Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo

Olygose100 enrolled

Overview

Clinical intervention on overweight or moderately obeses adults. The objective of this trial is to demonstrate the superior eficacy of Alphagos to placebo on weight loss during a low-calorie diet of 12 weeks. The superiority is judged on body weight. Change in cardiometabolic risk factors through the intervention have been evaluated as secondary endpoints

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Randomized Versus Placebo Controlled Double Blind

Interventions

Alpha-galacto-oligosaccharidesDIETARY_SUPPLEMENT

6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body Mass Index \> or equal 25 and \< 35 * Use of effective contraception in women of childbearing age Exclusion Criteria: * Pregnant women (positive pregnancy test) or breastfeeding * Anti-hypertensive or cholesterol treatment * HIV infection or HCV * Hepatic and/or severe renal failure * Heart attack within 6 months prior the selection * Heart failure known * Inflammatory disease known * Cancer or have had cancer within 3 years prior to the study except for basal cell skin cancers * Diabetes defined by blood glucose greater than or equal to 1.26 g/L * Gastrointestinal disease known * Bariatric surgery

Locations (1)

Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol

Paris, France

Outcomes

Primary Outcomes

Body weight (kg) between day 0 and week 12

Time frame: Day 0, Day 7, Month 1, Month 2, Month 3

Secondary Outcomes

Feeding behaviour

Changes in feeding behaviour will be studied by : * visual analogue scales rating for hunger, satiety, fullness, desire to eat, prospective consumption during preload-test meal paradigm (standardized breakfast and lunch test) * level of circulating peptides involved in the regulation of controlling food intake during a kinetic after a standardized breakfast (samples 30, 60, 120, 180 and 240 min after the start of standardized breakfast) * food intake during the lunch test

Time frame: Between day 0 and week 12

Lean body mass

Time frame: Between day 0 and week 12

Waist circumference

Time frame: Day 0, day 7, Month1, Month 2, Month 3

Hip circumference

Time frame: Day 0, Day 7, Month 1, Month 2, Month 3

Waist to hip circumference ratio

Time frame: Between Day 0 and week 12

Body Fat

Time frame: Day 7, Month 3

Data from ClinicalTrials.gov

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