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Completed

NCT Number: NCT02228746

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

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

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Key information

Conditions

Randomized Versus Placebo Controlled Double Blind

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alpha-galacto-oligosaccharides

Dietary Supplement

6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink

Primary outcomes

  1. Body weight (kg) between day 0 and week 12

    Time frame: Day 0, Day 7, Month 1, Month 2, Month 3

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Olygose

Industry

Collaborators

  • Institute of Cardiometabolism and Nutrition, France

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2014
Registry last updated
Aug 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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