Effects of a 3-month supplementation with a novel soluble highly viscous polysaccharide on anthropometry and blood lipids in nondieting overweight or obese adults.

BACKGROUND: High viscosity fibre is known to exert many beneficial effects on appetite and metabolism. It could potentially help in weight management, in dieting or nondieting individuals. The present study investigated the effects of the daily intake of a novel high viscosity polysaccharide (HVP) over 3 months in nondieting obese or overweight men and women. METHODS: The study comprised a double-blind, randomised controlled clinical trial. Participants ingested 5-15 g per day of either HVP (n = 29, experimental group) or inulin (n = 30, control group) for 15 weeks. Changes in anthropometry (weight, waist and hip circumferences), blood lipids and glucose tolerance were studied from the beginning to the end of administration. Compliance and tolerance were examined. RESULTS: Differences appeared between HVP and inulin supplementation in female participants only. Mean (SD) decreases in body weight [1.6 (3.2) kg; approximately 2% of initial weight] and hip circumference [2.8 (3.6 ) cm] occurred in women of the HVP group but not in controls (Time × Group interactions, P ≤ 0.002). Total, high-density lipoprotein and low-density lipoprotein-cholesterol were lower at the end of supplementation in the women of the HVP group compared to controls (P ≤ 0.021). No effect appeared in waist circumference and triacylglycerol. No difference was noted in the number or severity of the adverse effects reported in both groups. Adverse effects were mild and agreed with commonly reported reactions to intake of dietary fibre. CONCLUSIONS: Beneficial although modest effects appeared after several weeks of daily HVP intake in nondieting obese or overweight women. The effects of HVP should be investigated in the context of a weight loss programme.

Evaluation of Levothyroxine Bioavailability after Oral Administration of a Fixed Combination of Soy Isoflavones in Post-menopausal Female Volunteers.

BACKGROUND: Post-menopausal women under treatment with levothyroxine for their medical conditions may take concomitantly dietary supplements containing soy isoflavones in combination to treat their post-menopausal symptoms. The aim of this study was to investigate the effect of a fixed combination of soy isoflavones on the oral bioavailability of levothyroxine in post-menopausal female volunteers. METHODS: 12 healthy post-menopausal female, who were on stable oral levothyroxine as replacement/supplementation therapy for hypothyroidism, received a single recommended oral dose of a food supplement containing 60 mg of soy isoflavones (>19% genistin and daidzin) concomitantly with (test) and 6 h later (reference) the administration of levothyroxine in a randomized, open label, crossover fashion. Plasma concentrations of levothyroxine and soy isoflavones (daidzin, daidzein, genistin, genistein, S-equol) were determined by LC-MS/MS. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis. No effect of soy isoflavones was assumed if the 90% confidence intervals (CIs) for the estimated ratio test/reference was included in the acceptance limits 0.80-1.25 for PK parameters Cmax and AUCt. RESULTS: The test/reference ratios Cmax and AUCt of levothyroxine were very close to unity (1.02 and 0.99, respectively) and the corresponding 90% CIs (0.99-1.04 and 0.88-1.12, respectively) fell entirely within the acceptance bioequivalence limits. CONCLUSION: The combination of soy isoflavones used in the present investigation does not affect the rate and extent of levothyroxine absorption when administered concomitantly in post-menopausal women.

Hydrogen excretion upon ingestion of dairy products in lactose-intolerant male subjects: importance of the live flora.

OBJECTIVE: To assess the effects of the ingestion of milk, yoghurt (10(8) bacteria/ml), heat-treated yoghurt (<15 bacteria/ml) and two products obtained by dilution of yoghurt with heat-treated product (10(6) and 10(5) bacteria/ml) on hydrogen production and symptoms of lactose intolerance in lactose malabsorbers. DESIGN: Double-blind, randomised cross-over design. SETTING: The study was performed in the phase 1 clinical unit of OPTIMED, Nancy, France. SUBJECTS: Twenty-four male lactose malabsorbers were selected for the study. INTERVENTIONS: Hydrogen production and adverse events were followed during 8 h after ingestion of the products. RESULTS: The results clearly demonstrate that ingestion of yoghurt with 10(8) bacteria/ml leads to lower H(2) excretion and complaints than the other products. Results observed with the products containing a reduced population of live flora remain better than those observed with milk. CONCLUSIONS: The importance of a high population of the live flora is underlined.

[Effect of low-dose polyethylene glycol 4000 on fecal consistency and dilution water in healthy subjects]. / Effet du polyéthylène glycol 4000 à petites doses sur la consistance et l'eau de dilution des selles chez le sujet sain.

OBJECTIVES: The aim of the study was to assess in normal subjects the changes in stool consistency and dilution water during the ingestion of small doses of polyethylene glycol (PEG) 5.9 g/d. Dilution water is the water located outside solid structures (bacteria and food residue). METHODS: Each stool passed by 16 non-constipated male volunteers was collected during 3 weeks. PEG was ingested from days 1 to 7, and stools collected during the ingestion of PEG were compared with those collected at least 24 h after the last fecal excretion of PEG (control fecal data). Consistency, fresh and dry weight, dilution water, nitrogen, electrolytes and PEG were quantified in each stool. RESULTS: Stools were softer during the ingestion of PEG (P < 0.01) and dilution water increased significantly (49.4 +/- 1.7 vs 37.6 +/- 2.6 mL/100 g feces, mean +/- SD, P < 0.02). PEG induced variable effects among individuals according to the consistency and dilution water measured during the control period. CONCLUSION: Low doses of PEG (5.9 g/d) soften stools particularly when feces are harder. This effect is due to changes in dilution water (water outside fecal solid structures).

Estradiol pharmacokinetics after transdermal application of patches to postmenopausal women: matrix versus reservoir patches.

OBJECTIVE: A new matrix 17 beta-estradiol transdermal patch incorporating lauric acid to improve estradiol skin absorption has been designed for hormone replacement therapy. Estradiol pharmacokinetics obtained with the prototype, its industrial counterpart, a matrix-type, System 50, and a reservoir-type, Estraderm TTS 50, transdermal patch have been compared. Each device delivers 50 micrograms estradiol daily. METHODS: Twenty postmenopausal women received each of the four formulations for 3 days in a Latin-square design and with a minimum 4-day wash-out period between treatments. Estradiol plasma concentrations were measured by radioimmunoassay at 6, 12, 24, 48 and 72 h after application. RESULTS: The prototype patch and its industrial counterpart showed no significant difference in estradiol delivery, with 72-h systemic exposure to estradiol similar to that of the reservoir patch but greater than that of the reference matrix formulation, with average baseline-corrected concentrations (SEM) of 35 (4), 32 (3), 32 (2) and 19 (1.8) pg/ml, respectively. In addition, they ensured more stable delivery, with coefficients of variation of plasma estradiol concentrations (12-72 h) of 29, 41, 63 and 84%, respectively. All matrix patches demonstrated the same patients to be poor estradiol absorbers, different from those encountered with the reservoir patch type, despite an improved estradiol bioavailability with the lauric acid-containing matrix patch. CONCLUSION: Matrix patches incorporating lauric acid led to estradiol plasma levels more stable than with the reference matrix and reservoir patches, and greater than those with the reference matrix patch.