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

Not Applicable

Completed

• Conditions: Randomized Versus Placebo; Controlled; Double Blind

• Registration Number: NCT02228746
• Lead Sponsor: Olygose

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-28
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted QC: 2014-08-28
• Last Update Submitted: 2014-08-28
• Study First Posted: 2014-08-29
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body weight (kg) between day 0 and week 12	Day 0, Day 7, Month 1, Month 2, Month 3

Secondary Outcome Measures

Name	Time	Method
Hip circumference	Day 0, Day 7, Month 1, 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
Lean body mass	Between day 0 and week 12
Waist circumference	Day 0, day 7, Month1, Month 2, Month 3
Waist to hip circumference ratio	Between Day 0 and week 12
Body Fat	Day 7, Month 3

Trial Locations

Locations (1)

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