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

Olygose

Status: Completed

Conditions: Controlled; Double Blind; Randomized Versus Placebo

Treatments: Dietary Supplement: Alpha-galacto-oligosaccharides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02228746

2012-A01610--43

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Alpha-galacto-oliosaccharides

Experimental group

Treatment:

Dietary Supplement: Alpha-galacto-oligosaccharides

Placebo

Placebo Comparator group