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Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tate and Lyle Ingredients France
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01163006
First received: July 14, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • fat oxidation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 24h glucose pattern [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Overweight men and women

Exclusion Criteria:

  • regular smokers, athletes, diabetes mellitus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Ellen E Blaak, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01163006     History of Changes
Other Study ID Numbers: MEC 09-3-084
Study First Received: July 14, 2010
Last Updated: July 14, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013