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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolic Syndrome X

Intervention / Treatment
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* Dietary Supplement: Bimuno
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: MDn<br> | Dietary Supplement: Maltodextrin<br>* 5.5g daily intake<br>* Other names: Dexrins;|
| Active Comparator: B-GOS<br> | Dietary Supplement: Bimuno<br>* 5.5g daily intake<br>* Other names: Galactooligosaccharide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Faecal microbiota changes enumerated by Fluorescent In Situ Hybridisation and qualitatively assessed by Denaturing Gradient Gel Electrophoresis. |  | 3 months | 
| Lipid profile (total, LDL and HDL cholesterol, triglycerides and non-esterified fatty acids) |  | 3 months | 
| Inflammatory/thrombotic biomarkers (including C-reactive protein, TNF-a, IL6, IL-8, IL-10, sCD40L, sP-selectin, t-PA) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin resistance derived from fasted measures of glucose and insulin ratio |  | 3 months |