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

August 28, 2014 updated by: Olygose
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75013
        • Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Experimental: Alpha-galacto-oliosaccharides
Dietary supplement: Alpha-galacto-oligosaccharides
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight (kg) between day 0 and week 12
Time Frame: Day 0, Day 7, Month 1, Month 2, Month 3
Day 0, Day 7, Month 1, Month 2, Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feeding behaviour
Time Frame: 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
Between day 0 and week 12
Lean body mass
Time Frame: Between day 0 and week 12
Between day 0 and week 12
Waist circumference
Time Frame: Day 0, day 7, Month1, Month 2, Month 3
Day 0, day 7, Month1, Month 2, Month 3
Hip circumference
Time Frame: Day 0, Day 7, Month 1, Month 2, Month 3
Day 0, Day 7, Month 1, Month 2, Month 3
Waist to hip circumference ratio
Time Frame: Between Day 0 and week 12
Between Day 0 and week 12
Body Fat
Time Frame: Day 7, Month 3
Day 7, Month 3

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: between Day 0 and week 12
between Day 0 and week 12
arterial systolic and diastolic pressures
Time Frame: between day 0 and week 12
between day 0 and week 12
Morphological, inflammatory and metabolic characteristics of adipose tissue sampled from the abdominal region
Time Frame: 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
between day 0 and week 12
Components of the intestinal commensal microbiota
Time Frame: between day 0 and week 12
between day 0 and week 12
Lipid Profile
Time Frame: Day 0, Week 12
Day 0, Week 12
Markers of systemic inflammation
Time Frame: Day 0, Week 12
Day 0, Week 12
Glycemic profile
Time Frame: Day 0, Week 12
Day 0, Week 12
Circulating adipokines
Time Frame: Day 0, Week 12
Day 0, Week 12
Hemostatic factors associated with cardiovascular risks
Time Frame: Day 0, Week 12
Day 0, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olygose

Collaborators

Institute of Cardiometabolism and Nutrition, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

August 29, 2014

Last Update Submitted That Met QC Criteria

August 28, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01610--43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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