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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01004120
Enrollment
48
Registered
2009-10-29
Start date
2009-10-31
Completion date
2012-12-31
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome X

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.

Interventions

DIETARY_SUPPLEMENTBimuno

5.5g daily intake

DIETARY_SUPPLEMENTMaltodextrin

5.5g daily intake

Sponsors

University of Reading
CollaboratorOTHER
Clasado
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Insulin resistance derived from fasted measures of glucose and insulin ratio3 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026