Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults

Clasado

Status and phase: Completed; Phase 2; Phase 1

Conditions: Metabolic Syndrome X

Treatments: Dietary Supplement: Bimuno; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01004120

COMSE

Details and patient eligibility

About

The traditional risk factors for obesity are inappropriate diet, lack of exercise and genetic factors. However, recent observations have involved gut microbiota profiles as having an additional influence. In this case, there exists the possibility to modulate this through diet. Research has shown that the gut microbiota of both obese humans and mouse models of obesity is altered towards less beneficial one compared to lean counterparts. This raises the possibility of modulating the gut microbiota as a novel strategy in tackling the epidemic of obesity and diabetes sweeping the developed world. In addition, a more direct effect of high-fat induced disruption of the intestinal microbiota has also been seen with a murine model. Elevated circulating levels of lipopolysaccharide (LPS) a major building block and antigen of Gram-negative bacteria, was shown to generate a low grade chronic inflammation, termed metabolic endotoxemia, which then onsets insulin resistance. High-fat diets were shown to disrupt the Gram-negative intestinal populations of these animals, liberating LPS. The effects of prebiotics on the microbiota or metabolic syndrome (combination of disorders that increase the risk of developing cardiovascular disease and diabetes) in overweight adults have not been investigated thus far. The investigators therefore propose to investigate the effect of galactooligosaccharide (GOS) on the faecal microbiota and metabolic syndrome risk factors in overweight adults in a double-blind, randomised, placebo controlled, cross-over trial.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-65y
• BMI >25 kg/m2

Exclusion criteria

• Suffered from a myocardial infarction/stroke or cancer in the past 12 months
• Diabetic or suffering from endocrine disorders
• Suffer from renal or bowel disease/gut disorder or have a history of cholestatic jaundice or pancreatitis
• Requirements to take long-term medication for hyperlipidaemia, hypertension, inflammation or hypercoagulation
• History of alcohol or drug abuse
• Planning or on a weight reducing regime
• Taking antioxidant (or phytochemical), probiotic or prebiotics supplements
• Pregnant or lactating women or those planning pregnancy in the next 6 months or of child-bearing age who are not using contraception
• Use of antibiotics within the previous 1 month
• Anemic
• Smoker

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

MDn

Placebo Comparator group

Treatment:

Dietary Supplement: Maltodextrin

B-GOS

Active Comparator group

Treatment:

Dietary Supplement: Bimuno