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

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 Overview

• Status: Completed
• Conditions: Metabolic Syndrome X
• Intervention / Treatment: Dietary supplement: Maltodextrin; Dietary supplement: Bimuno

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6AU
      • School of Chemistry, Food Biosciences and Pharmacy, The University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: MDn	Dietary supplement: Maltodextrin; 5.5g daily intake; Other Names: Dexrins
Active Comparator: B-GOS	Dietary supplement: Bimuno; 5.5g daily intake; Other Names: Galactooligosaccharide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Insulin resistance derived from fasted measures of glucose and insulin ratio	3 months

Collaborators and Investigators

• Sponsor: Clasado
• Collaborators: University of Reading
• Investigators: Principal Investigator: Jelena Vulevic, PhD, The University of Reading

Publications and helpful links

General Publications

• Vulevic J, Juric A, Tzortzis G, Gibson GR. A mixture of trans-galactooligosaccharides reduces markers of metabolic syndrome and modulates the fecal microbiota and immune function of overweight adults. J Nutr. 2013 Mar;143(3):324-31. doi: 10.3945/jn.112.166132. Epub 2013 Jan 9.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: October 28, 2009
• First Posted (Estimate): October 29, 2009

Study Record Updates

• Last Update Posted (Estimate): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Overweight
• Other Study ID Numbers: COMSE