Controlled Clinical Trial
Official title:
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
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
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 20 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Olygose | Institute of Cardiometabolism and Nutrition, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Body Mass Index (BMI) | between Day 0 and week 12 | Yes | |
| Other | arterial systolic and diastolic pressures | between day 0 and week 12 | Yes | |
| Other | Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region | Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism | between day 0 and week 12 | Yes |
| Other | Components of the intestinal commensal microbiota | between day 0 and week 12 | Yes | |
| Other | Lipid Profile | Day 0, Week 12 | Yes | |
| Other | Markers of systemic inflammation | Day 0, Week 12 | Yes | |
| Other | Glycemic profile | Day 0, Week 12 | Yes | |
| Other | Circulating adipokines | Day 0, Week 12 | Yes | |
| Other | Hemostatic factors associated with cardiovascular risks | Day 0, Week 12 | Yes | |
| Primary | Body weight (kg) between day 0 and week 12 | Day 0, Day 7, Month 1, Month 2, Month 3 | Yes | |
| Secondary | 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 | Yes |
| Secondary | Lean body mass | Between day 0 and week 12 | Yes | |
| Secondary | Waist circumference | Day 0, day 7, Month1, Month 2, Month 3 | Yes | |
| Secondary | Hip circumference | Day 0, Day 7, Month 1, Month 2, Month 3 | Yes | |
| Secondary | Waist to hip circumference ratio | Between Day 0 and week 12 | Yes | |
| Secondary | Body Fat | Day 7, Month 3 | Yes |