Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Bimuno
Maltodextrin
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
Eligibility 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
Sites / Locations
- School of Chemistry, Food Biosciences and Pharmacy, The University of Reading
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
MDn
B-GOS
Arm Description
Outcomes
Primary Outcome Measures
Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.
Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)
Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)
Secondary Outcome Measures
Insulin resistance derived from fasted measures of glucose and insulin ratio
Full Information
NCT ID
NCT01004120
First Posted
October 28, 2009
Last Updated
March 24, 2016
Sponsor
Clasado
Collaborators
University of Reading
1. Study Identification
Unique Protocol Identification Number
NCT01004120
Brief Title
Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clasado
Collaborators
University of Reading
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDn
Arm Type
Placebo Comparator
Arm Title
B-GOS
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Bimuno
Other Intervention Name(s)
Galactooligosaccharide
Intervention Description
5.5g daily intake
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Other Intervention Name(s)
Dexrins
Intervention Description
5.5g daily intake
Primary Outcome Measure Information:
Title
Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis.
Time Frame
3 months
Title
Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids)
Time Frame
3 months
Title
Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Insulin resistance derived from fasted measures of glucose and insulin ratio
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jelena Vulevic, PhD
Organizational Affiliation
The University of Reading
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Chemistry, Food Biosciences and Pharmacy, The University of Reading
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG6 6AU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23303873
Citation
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.
Results Reference
derived
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Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
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