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

NCT ID: NCT02228746

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Randomized Versus Placebo Controlled Double Blind

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Alpha-galacto-oliosaccharides

Group Type EXPERIMENTAL

Alpha-galacto-oligosaccharides

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Alpha-galacto-oligosaccharides

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Cardiometabolism and Nutrition, France

OTHER

Sponsor Role collaborator

Olygose

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01610--43

Identifier Type: -

Identifier Source: org_study_id