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

Study Overview
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Brief Summary
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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

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

Conditions
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Randomized Versus Placebo, Controlled, Double Blind

Intervention / Treatment
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* Dietary Supplement: Alpha-galacto-oligosaccharides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpha-galacto-oliosaccharides<br> | Dietary Supplement: Alpha-galacto-oligosaccharides<br>* 6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink<br>|
| Placebo Comparator: Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight (kg) between day 0 and week 12 |  | Day 0, Day 7, Month 1, Month 2, Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Between day 0 and week 12 | 
| Lean body mass |  | Between day 0 and week 12 | 
| Waist circumference |  | Day 0, day 7, Month1, Month 2, Month 3 | 
| Hip circumference |  | Day 0, Day 7, Month 1, Month 2, Month 3 | 
| Waist to hip circumference ratio |  | Between Day 0 and week 12 | 
| Body Fat |  | Day 7, Month 3 |