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Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus

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.
 
ClinicalTrials.gov Identifier: NCT01163006
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Tate and Lyle Ingredients France
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE July 14, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date January 9, 2018
Study Start Date  ICMJE March 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
fat oxidation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
24h glucose pattern
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus
Official Title  ICMJE Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Not Provided
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Obesity
Intervention  ICMJE Other: Polydextrose and soluble gluco fibre
Polydextrose and soluble gluco fibre
Study Arms  ICMJE
  • Experimental: polydextrose
    Intervention: Other: Polydextrose and soluble gluco fibre
  • Experimental: soluble glucofibre
    Intervention: Other: Polydextrose and soluble gluco fibre
  • Placebo Comparator: isocaloric dietary control
    Intervention: Other: Polydextrose and soluble gluco fibre
  • Placebo Comparator: full caloric control
    Intervention: Other: Polydextrose and soluble gluco fibre
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Overweight men and women

Exclusion Criteria:

  • regular smokers, athletes, diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163006
Other Study ID Numbers  ICMJE MEC 09-3-084
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Tate and Lyle Ingredients France
Investigators  ICMJE Not Provided
PRS Account Maastricht University Medical Center
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP