Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
1 other identifier
interventional
100
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 29, 2014
CompletedAugust 29, 2014
August 1, 2014
11 months
April 28, 2014
August 28, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Body weight (kg) between day 0 and week 12
Day 0, Day 7, Month 1, Month 2, Month 3
Secondary Outcomes (6)
Feeding behaviour
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
- +1 more secondary outcomes
Other Outcomes (9)
Body Mass Index (BMI)
between Day 0 and 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
- +6 more other outcomes
Study Arms (2)
Alpha-galacto-oliosaccharides
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
Eligibility Criteria
You may qualify if:
- Body Mass Index \> or equal 25 and \< 35
- Use of effective contraception in women of childbearing age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olygoselead
- Institute of Cardiometabolism and Nutrition, Francecollaborator
Study Sites (1)
Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
Paris, 75013, France
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2014
First Posted
August 29, 2014
Study Start
September 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
August 29, 2014
Record last verified: 2014-08