Fast determination of virgin olive oil phenolic metabolites in human high-density lipoproteins.

In recent years it has been confirmed that the consumption of olive oil prevents the oxidation of biomolecules owing to its monounsaturated fatty acids (MUFA) and phenolic content. The main objective of the study was to develop an ultra-high-performance liquid chromatography (UHPLC) tandem mass spectrometry (MS/MS) method for the determination of phenolic compounds in human high-density lipoprotein (HDL) samples. At the same time, the influence of olive oil consumption on the phenolic metabolite levels was evaluated in a European population. The participants were 51 healthy men, aged 20-60. They were randomized to two consecutive intervention periods with the administration of raw olive oil with low and high polyphenolic content. The UHPLC-MS/MS analytical method has been validated for hydroxytyrosol and homovanillic acid in terms of linearity (r(2) = 0.99 and 1.00), repeatability (5.7 and 6.5%) reproducibility (6.2 and 7%), recovery (98 to 97%), limits of detection (1.7 to 1.8 ppb) and quantification (5.8 and 6.3 ppb).The levels of the studied metabolites increased significantly after high polyphenolic content virgin olive oil ingestion (p <0.05) compared with lowpolyphenolic content olive oil. Virgin olive oil consumption increases the levels of phenolic metabolites in HDL and thus provides human HDL with more efficient antioxidant protection.

Effect of olive oil consumption on serum resistin concentrations in healthy men.

Resistin has been linked to atherosclerosis and inflammatory processes in humans. Some polyphenols have been shown to downregulate resistin expression in adipocytes. The effects of olive oil phenolics on resistin are not known; therefore, we investigated the impact of olive oil consumption on serum resistin as a function of the olive oils' phenolic content. In a randomized, controlled, cross-over study 38 healthy German men aged 38+/-2 years replaced their usual consumption of raw fat during 3 periods of 3 weeks each by 25 ml of virgin, common and refined olive oil varying in phenolic content. Serum resistin, blood lipids and urine biomarkers of subjects' compliance were analysed at baseline and at the end of each intervention period. The integration of olive oil in the subjects' habitual diet led to a decrease in total cholesterol (p=0.025) and triglycerides (p=0.013) independent of the content of phenolic compounds in the oil. Serum resistin concentrations were not affected by the olive oils' phenolic content. After low phenolic olive oil consumption, a decrease in serum resistin level was observed compared to medium and high phenolic olive oil (-0.4+/-0.1 ng/ml; p=0.040). Our results suggest that olive oil consumption has only marginal beneficial effects on serum resistin levels.

Cholesterol-lowering effects of a new isolated soy protein with high levels of nondenaturated protein in hypercholesterolemic patients.

This study was undertaken to compare the effects on plasma cholesterol concentration of a new isolated soy protein in which the protein structure is kept in its native, nondenaturated form (verum 1) versus a conventional isolated soy protein (verum 2) and milk protein (placebo). This prospective, randomized, double-blind, placebo-controlled study was conducted in an outpatient clinical study center in Berlin, Germany. Over 8 wk, 120 patients (total cholesterol, 5.2-7.8 mmol/L) were given verum 1, verum 2, or placebo at a dosage of 25 g protein daily. At the end of the treatment period, total cholesterol levels were significantly reduced by 10.7% in the verum 1 group compared with placebo (P<.001), and levels were reduced by 5.8% in the verum 2 group (P=.008). The difference between the 2 verum groups was statistically significant (P=.008). Low-density lipoprotein cholesterol levels were significantly reduced with nondenaturated isolated soy protein only: levels were reduced by 9.4% in the verum 1 group (P=.002) and by 4.9% in the verum 2 group (P=.107). Again, the difference between the verum groups was significant (P=.05). The results of this study confirm that supplementation with isolated soy protein can lead to significant reductions in plasma concentrations of total and low-density lipoprotein cholesterol. These reductions are significantly more pronounced with an isolated soy protein that maintains the native protein structure than with a commercially available reference isolated soy protein.

Arabinoxylan consumption decreases postprandial serum glucose, serum insulin and plasma total ghrelin response in subjects with impaired glucose tolerance.

OBJECTIVE: Arabinoxylan (AX) consumption is associated with metabolic improvement during diabetes and with modulation of ghrelin, an orexigenic gut hormone. The effect of AX consumption on ghrelin secretion in disturbed metabolic states is unknown. Therefore, we investigated the postprandial responses to AX consumption of serum glucose, insulin and triglycerides and plasma total and acylated ghrelin in subjects with impaired glucose tolerance (IGT). DESIGN: Randomized, single-blind, controlled, crossover intervention trial. SUBJECTS: Seven female and four male adults with IGT, aged 55.5 years, and body mass index (BMI) 30.1 kg/m(2). INTERVENTION: Subjects received either placebo or 15 g AX supplement for 6 weeks with a 6-week washout period in-between. MAIN OUTCOME MEASUREMENTS: Postprandial responses of serum glucose, insulin and triglycerides, and plasma total and acylated ghrelin after a liquid meal challenge test (LMCT) measured at the beginning and at the end of the dietary intervention at -20, -5, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210 and 240 min. RESULTS: After LMCT, AX consumption resulted in lower postprandial responses in serum glucose, insulin and triglycerides (P<0.05). Compared to placebo, total plasma ghrelin was also reduced by 42+/-8 pg/ml (P<0.001) after AX consumption with no difference in plasma acylated ghrelin. CONCLUSION: AX consumption improved postprandial metabolic responses after an LMCT in subjects with IGT and reduced total ghrelin response. However, acylated ghrelin responses were unchanged, suggesting that the acylated ghrelin-mediated orexigenic regulation is not improved as only total plasma ghrelin decreased.

Arabinoxylan fibre consumption improved glucose metabolism, but did not affect serum adipokines in subjects with impaired glucose tolerance.

The consumption of arabinoxylan, a soluble fibre fraction, has been shown to improve glycemic control in type 2 diabetic subjects. Soluble dietary fibre may modulate gastrointestinal or adipose tissue hormones regulating food intake. The present study investigated the effects of arabinoxylan consumption on serum glucose, insulin, lipids, leptin, adiponectin and resistin in subjects with impaired glucose tolerance. In a randomized, single-blind, controlled, crossover intervention trial, 11 adults consumed white bread rolls as either placebo or supplemented with 15 g arabinoxylan for 6 weeks with a 6-week washout period. Fasting serum glucose, insulin, triglycerides, unesterified fatty acids, apolipoprotein A1 and B, adiponectin, resistin and leptin were assessed before and after intervention. Fasting serum glucose, serum triglycerides and apolipoprotein A-1 were significantly lower during arabinoxylan consumption compared to placebo (p=0.029, p=0.047; p=0.029, respectively). No effects of arabinoxylan were observed for insulin, adiponectin, leptin and resistin as well as for apolipoprotein B, and unesterified fatty acids. In conclusion, the consumption of AX in subjects with impaired glucose tolerance improved fasting serum glucose, and triglycerides. However, this beneficial effect was not accompanied by changes in fasting adipokine concentrations.

Soy-isoflavone-enriched foods and markers of lipid and glucose metabolism in postmenopausal women: interactions with genotype and equol production.

BACKGROUND: The hypocholesterolemic effects of soy foods are well established, and it has been suggested that isoflavones are responsible for this effect. However, beneficial effects of isolated isoflavones on lipid biomarkers of cardiovascular disease risk have not yet been shown. OBJECTIVE: The objective was to investigate the effects of isolated soy isoflavones on metabolic biomarkers of cardiovascular disease risk, including plasma total, HDL, and LDL cholesterol; triacylglycerols; lipoprotein(a); the percentage of small dense LDL; glucose; nonesterified fatty acids; insulin; and the homeostasis model assessment of insulin resistance. Differences with respect to single nucleotide polymorphisms in selected genes [ie, estrogen receptor alpha (XbaI and PvuII), estrogen receptor beta (AluI), and estrogen receptor beta(cx) (Tsp509I), endothelial nitric oxide synthase (Glu298Asp), apolipoprotein E (Apo E2, E3, and E4), cholesteryl ester transfer protein (TaqIB), and leptin receptor (Gln223Arg)] and with respect to equol production were investigated. DESIGN: Healthy postmenopausal women (n = 117) participated in a randomized, double-blind, placebo-controlled, crossover dietary intervention trial. Isoflavone-enriched (genistein-to-daidzein ratio of 2:1; 50 mg/d) or placebo cereal bars were consumed for 8 wk, with a wash-out period of 8 wk before the crossover. RESULTS: Isoflavones did not have a significant beneficial effect on plasma concentrations of lipids, glucose, or insulin. A significant difference between the responses of HDL cholesterol to isoflavones and to placebo was found with estrogen receptor beta(cx) Tsp509I genotype AA, but not GG or GA. CONCLUSIONS: Isoflavone supplementation, when provided in the form and dose used in this study, had no effect on lipid or other metabolic biomarkers of cardiovascular disease risk in postmenopausal women but may increase HDL cholesterol in an estrogen receptor beta gene-polymorphic subgroup.

Increase in serum resistin during weight loss in overweight subjects is related to lipid metabolism.

OBJECTIVE: Human resistin has been stated to influence preadipocyte cell numbers and to stimulate adipocyte triglyceride lipolysis in vivo and in vitro. However, its role in human obesity remains unclear. DESIGN: Cross-sectional study for comparisons of lean and obese subjects, and subsequent longitudinal 4-month weight loss intervention study in obese subjects. SUBJECTS: Healthy subjects, lean (n=20, BMI<25) and overweight (n=43, BMI>or=25). MEASUREMENTS: Serum resistin, body weight, body fat, waist-to-hip ratio, as well as markers of insulin resistance and lipid metabolism at baseline and after 4 months of intervention. RESULTS: Serum resistin was positively correlated to HOMA-IR (partial r=0.288; P=0.055), serum fructosamines (partial r=0.280; P=0.062), serum NEFA (partial r=0.276; P=0.066) and negatively to age (partial r=-0.349; P=0.019) and serum apolipoprotein A-1 (partial r=-0.363; P=0.014). During the intervention, serum resistin increased significantly (P<0.001). The increase was inversely related to changes in waist-to-hip ratio (P=0.025) and positively to serum apolipoprotein B (P=0.011). In males only, the increase in resistin during weight loss was predicted by total serum cholesterol at baseline (r=0.703, P=0.007). No relation was observed between changes in resistin and changes in HOMA-IR. CONCLUSION: The present study indicates an association between serum resistin and markers of abdominal fat distribution as well as the regulation of lipid metabolism. However, human resistin is unlikely to play an independent role in the regulation of glucose metabolism.

Odour and taste sensitivity is associated with body weight and extent of misreporting of body weight.

BACKGROUND: Sensory factors are important determinants of appetite and food choices but little is known about the relationship between body weight and sensory capabilities. OBJECTIVE: To investigate the relationship between measured body weights, misreporting of body weight and sensory capabilities. DESIGN: In a cross-sectional sensory study, body weight was assessed by measured and self-reported body weight in healthy men (n=130) and women (n=181). Sensory capabilities were assessed as odour detection and identification, and detection for salty, sweet, sour and bitter taste. RESULTS: Odour detection, odour identification and taste perception scores were lower in subjects with a BMI >or=28 kg/m(2) than in subjects with a BMI <28 kg/m(2) in the age group <65 years whereas in subjects >or=65 years scores were higher in subjects with a BMI >or=28 kg/m(2) than in subjects with a BMI <28 kg/m(2) (BMI*age group: P=0.015, 0.053 and 0.015, respectively). Independent of age, scores were highest in under reporters of body weight (P=0.008, 0.001 and 0.017). Differences in taste perception could be attributed to sour (P=0.015) and bitter (P=0.026) perception, but not to salty or sweet perception. CONCLUSION: Relationship between sensory capabilities and body mass is age dependent. Compared to overweight subjects, the sensory capabilities of normal weight individuals appear to be higher (<65 years) and lower (>or=65 years). At any age, however, subjects who under reported their body weight show higher sensory capabilities.

Consumption of soy isoflavones does not affect plasma total homocysteine or asymmetric dimethylarginine concentrations in healthy postmenopausal women.

Postmenopausal women are at increased risk for cardiovascular disease because many risk factors are aggravated by menopause. Phytoestrogens may modulate risk factors favorably, involving mechanisms similar to estrogen. The effect of phytoestrogens on the atherogenic amino acids homocysteine and asymmetric dimethylarginine (ADMA) was investigated in a controlled intervention study in healthy postmenopausal women. A multicenter, double-blind, crossover intervention trial in 89 postmenopausal women from Denmark, Germany, and the UK was performed. Subjects consumed fruit cereal bars with or without soy isoflavones (50 mg/d) for 8 wk each with an 8-wk washout period in between. Urinary phytoestrogens increased significantly after isoflavone intervention (P < 0.001). Isoflavone supplementation did not affect plasma total homocysteine or ADMA. For homocysteine, changes from baseline were 0.32 micromol/L (range: -0.31-0.92; 95% CI 0.13-0.72), and 0.29 micromol/L (range: -0.45-1.09; 95% CI 0.01-0.63, P = 0.286) for isoflavone treatment and placebo, respectively. For ADMA concentrations, changes from baseline were -0.02 micromol/L (range: -0.08-0.03; 95% CI -0.04-0.01, and 0.00 micromol/L (range: -0.05-0.03; 95% CI -0.03-0.01, P = 0.397) for isoflavone treatment and placebo, respectively. There was no association between plasma total homocysteine and ADMA. Changes from baseline in plasma ADMA and folate were negatively correlated (r = -0.18, P = 0.017). These results challenge the overall health effect of isoflavone supplementation in healthy postmenopausal women.

Influence of hormone replacement therapy on proteomic pattern in serum of postmenopausal women.

OBJECTIVES: Proteomics approaches to cardiovascular biology and disease hold the promise of identifying specific proteins and peptides or modification thereof to assist in the identification of novel biomarkers. METHOD: By using surface-enhanced laser desorption and ionization time of flight mass spectroscopy (SELDI-TOF-MS) serum peptide and protein patterns were detected enabling to discriminate between postmenopausal women with and without hormone replacement therapy (HRT). RESULTS: Serum of 13 HRT and 27 control subjects was analyzed and 42 peptides and proteins could be tentatively identified based on their molecular weight and binding characteristics on the chip surface. By using decision tree-based Biomarker Patternstrade mark Software classification and regression analysis a discriminatory function was developed allowing to distinguish between HRT women and controls correctly and, thus, yielding a sensitivity of 100% and a specificity of 100%. The results show that peptide and protein patterns have the potential to deliver novel biomarkers as well as pinpointing targets for improved treatment. The biomarkers obtained represent a promising tool to discriminate between HRT users and non-users. CONCLUSION: According to a tentative identification of the markers by their molecular weight and binding characteristics, most of them appear to be part of the inflammation induced acute-phase response.

An easy-to-use semiquantitative food record validated for energy intake by using doubly labelled water technique.

BACKGROUND: Estimating dietary intake is important for both epidemiological and clinical studies, but often lacks accuracy. OBJECTIVE: To investigate the accuracy and validity of energy intake estimated by an easy-to-use semiquantitative food record (EI(SQFR)) compared to total energy expenditure (TEE) estimated by doubly labelled water technique (EE(DLW)). DESIGN: TEE was measured in 29 nonobese subjects using the doubly labelled water method over a period of 14 days. Within this period, subjects reported their food consumption by a newly developed semiquantitative food record for 4 consecutive days. Energy intake was calculated using the German Food Code and Nutrition Data Base BLS II.3. RESULTS: A good correlation was observed between EI(SQFR) and EE(DLW) (r = 0.685, P < 0.001). The mean difference between EI(SQFR) and EE(DLW) was -1.7+/-2.6 MJ/day (-14+/-21%, P = 0.002). An underestimation of EI(SQFR) <10% was observed in nine subjects (31%), of 10-20% in six subjects (21%), and of >20% in nine subjects (31%). In five subjects (17%), an overestimation of EI(SQFR) was observed. CONCLUSIONS: The easy-to-use semiquantitative food record provided good estimates of EI in free-living and nonobese adults without prior detailed verbal instructions. The presented food record has limitations regarding accuracy at the individual level.

Arabinoxylan-enriched meal increases serum ghrelin levels in healthy humans.

Soluble fibre like arabinoxylan (AX) is thought to have beneficial effects on metabolism. In this study, we investigated the effect of a breakfast enriched in AX fibre on glucose, insulin and ghrelin values. AX-enriched and control breakfasts were served to fifteen young volunteers (nine female, six male). Glucose, insulin and ghrelin responses were measured after the meal. To avoid effects from differences in glucose metabolism, further analysis was restricted to those subjects with known normal glucose regulation (seven female, four male). The AX fibre-enriched breakfast did not significantly change glucose levels for two hours after breakfast, but decreased insulin levels in the entire cohort (p = 0.035). Glucose response was also not significantly different in subjects with normal glucose regulation (p = 0.367), and the insulin responses after an AX-enriched breakfast showed only a tendency towards lower values (p = 0.065). Nevertheless, plasma ghrelin two hours after AX-enriched breakfast was higher than after the control meal (396.1 +/- 36.4 pg/ml vs. 328.3 +/- 32.6 pg/ml, p < 0.001). In subjects with normal glucose regulation, the AX-enriched breakfast increased ghrelin levels without any significant difference in glucose or insulin response. This effect is therefore unlikely to be mediated by insulin, but the underlying mechanism remains to be elucidated.

Validation of a simplified physical activity record by doubly labeled water technique.

INTRODUCTION: For obtaining reliable information about physical activity in epidemiological studies, validated and easy-to-use instruments are required. Therefore, a new simplified physical activity record based on 15-min recording intervals was developed and validated. SUBJECTS: Nonobese volunteers (n = 31). MEASUREMENTS: Physical activity was recorded over a 7-day period without detailed instructions. Energy expenditure was calculated (EE(sPAR)) and compared to energy expenditure measured by doubly labelled water technique (EE(DLW)). RESULTS: A good agreement between EE(sPAR) (12.1+/-3.0) and EE(DLW) (11.7+/-3.3) with a mean difference of 0.33+/-1.55 MJ (r = 0.880, P < 0.001) was observed. The absolute difference between EE(sPAR) and EE(DLW) was < 10% in 65% of the subjects. The difference between EE(sPAR) and EE(DLW) was independent of gender, age, body weight, and body mass index. A weak positive association between the difference and total body fat was observed (r = 0.618, P < 0.001), suggesting a slight tendency to overestimate EE(sPAR) with increasing total body fat. CONCLUSION: The new simplified physical activity protocol needs no detailed instructions, provides valid estimates of physical activity in nonobese free-living adults and can be used in epidemiological studies to assess total daily energy expenditure and physical activity level.

The acceptability of isoflavones as a treatment of menopausal symptoms: a European survey among postmenopausal women.

OBJECTIVE: To investigate determinants of the acceptability of isoflavone products among postmenopausal women with regard to social and lifestyle factors, dietary habits, health concerns, food beliefs, menopausal symptoms and therapies, and to elucidate preferences for specific products. METHODS: A consumer survey was conducted among postmenopausal women in four European countries (Germany, Denmark, Italy and the UK), including a total of 465 respondents. RESULTS: The declared acceptability of isoflavones was highest in Germany (80%), followed by Italy (75%), the UK (59%) and Denmark (55%; p < 0.001). Among other factors, prior information about isoflavones (odds ratio (OR) 2.64, 95% confidence interval (CI) 1.54-4.51, p < 0.001) and belief that foods can be used to treat medical conditions (OR 2.18, 95% CI 1.17-4.05, p = 0.014) were the strongest predictors of potential acceptability. The preferred forms in which isoflavones might be taken differed markedly between countries. CONCLUSIONS: Information about the health effects of isoflavones and health-diet links should be considered the most important factors in attempts to influence the potential acceptability of isoflavone products. Foods enriched with isoflavones need to be developed with regard to specific cultural demands in order to assure consumer acceptance on the marketplace.

Double-blind, randomized feedback control fails to improve the hypocholesterolemic effect of a plant-based low-fat diet in patients with moderately elevated total cholesterol levels.

OBJECTIVE: To determine whether the cholesterol-lowering effect of a plant-based low-fat diet can be improved by a flexible control design that controls the extent of fat reduction based on the individual response of blood cholesterol. DESIGN: Randomized, double-blind intervention study. SETTING: A hotel in Prerow, Germany. SUBJECTS: A total of 32 participants (21 female and 11 male participants) with total cholesterol level > 5.7 mmol/l. INTERVENTION: The control group consumed a plant-based low-fat diet with constantly 20% of energy as fat; the intervention group received a diet with either 20 or 15% of energy as fat, depending on the serum cholesterol response of the preceding week. A flexible control design based on the individual cholesterol response during a run-in period of 1 week was used within a low-fat intervention. RESULTS: During the run-in period, the consumption of a plant-based low-fat diet led to a reduction in total cholesterol by 18+/-6 mmol/l (P < 0.001), in LDL cholesterol by 19+/-9 mmol/l (P < 0.001) and triglycerides by 13+/-3 mmol/l (P < 0.001). During the feedback control period, an additional reduction in total cholesterol by 13+/-8 (P < 0.001) and in LDL cholesterol by 17+/-11 (P < 0.001) was observed compared to 15+/-15 and 7+/-18 in the control group. The effect of an additional feedback control was only marginal and not statistically significant compared to the effect of the low-fat diet alone. CONCLUSIONS: On a level of fat intake already reduced to 20% of energy, the use of a feedback control to adapt the fat content of the diet depending on the individual serum cholesterol response was not more effective in reducing blood cholesterol levels than a plant-based low-fat diet alone.

Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation.

BACKGROUND: The aim of the present study was to investigate the effect of a probiotic beverage on gastrointestinal symptoms in patients with chronic constipation. METHODS: A double-blind, placebo-controlled, randomized study was conducted over a four-week period in patients with symptoms of chronic constipation (n=70). To all patients, 65 mL/day of a probiotic beverage containing Lactobacillus casei Shirota (LcS) or a sensorially identical placebo was administered. Patients completed a questionnaire on gastrointestinal symptoms, well-being and stool habits and underwent a medical examination weekly. Severity of constipation, flatulence and bloating was summarized into four categories (severe, moderately severe, mild and no symptoms). RESULTS: The consumption of LcS resulted in a significant improvement in self-reported severity of constipation and stool consistency, starting in the second week of the intervention phase (P<0.0001). Severe and moderately severe constipation was observed less in the LcS group. The occurrence and degree of flatulence or bloating sensation did not change. In the final examination, 89% of the LcS group and 56% of the placebo group showed a positive effect of their beverage on constipation (P=0.003). No adverse reactions were reported. CONCLUSIONS: The results indicate a beneficial effect on gastrointestinal symptoms of patients with chronic constipation. The administration of probiotic foodstuffs may be recommended as an adjunctive therapy of chronic constipation.

Carob pulp preparation rich in insoluble fibre lowers total and LDL cholesterol in hypercholesterolemic patients.

BACKGROUND: Recently, insoluble fibre from carob pulp has been found to affect blood lipids in animals in a similar manner as soluble dietary fibre. AIM OF THE STUDY: To investigate whether a carob pulp preparation containing high amounts of insoluble fibre has a beneficial effect on serum cholesterol in humans. METHODS: Volunteers (n = 58) with hypercholesterolemia were recruited to participate in a randomised, double- blind, placebo-controlled and parallel arm clinical study with a 6 week intervention phase. All participants consumed daily both, bread (two servings) and a fruitbar (one serving) either with (n = 29) or without (n = 29) a total amount of 15 g/d of a carob pulp preparation (carob fibre). Serum concentrations of total, LDL and HDL cholesterol and triglycerides were assessed at baseline and after week 4 and 6. RESULTS: The consumption of carob fibre reduced LDL cholesterol by 10.5 +/- 2.2% (p = 0.010). The LDL:HDL cholesterol ratio was marginally decreased by 7.9 +/- 2.2 % in the carob fibre group compared to the placebo group (p = 0.058). Carob fibre consumption also lowered triglycerides in females by 11.3 +/- 4.5% (p = 0.030). Lipid lowering effects were more pronounced in females than in males. CONCLUSION: Daily consumption of food products enriched with carob fibre shows beneficial effects on human blood lipid profile and may be effective in prevention and treatment of hypercholesterolemia.

Carob pulp preparation for treatment of hypercholesterolemia.

The lipid-lowering effect of a carob pulp preparation rich in insoluble dietary fiber and polyphenols was investigated in a noncomparative, open-label pilot study. Over 8 weeks, 47 volunteers with moderate hypercholesterolemia (total cholesterol 232-302 mg/dL) consumed 15 g of carob per day in three products (breakfast cereal, fruit muesli bar, powdered drink) as a supplement to their regular diet. After 4 weeks, reductions of 7.1% in mean total cholesterol and 10.6% in LDL cholesterol were noted; respective decreases after 6 weeks were 7.8% and 12.2% (all P<.001). HDL cholesterol and triglyceride levels remained unchanged. Overall compliance was good. Only 3 volunteers (6%) reported a sensation of fullness, which led to 2 of the 3 dropouts. The carob preparation may have value in the dietary treatment of hypercholesterolemia.

Randomized controlled trial of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates on body weight and blood lipids: the CARMEN study. The Carbohydrate Ratio Management in European National diets.

OBJECTIVE: To investigate the long-term effects of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates. DESIGN: Randomized controlled multicentre trial (CARMEN), in which subjects were allocated for 6 months either to a seasonal control group (no intervention) or to one of three experimental groups: a control diet group (dietary intervention typical of the average national intake); a low-fat high simple carbohydrate group; or a low-fat high complex carbohydrate group. SUBJECTS: Three hundred and ninety eight moderately obese adults. MEASUREMENTS: The change in body weight was the primary outcome; changes in body composition and blood lipids were secondary outcomes. RESULTS: Body weight loss in the low-fat high simple carbohydrate and low-fat high complex carbohydrate groups was 0.9 kg (P < 0.05) and 1.8 kg (P < 0.001), while the control diet and seasonal control groups gained weight (0.8 and 0.1 kg, NS). Fat mass changed by -1.3kg (P< 0.01), -1.8kg (P< 0.001) and +0.6kg (NS) in the low-fat high simple carbohydrate, low-fat high complex carbohydrate and control diet groups, respectively. Changes in blood lipids did not differ significantly between the dietary treatment groups. CONCLUSION: Our findings suggest that reduction of fat intake results in a modest but significant reduction in body weight and body fatness. The concomitant increase in either simple or complex carbohydrates did not indicate significant differences in weight change. No adverse effects on blood lipids were observed. These findings underline the importance of this dietary change and its potential impact on the public health implications of obesity.