Efficacy of a Prebiotic Galactooligosaccharide to Reduce... | NCT01004120

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

NCT01004120

Sponsor

Clasado

Status

Completed

Last Update Posted

Mar 25, 2016Estimated

Enrollment

48Actual

Phase

Phase 1Phase 2

Conditions

Metabolic Syndrome X

Interventions

Bimuno
Maltodextrin

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 28, 2009

First Submission Date that Met QC Criteria

Oct 28, 2009

First Posted Date

Oct 29, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Name	Class
University of Reading	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDn	Placebo Comparator		Dietary Supplement: Maltodextrin
B-GOS	Active Comparator		Dietary Supplement: Bimuno

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bimuno	Dietary Supplement	5.5g daily intake	B-GOS	Galactooligosaccharide

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jelena Vulevic, PhD	The University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
School of Chemistry, Food Biosciences and Pharmacy, The University of Reading		Reading	Berkshire	RG6 6AU	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23303873	Derived	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.

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

ID	Term
C072242	4'-galactooligosaccharide
C008315	maltodextrin