Controlled, Double Blind, Randomized Versus Placebo
Conditions
Brief summary
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
Interventions
DIETARY_SUPPLEMENTAlpha-galacto-oligosaccharides
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
Sponsors
Institute of Cardiometabolism and Nutrition, France
Olygose
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight (kg) between day 0 and week 12 | Day 0, Day 7, Month 1, Month 2, Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean body mass | Between day 0 and week 12 | — |
| Waist circumference | Day 0, day 7, Month1, Month 2, Month 3 | — |
| Feeding behaviour | Between day 0 and week 12 | 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 |
| Waist to hip circumference ratio | Between Day 0 and week 12 | — |
| Body Fat | Day 7, Month 3 | — |
| Hip circumference | Day 0, Day 7, Month 1, Month 2, Month 3 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Circulating adipokines | Day 0, Week 12 | — |
| Body Mass Index (BMI) | between Day 0 and week 12 | — |
| Hemostatic factors associated with cardiovascular risks | Day 0, Week 12 | — |
| arterial systolic and diastolic pressures | between day 0 and week 12 | — |
| Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region | between day 0 and week 12 | Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism |
| Components of the intestinal commensal microbiota | between day 0 and week 12 | — |
| Lipid Profile | Day 0, Week 12 | — |
| Markers of systemic inflammation | Day 0, Week 12 | — |
| Glycemic profile | Day 0, Week 12 | — |
Countries
France
Outcome results
None listed