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Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163006
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tate and Lyle Ingredients France
Information provided by:
Maastricht University Medical Center
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Obesity Other: Polydextrose and soluble gluco fibre

Study Type: Interventional
Official Title: Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • fat oxidation

Secondary Outcome Measures:
  • 24h glucose pattern

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: polydextrose Other: Polydextrose and soluble gluco fibre
Polydextrose and soluble gluco fibre
Experimental: soluble glucofibre Other: Polydextrose and soluble gluco fibre
Polydextrose and soluble gluco fibre
Placebo Comparator: isocaloric dietary control Other: Polydextrose and soluble gluco fibre
Polydextrose and soluble gluco fibre
Placebo Comparator: full caloric control Other: Polydextrose and soluble gluco fibre
Polydextrose and soluble gluco fibre

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight men and women

Exclusion Criteria:

  • regular smokers, athletes, diabetes mellitus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163006


Contacts
Contact: Ellen E Blaak, prof +31433881503 E.blaak@hb.unimaas.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Netherlands, 6200 MD
Principal Investigator: Ellen Blaak, prof         
Sponsors and Collaborators
Maastricht University Medical Center
Tate and Lyle Ingredients France
  More Information

Responsible Party: Ellen E Blaak, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01163006     History of Changes
Other Study ID Numbers: MEC 09-3-084
First Submitted: July 14, 2010
First Posted: July 15, 2010
Last Update Posted: July 15, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases