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

Sponsor
Clasado (Industry)
Overall Status
Completed
CT.gov ID
NCT01004120
Collaborator
University of Reading (Other)
48
Enrollment
1
Location
2
Arms
38
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Bimuno
  • Dietary Supplement: Maltodextrin
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, 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
Study Start Date :
Oct 1, 2009
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis. [3 months]

    2. Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids) [3 months]

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

    Secondary Outcome Measures

    1. Insulin resistance derived from fasted measures of glucose and insulin ratio [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clasado
    ClinicalTrials.gov Identifier:
    NCT01004120
    Other Study ID Numbers:
    • COMSE
    First Posted:
    Oct 29, 2009
    Last Update Posted:
    Mar 25, 2016
    Last Verified:
    Mar 1, 2016
    Additional relevant MeSH terms:
    Metabolic Syndrome
    Syndrome
    Overweight

    Study Results

    No Results Posted as of Mar 25, 2016