Efficacy of a Prebiotic Galactooligosaccharide to Reduce Metabolic Syndrome Risk Factors in Overweight Adults
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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 |
- 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 ]
- 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 |
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| United Kingdom | |
| School of Chemistry, Food Biosciences and Pharmacy, The University of Reading | |
| Reading, Berkshire, United Kingdom, RG6 6AU | |
| 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:
|
Overweight Metabolic Syndrome X Body Weight Signs and Symptoms |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013