Clinical trial NCT02228746: Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Randomized Versus Placebo
Controlled
Double Blind
Lead sponsor: Olygose
Sponsor class: INDUSTRY
Collaborators: name: Institute of Cardiometabolism and Nutrition, France
First posted: 2014-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kg) between day 0 and week 12
timeFrame: Day 0, Day 7, Month 1, Month 2, Month 3
Secondary outcomes:
measure: Feeding behaviour
timeFrame: Between day 0 and week 12
measure: Lean body mass
timeFrame: Between day 0 and week 12
measure: Waist circumference
timeFrame: Day 0, day 7, Month1, Month 2, Month 3
measure: Hip circumference
timeFrame: Day 0, Day 7, Month 1, Month 2, Month 3
measure: Waist to hip circumference ratio
timeFrame: Between Day 0 and week 12
measure: Body Fat
timeFrame: Day 7, Month 3
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: between Day 0 and week 12
measure: arterial systolic and diastolic pressures
timeFrame: between day 0 and week 12
measure: Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region
timeFrame: between day 0 and week 12
measure: Components of the intestinal commensal microbiota
timeFrame: between day 0 and week 12
measure: Lipid Profile
timeFrame: Day 0, Week 12
measure: Markers of systemic inflammation
timeFrame: Day 0, Week 12
measure: Glycemic profile
timeFrame: Day 0, Week 12
measure: Circulating adipokines
timeFrame: Day 0, Week 12
measure: Hemostatic factors associated with cardiovascular risks
timeFrame: Day 0, Week 12
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
Study officials:
References: