NCT01004120

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

2.2 years

First QC Date

October 28, 2009

Last Update Submit

March 24, 2016

Conditions

Metabolic Syndrome X

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Insulin resistance derived from fasted measures of glucose and insulin ratio

    3 months

Study Arms (2)

MDn

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin

B-GOS

ACTIVE COMPARATOR
Dietary Supplement: Bimuno

Interventions

BimunoDIETARY_SUPPLEMENT

5.5g daily intake

Also known as: Galactooligosaccharide
B-GOS
MaltodextrinDIETARY_SUPPLEMENT

5.5g daily intake

Also known as: Dexrins
MDn

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>25 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Chemistry, Food Biosciences and Pharmacy, The University of Reading

Reading, Berkshire, RG6 6AU, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23303873DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

4'-galactooligosaccharidemaltodextrin

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jelena Vulevic, PhD

    The University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

GB(1)