- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163006
Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus
January 5, 2018 updated by: Maastricht University Medical Center
Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus
Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response.
This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Maastricht, Netherlands, 6200 MD
- Maastricht University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Overweight men and women
Exclusion Criteria:
- regular smokers, athletes, diabetes mellitus
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: polydextrose
|
Polydextrose and soluble gluco fibre
|
Experimental: soluble glucofibre
|
Polydextrose and soluble gluco fibre
|
Placebo Comparator: isocaloric dietary control
|
Polydextrose and soluble gluco fibre
|
Placebo Comparator: full caloric control
|
Polydextrose and soluble gluco fibre
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
fat oxidation
|
Secondary Outcome Measures
Outcome Measure |
---|
24h glucose pattern
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
July 14, 2010
First Posted (Estimate)
July 15, 2010
Study Record Updates
Last Update Posted (Actual)
January 9, 2018
Last Update Submitted That Met QC Criteria
January 5, 2018
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC 09-3-084
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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