Trial | NCT01004120  Report issue

Title

Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
Double-blind, Placebo Controlled, Randomised, Cross-over Study to Determine the Effect of a Prebiotic Galactooligosaccharide on Microbiota and Metabolic Syndrome Risk Factors in Overweight Adults

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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.
Study Started
Oct 31
2009
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2012
Last Update
Mar 25
2016
Estimate

Dietary Supplement Bimuno

5.5g daily intake

  • Other names: Galactooligosaccharide

Dietary Supplement Maltodextrin

5.5g daily intake

  • Other names: Dexrins

MDn Placebo Comparator

B-GOS Active Comparator

Criteria 

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
No Results Posted