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

Phase 1

Completed

• Conditions: Metabolic Syndrome X
• Interventions: Dietary Supplement: Maltodextrin; Dietary Supplement: Bimuno

• Registration Number: NCT01004120
• Lead Sponsor: Clasado

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-28
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
MDn	Maltodextrin	-
B-GOS	Bimuno	-

Primary Outcome Measures

Name	Time	Method
Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.	3 months
Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)	3 months
Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)	3 months

Secondary Outcome Measures

Name	Time	Method
Insulin resistance derived from fasted measures of glucose and insulin ratio	3 months

Trial Locations

Locations (1)

School of Chemistry, Food Biosciences and Pharmacy, The University of Reading; 🇬🇧 Reading, Berkshire, United Kingdom