 5 men; age 40.8 ± 11.5; BMI: 30.1 ± 2.6). Satiety was assessed using 100-mm visual analogue scales (VAS) and the area under the curve was calculated. RESULTS: All measured parameters increased significantly in comparison with baseline in response to meal, both with CBFI and with placebo. However, throughout the study day, the supplemented group experienced a significantly greater increase than the placebo group in their sensation of satiety following acute administration of the supplement. CONCLUSION: CBFI may therefore be of great value in the treatment of overweight patients by increasing satiety and stimulating thermogenesis.

Health-promoting properties of artichoke in preventing cardiovascular disease by its lipidic and glycemic-reducing action.

The artichoke, Cynara scolymus, is one of the most ancient plants grown in the world, and its extracts, obtained from different parts of the plant (leaves, fruits and roots), have been used as medicaments from time immemorial. The pharmacological and therapeutic effects of the artichoke on the liver had already been well known in the 17th century. Modern studies started in the last century confirmed the stimulating properties of artichoke extracts on the liver and gallbladder. The ensuing wave of research was initially focused on the patent liver-stimulating, diuretic and choleretic effects exerted by artichoke preparations on both animals and man, then discovering such other therapeutic properties as the hypolipemizing activity, antioxidant activity and hypoglycemizing activity. This review enumerates the most significant studies that have highlighted these therapeutic properties. Complementary medicine information needs to be incorporated into clinical practice and patient and professional education, in addition to adequate education about proper nutrition. Awareness of the widespread use of complementary and alternative medicine by people with metabolic disorders is crucial for healthcare professionals in order to prevent cardiovascular disease.

Update on nutrients involved in maintaining healthy bone

Osteoporosis is a leading cause of morbidity and mortality in the elderly and influences quality of life, as well as life expectancy. Currently, there is a growing interest among the medical scientists in search of specific nutrients and/or bioactive compounds of natural origin for the prevention of disease and maintenance of bone health. Although calcium and vitamin D have been the primary focus of nutritional prevention of osteoporosis, a recent research has clarified the importance of several additional nutrients and food constituents. Based on this review of the literature, supplementation with vitamins B, C, K, and silicon could be recommended for proper maintenance of bone health, although further clinical studies are needed. The results of studies on long-chain polyunsaturated fatty acids, potassium, magnesium, copper, selenium, and strontium are not conclusive, although studies in vitro and in animal models are interesting and promising (AU)

La osteoporosis es una de las principales causas de morbimortalidad en ancianos y tiene repercusiones en la calidad y esperanza de vida. Actualmente existe un interés creciente por parte de los investigadores médicos en los nutrientes y compuestos bioactivos de origen natural que puede ser útiles para la prevención de la enfermedad y el mantenimiento de la salud ósea. Si bien el calcio y la vitamina D han sido los nutrientes más destacados en la prevención de la osteoporosis, investigaciones recientes han aportado información sobre la importancia de otros nutrientes y componentes alimentarios. En base a esta revisión de la literatura, se puede recomendar la suplementación con vitaminas B, C, K y silicio para el mantenimiento adecuado de la salud ósea, aunque se necesitan más estudios clínicos. Los resultados de estudios sobre la cadena larga de ácidos grasos poliinsaturados, potasio, magnesio, cobre, selenio, estroncio no son concluyentes, aunque los estudios in vitro y en modelos animales son interesantes y prometedores (AU)

Update on nutrients involved in maintaining healthy bone.

Osteoporosis is a leading cause of morbidity and mortality in the elderly and influences quality of life, as well as life expectancy. Currently, there is a growing interest among the medical scientists in search of specific nutrients and/or bioactive compounds of natural origin for the prevention of disease and maintenance of bone health. Although calcium and vitamin D have been the primary focus of nutritional prevention of osteoporosis, a recent research has clarified the importance of several additional nutrients and food constituents. Based on this review of the literature, supplementation with vitamins B, C, K, and silicon could be recommended for proper maintenance of bone health, although further clinical studies are needed. The results of studies on long-chain polyunsaturated fatty acids, potassium, magnesium, copper, selenium, and strontium are not conclusive, although studies in vitro and in animal models are interesting and promising.

Beneficial effects of artichoke leaf extract supplementation on increasing HDL-cholesterol in subjects with primary mild hypercholesterolaemia: a double-blind, randomized, placebo-controlled trial.

The aim of this study was to evaluate the effects of artichoke leaf extract (ALE) supplementation (250 mg, 2 b.i.d.) on the lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed on 92 overweight subjects with primary mild hypercholesterolaemia for 8 weeks. Forty-six subjects were randomized to supplementation (age: 54.2 ± 6.6 years, body mass index (BMI): 25.8 ± 3.9 kg/m(2), male/female: 20/26) and 46 subjects to placebo (age: 53.8 ± 9.0 years, BMI: 24.8 ± 1.6 kg/m(2), male/female: 21/25). Verum supplementation was associated with a significant increase in mean high-density lipoprotein (HDL)-cholesterol (p < 0.001) and in mean change in HDL-cholesterol (HDL-C) (p = 0.004). A significantly decreased difference was also found for the mean change in total cholesterol (p = 0.033), low-density lipoprotein (LDL)-cholesterol (p < 0.001), total cholesterol/HDL ratio (p < 0.001) and LDL/HDL ratio (p < 0.001), when verum and placebo treatment were compared. These results indicate that ALE could play a relevant role in the management of mild hypercholesterolaemia, favouring in particular the increase in HDL-C, besides decreasing total cholesterol and LDL-cholesterol.

Improvement in insulin resistance and favourable changes in plasma inflammatory adipokines after weight loss associated with two months' consumption of a combination of bioactive food ingredients in overweight subjects.

This randomized, double blind, placebo-controlled, 8 week trial assessed the efficacy on metabolic changes produced by a consumption of a combination of bioactive food ingredients (epigallocatechin gallate, capsaicins, piperine and L-carnitine) versus a placebo, as part of a therapeutic 'lifestyle change' diet, in 86 overweight subjects. Forty-one patients (2/14 F/M; age 43.7 ± 8.5; BMI 30.3 ± 3.5 kg/m(2)) were randomized to the supplemented group and 45 (29/16; age 40.7 ± 10.2; BMI 30.0 ± 2.7) to the control group. We observed that consumption of the dietary supplement was associated with a significantly greater decrease in insulin resistance, assessed by homostasis model assessment (p < 0.001), leptin/adiponectin ratio (p < 0.04), respiratory quotient (p < 0.008). LDL-cholesterol levels (p < 0.01). Moreover, statistically significant differences were recorded between the two groups in relation to urinary norepinephrine levels (p < 0.001). Leptin, ghrelin, C-reactive protein decreased and resting energy expenditure increased significantly in the supplemented group (p < 0.05, 0.03, 0.02 and 0,02 respectively), but not in the placebo group; adiponectin decreased significantly in the placebo group (0.001) but not in the supplemented group, although no statistical significance between the groups was elicited. BMI, fat mass (assessed by DXA) and vascular endothelial growth factor significantly decreased, whilst the resting energy expenditure/free fat mass significantly increased in both groups. In general, a greater change was recorded in the supplemented group compared to the placebo, although no statistically significant difference between the two groups was recorded. These results suggest that the combination of bioactive food ingredients studied might be useful for the treatment of obesity-related inflammatory metabolic dysfunctions.

Comparison between the AA/EPA ratio in depressed and non depressed elderly females: omega-3 fatty acid supplementation correlates with improved symptoms but does not change immunological parameters.

BACKGROUND: Depression is one of the most frequently missed diagnoses in elderly people, with obvious negative effects on quality of life. Various studies have shown that long chain omega-3 polyunsaturated fatty acids (n-3 PUFA) may be useful in its management. Our objective was to evaluate whether a supplement containing n-3 PUFA improves depressive symptoms in depressed elderly patients, and whether the blood fatty acid pattern is correlated with these changes. METHODS: The severity of depressive symptoms according to the Geriatric Depression Scale (GDS), blood fatty acid composition and erythrocyte phospholipids were analyzed in 46 depressed females aged 66-95y, diagnosed with depression according to DSMIV, within the context of a randomized, double-blind, placebo-controlled trial. 22 depressed females were included in the intervention group (2.5 g/day of n-3 PUFA for 8 weeks), and 24 in the placebo group. We also measured immunological parameters (CD2, CD3, CD4, CD8, CD16, CD19 and cytokines (IL-5, IL-15). RESULTS: The mean GDS score and AA/EPA ratio, in whole blood and RBC membrane phospholipids, were significantly lower after 2 months supplementation with n-3 PUFA. A significant correlation between the amelioration of GDS and the AA/EPA ratio with some immunological parameters, such as CD2, CD19, CD4, CD16 and the ratio CD4/CD8, was also found. Nevertheless, omega-3 supplementation did not significantly improve the studied immunological functions. CONCLUSIONS: n-3 PUFA supplementation ameliorates symptoms in elderly depression. The n-3 PUFA status may be monitored by means of the determination of whole blood AA/EPA ratio.

Effects of a diet integration with an oily emulsion of DHA-phospholipids containing melatonin and tryptophan in elderly patients suffering from mild cognitive impairment.

Age-related changes in nutritional status can play an important role in brain functioning. Specific nutrient deficiencies in the elderly may exacerbate pathological processes in the brain. Consequently, the potential of nutritional intervention to prevent or delay cognitive impairment and the development of dementia is an important topic. A randomized, double-blind, placebo-controlled trial has been performed in 25 elderly subjects (86 ± 6 years, 20 females, 5 males) with mild cognitive impairment (MCI). These subjects were randomly assigned to supplement their diet with either an oily emulsion of docosahexaenoic acid (DHA)-phospholipids containing melatonin and tryptophan (11 subjects) or a placebo (14-matched subjects) for 12 weeks. The main aim of this study was to evaluate the efficacy of the dietary supplement on cognition, by the assessment at the start and after 12 weeks of: (1) Orientation and other cognitive functions: Mini-Mental State Examination (MMSE); (2) Short-term memory: digit, verbal, and spatial span (digit span; verbal span; Corsi's test); (3) Long-term memory: Rey's auditory-verbal learning test; 'short story' test; Rey-Osterrieth complex figure (recall); (4) Attentional abilities: attentive matrices; (5) Executive functions: Weigl's sorting test; phonological fluency 'FAS'; (6) Visuo-constructional and visuo-spatial abilities: copy of simple drawings; Rey-Osterrieth complex figure (copy); (7) Language: semantic fluency; (8) Mood: Geriatric Depression Scale (GDS). Moreover, Sniffin' Sticks olfaction test and Mini Nutritional Assessment (MNA) have been performed. After 12 weeks, a significant treatment effect for the MMSE (P < 0.001) and a positive trend for the semantic verbal fluency was found in the supplement group (P < 0.06). A significant treatment effect was found out for the olfactory sensitivity assessment (P < 0.009). As regards the nutrition evaluation, after 12 weeks of treatment the supplemented group showed an improvement in the MNA score with a significant difference relative to placebo (P < 0.005). Older adults with MCI had significant improvements in several measures of cognitive function when supplemented with an oily emulsion of DHA-phospholipids containing melatonin and tryptophan for 12 weeks, compared with the placebo.

[Update on the therapeutic qualities of the rice bran in the treatment of dyslipidemia and chemo-prevention]. / Composti della pula di riso nella terapia delle dislipidemie e nella prevenzione oncologica. Un aggiornamento.

Rice (Oryza Sativa) bran, comprising 10% of the total rice grain, is a by-product of the rice milling industry with world production of about 50-60 million metric tons per year. Rice bran is an excellent source of antioxidants, vitamins, fatty acids, protein, carbohydrates and other critical minerals and nutrients. In addition to being an excellent source of nutrients, rice bran is reported to be rich in phytonutrients that provide health benefits associated with blood sugar control, cholesterol metabolism, prostate health and chemoprevention. This paper focus on these phytonutrients and their effect on health.

Effect of essential amino acid supplementation on quality of life, amino acid profile and strength in institutionalized elderly patients.

BACKGROUND & AIMS: This study assessed the efficacy of supplemented essential amino acids on depressive symptoms, nutrition, muscle function, daily physical activity, and health-related quality of life (HRQoL) of institutionalized elderly patients. METHODS: Forty-one patients (58.5% women; mean age 79.8 yrs) with sequelae of coronary artery disease (73%), femoral fracture (34%), were randomly assigned to receive oral essential amino acids 4 gr 2 times a day for 8 weeks or isocaloric placebo. Before randomization and 8 weeks after the protocol started, the following variables were measured: depressive symptoms (Geriatric Depression Scale, GDS), nutritional panel (Mini Nutritional Assessment, MNA; serum albumin and prealbumin levels), muscle strength (Hand Grip, HG), Activity Daily Life (ADL), Quality of Life (SF-36, HRQoL) and amino acid profile. RESULTS: Compared with the placebo group, EAA patients improved nutrition (MNA score 22.6 ± 1.5 post vs 21.8 ± 1.6 pre; p < 0. 04, albumin g/dl 4.04 ± 0.35 post vs 3.88 ± 0.3 pre; p < 0.01), GDS(score 10.3 ± 1.75 post vs 13.85 ± 3.37 pre; p < 0.001), HG (Kg 19.75 ± 1.7 post vs 18.68 ± 1.36 pre; p = 0.001), ADL (p < 0.04) and both physical and mental components of SF-36 (p < 0.002). CONCLUSIONS: Oral supplementation with essential amino acids improved several determinants of quality of life in institutionalized elderly patients, including depressive symptoms, nutrition, muscle function and daily life activity.

Appetite control and glycaemia reduction in overweight subjects treated with a combination of two highly standardized extracts from Phaseolus vulgaris and Cynara scolymus.

The management of overweight may include the use of dietary supplements targeted to favour the increase of the satiation associated with a decrease in blood glucose and lipid levels. The aim of this study was to evaluate the efficacy of a dietary supplementation with an extract from Phaseolus vulgaris and Cynara scolymus, on satiation, the glucose and lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed in 39 overweight subjects (20 supplemented group, 19 placebo group) for 2 months. The modification of satiation, by Haber's scale, was the primary end-point, and the variation of the glucose and lipid pattern, of the anthropometric parameters and of the psychodynamic tests score were the secondary end-points. At the end of treatment, the net change of the Haber's mean score increased significantly in the intervention group. The net change of the glycaemia and of the dietary restriction score of the three factor eating questionnaire (TFEQ), were reduced significantly only in the intervention group. Moreover, in the supplemented group, the homeostasis model assessment, the body mass index and the susceptibility-to-hunger score of the TFEQ, decreased significantly after intervention; these parameters did not change in the controls. This treatment appears potentially useful in the management of overweight and dysglycaemia.

The effect of melatonin, magnesium, and zinc on primary insomnia in long-term care facility residents in Italy: a double-blind, placebo-controlled clinical trial.

OBJECTIVES: To determine whether nightly administration of melatonin, magnesium, and zinc improves primary insomnia in long-term care facility residents. DESIGN: Double-blind, placebo-controlled clinical trial. SETTING: One long-term care facility in Pavia, Italy. PARTICIPANTS: Forty-three participants with primary insomnia (22 in the supplemented group, 21 in the placebo group) aged 78.3 ± 3.9. INTERVENTION: Participants took a food supplement (5 mg melatonin, 225 mg magnesium, and 11.25 mg zinc, mixed with 100 g of pear pulp) or placebo (100 g pear pulp) every day for 8 weeks, 1 hour before bedtime. MEASUREMENTS: The primary goal was to evaluate sleep quality using the Pittsburgh Sleep Quality Index. The Epworth Sleepiness Scale, the Leeds Sleep Evaluation Questionnaire (LSEQ), the Short Insomnia Questionnaire (SDQ), and a validated quality-of-life instrument (Medical Outcomes Study 36-item Short Form Survey (SF-36)) were administered as secondary end points. Total sleep time was evaluated using a wearable armband-shaped sensor. All measures were performed at baseline and after 60 days. RESULTS: The food supplement resulted in considerably better overall PSQI scores than placebo (difference between groups in change from baseline PSQI score=6.8; 95% confidence interval=5.4-8.3, P<.001). Moreover, the significant improvements in all four domains of the LSEQ (ease of getting to sleep, P<.001; quality of sleep, P<.001; hangover on awakening from sleep, P=.005; alertness and behavioral integrity the following morning, P=.001), in SDQ score (P<.001), in total sleep time (P<.001), and in SF-36 physical score (P=.006) suggest that treatment had a beneficial effect on the restorative value of sleep. CONCLUSION: The administration of nightly melatonin, magnesium, and zinc appears to improve the quality of sleep and the quality of life in long-term care facility residents with primary insomnia.

Effect of omega-3 fatty acids supplementation on depressive symptoms and on health-related quality of life in the treatment of elderly women with depression: a double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVE: In elderly individuals, depression is one of the most frequently missed diagnoses with negative effects on quality of life. The authors investigated whether a supplement containing long-chain omega-3 polyunsaturated fatty acids (n-3 LCPUFA) improves depressive symptoms and health-related quality of life (HRQoL) in depressed elderly patients. DESIGN: Eight-week, randomized, double-blind, placebo-controlled trial. SETTING: Nursing home in Pavia, Italy. PARTICIPANTS: Forty-six depressed women, aged 66-95 years. INTERVENTION: Twenty-two depressed women were included in the intervention group (n-3 group, which received 2.5 g/d of n-3 LCPUFA, with 1.67 g of eicosapentaenoic acid [EPA] and 0.83 g of docosahesaenoic acid [DHA]), and 24 patients were included in the placebo group. The primary endpoint was the improvement of depressive symptoms, as evaluated by the Geriatric Depression Scale (GDS). Secondary endpoints were the evaluation of HRQoL, by using the Short-Form 36-Item Health Survey (SF-36), and modifications of erythrocyte membrane phospholipids fatty acid profile. All variables were assessed before and after the treatment period of 8 weeks. RESULTS: The mean GDS at 8 weeks was significantly lower compared with the n-3 group. The SF-36 physical and mental components were significantly increased in the intervention group. Compliance was good, as confirmed by erythrocyte membrane phospholipid FA concentrations, with a significant increase of EPA and DHA in the intervention group. CONCLUSION: Supplementation with n-3 LCPUFA is efficacious in the amelioration of depressive symptoms and quality of life in the treatment of depressed elderly female patients.

Administration of a dietary supplement ( N-oleyl-phosphatidylethanolamine and epigallocatechin-3-gallate formula) enhances compliance with diet in healthy overweight subjects: a randomized controlled trial.

Many studies have found that N-oleyl-ethanolamine (NOE), a metabolite of N-oleyl-phosphatidylethanolamine (NOPE), and epigallocatechin-3-gallate (EGCG) inhibit food intake. The main aim of this study was to evaluate the efficacy of 2 months of administration of an oily NOPE-EGCG complex (85 mg NOPE and 50 mg EGCG per capsule) and its effect on compliance with diet in healthy, overweight people. Secondary end-points of the study were to compare body composition, metabolic parameters, sensation of appetite, depressive symptoms and severity of binge eating. Using a parallel-arm, double-blind, placebo-controlled design, 138 healthy, overweight women (106) and men (thirty-two) were randomly assigned to one of two groups: (1) the treatment group (seventy-one patients: fifty-three females, eighteen males) taking two capsules per day of an oral supplement or (2) the placebo group (sixty-seven patients: fifty-three females, fourteen males). Both groups observed a 3344 kJ/d energy restriction. All parameters were assessed both before onset and after 2 months on the supplement. Dropout was 6 % in the NOPE-EGCG group and 27 % in the placebo group (P < 0.001). The treatment induced a significant weight reduction in both groups ( - 3.28 kg and - 2.67 kg in NOPE-EGCG and placebo, respectively); the weight changes were not significantly different between the groups. NOPE-EGCG treatment improved insulin resistance (P < 0.001), the sensation feelings of fullness (P < 0.05), depressive symptoms (P < 0.004) and severity of binge eating (P < 0.0001).