Skip to main content
OpenTrials
Completed

NCT Number: NCT01004120

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

School of Chemistry, Food Biosciences and Pharmacy, The University of Reading

Reading, Berkshire, RG6 6AU, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Bimuno

Dietary Supplement

5.5g daily intake

Other names: Galactooligosaccharide

Maltodextrin

Dietary Supplement

5.5g daily intake

Other names: Dexrins

Primary outcomes

  1. Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.

    Time frame: 3 months

  2. Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)

    Time frame: 3 months

  3. Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)

    Time frame: 3 months

Secondary outcomes

  1. Insulin resistance derived from fasted measures of glucose and insulin ratio

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Clasado

Industry

Collaborators

  • University of Reading

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Oct 29, 2009
Registry last updated
Mar 25, 2016

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.

Published trials that share one or more normalized conditions with this study.