Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
Primary Purpose
Randomized Versus Placebo, Controlled, Double Blind
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Alpha-galacto-oligosaccharides
Sponsored by
About this trial
This is an interventional treatment trial for Randomized Versus Placebo
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
Sites / Locations
- Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Alpha-galacto-oliosaccharides
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Body weight (kg) between day 0 and week 12
Secondary Outcome Measures
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
Lean body mass
Waist circumference
Hip circumference
Waist to hip circumference ratio
Body Fat
Full Information
NCT ID
NCT02228746
First Posted
April 28, 2014
Last Updated
August 28, 2014
Sponsor
Olygose
Collaborators
Institute of Cardiometabolism and Nutrition, France
1. Study Identification
Unique Protocol Identification Number
NCT02228746
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olygose
Collaborators
Institute of Cardiometabolism and Nutrition, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Randomized Versus Placebo, Controlled, Double Blind
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alpha-galacto-oliosaccharides
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha-galacto-oligosaccharides
Intervention Description
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
Primary Outcome Measure Information:
Title
Body weight (kg) between day 0 and week 12
Time Frame
Day 0, Day 7, Month 1, Month 2, Month 3
Secondary Outcome Measure Information:
Title
Feeding behaviour
Description
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
Time Frame
Between day 0 and week 12
Title
Lean body mass
Time Frame
Between day 0 and week 12
Title
Waist circumference
Time Frame
Day 0, day 7, Month1, Month 2, Month 3
Title
Hip circumference
Time Frame
Day 0, Day 7, Month 1, Month 2, Month 3
Title
Waist to hip circumference ratio
Time Frame
Between Day 0 and week 12
Title
Body Fat
Time Frame
Day 7, Month 3
Other Pre-specified Outcome Measures:
Title
Body Mass Index (BMI)
Time Frame
between Day 0 and week 12
Title
arterial systolic and diastolic pressures
Time Frame
between day 0 and week 12
Title
Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region
Description
Adipocyte size and diameter, secretion profile of subcutaneous adipose tissue, gene expression profile of adipose tissue, lipolytic response and energy metabolism
Time Frame
between day 0 and week 12
Title
Components of the intestinal commensal microbiota
Time Frame
between day 0 and week 12
Title
Lipid Profile
Time Frame
Day 0, Week 12
Title
Markers of systemic inflammation
Time Frame
Day 0, Week 12
Title
Glycemic profile
Time Frame
Day 0, Week 12
Title
Circulating adipokines
Time Frame
Day 0, Week 12
Title
Hemostatic factors associated with cardiovascular risks
Time Frame
Day 0, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Learn more about this trial
Effect of the Alpha-galacto-oligasaccharides on Weight Loss in Overweight or Moderately Obeses Adults : A Randomized Controlled Double Blinded Trial Versus Placebo
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