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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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ClinicalTrials.gov Identifier: NCT02228746
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : August 29, 2014
Sponsor:
Collaborator:
Institute of Cardiometabolism and Nutrition, France
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Randomized Versus Placebo Controlled Double Blind Dietary Supplement: Alpha-galacto-oligosaccharides Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alpha-galacto-oliosaccharides Dietary Supplement: Alpha-galacto-oligosaccharides
6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink

Placebo Comparator: Placebo



Primary Outcome Measures :
  1. Body weight (kg) between day 0 and week 12 [ Time Frame: Day 0, Day 7, Month 1, Month 2, Month 3 ]

Secondary Outcome Measures :
  1. 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

  2. Lean body mass [ Time Frame: Between day 0 and week 12 ]
  3. Waist circumference [ Time Frame: Day 0, day 7, Month1, Month 2, Month 3 ]
  4. Hip circumference [ Time Frame: Day 0, Day 7, Month 1, Month 2, Month 3 ]
  5. Waist to hip circumference ratio [ Time Frame: Between Day 0 and week 12 ]
  6. Body Fat [ Time Frame: Day 7, Month 3 ]

Other Outcome Measures:
  1. Body Mass Index (BMI) [ Time Frame: between Day 0 and week 12 ]
  2. arterial systolic and diastolic pressures [ Time Frame: between day 0 and week 12 ]
  3. 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

  4. Components of the intestinal commensal microbiota [ Time Frame: between day 0 and week 12 ]
  5. Lipid Profile [ Time Frame: Day 0, Week 12 ]
  6. Markers of systemic inflammation [ Time Frame: Day 0, Week 12 ]
  7. Glycemic profile [ Time Frame: Day 0, Week 12 ]
  8. Circulating adipokines [ Time Frame: Day 0, Week 12 ]
  9. Hemostatic factors associated with cardiovascular risks [ Time Frame: Day 0, Week 12 ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228746


Locations
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France
Centre d'Investigation Clinique Paris-Est/ Bâtiment Antonin Gosset Hôpital de la Pitié Salpêtrière- 56 Boulevard Vincent Auriol
Paris, France, 75013
Sponsors and Collaborators
Olygose
Institute of Cardiometabolism and Nutrition, France

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Responsible Party: Olygose
ClinicalTrials.gov Identifier: NCT02228746     History of Changes
Other Study ID Numbers: 2012-A01610--43
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: August 29, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Overweight
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes