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

This study has been completed.
Sponsor:
Collaborator:
University of Reading
Information provided by:
Clasado
ClinicalTrials.gov Identifier:
NCT01004120
First received: October 28, 2009
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Metabolic Syndrome X
Dietary Supplement: Bimuno
Dietary Supplement: Maltodextrin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Clasado:

Primary Outcome Measures:
  • Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance derived from fasted measures of glucose and insulin ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: MDn Dietary Supplement: Maltodextrin
5.5g daily intake
Other Name: Dexrins
Active Comparator: B-GOS Dietary Supplement: Bimuno
5.5g daily intake
Other Name: Galactooligosaccharide

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004120

Locations
United Kingdom
School of Chemistry, Food Biosciences and Pharmacy, The University of Reading
Reading, Berkshire, United Kingdom, RG6 6AU
Sponsors and Collaborators
Clasado
University of Reading
Investigators
Principal Investigator: Jelena Vulevic, PhD The University of Reading
  More Information

No publications provided by Clasado

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Tzortzis, Clasado
ClinicalTrials.gov Identifier: NCT01004120     History of Changes
Other Study ID Numbers: COMSE
Study First Received: October 28, 2009
Last Updated: February 18, 2011
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Metabolic Syndrome X
Overweight
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014