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

Metabolic Syndrome X Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01004120
• Other study ID #: COMSE
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 28, 2009
• Last updated: March 24, 2016
• Start date: October 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2016
• Source: Clasado
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Bimuno
5.5g daily intake
• Maltodextrin
5.5g daily intake

Locations

Country	Name	City	State
United Kingdom	School of Chemistry, Food Biosciences and Pharmacy, The University of Reading	Reading	Berkshire

Sponsors (2)

Lead Sponsor	Collaborator
Clasado	University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.		3 months	No
Primary	Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)		3 months	No
Primary	Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)		3 months	No
Secondary	Insulin resistance derived from fasted measures of glucose and insulin ratio		3 months	No