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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01004120
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : March 25, 2016
Sponsor:
Collaborator:
University of Reading
Information provided by (Responsible Party):
Clasado

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis. [ Time Frame: 3 months ]
  • Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids) [ Time Frame: 3 months ]
  • Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA) [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Insulin resistance derived from fasted measures of glucose and insulin ratio [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome X
Intervention  ICMJE
  • Dietary Supplement: Bimuno
    5.5g daily intake
    Other Name: Galactooligosaccharide
  • Dietary Supplement: Maltodextrin
    5.5g daily intake
    Other Name: Dexrins
Study Arms  ICMJE
  • Placebo Comparator: MDn
    Intervention: Dietary Supplement: Maltodextrin
  • Active Comparator: B-GOS
    Intervention: Dietary Supplement: Bimuno
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2016)
48
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)
50
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004120
Other Study ID Numbers  ICMJE COMSE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clasado
Study Sponsor  ICMJE Clasado
Collaborators  ICMJE University of Reading
Investigators  ICMJE
Principal Investigator: Jelena Vulevic, PhD The University of Reading
PRS Account Clasado
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP