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Effects of Inulin on Satiety and Food Intake (Inulin)

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ClinicalTrials.gov Identifier: NCT01025375
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : August 30, 2012
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date August 30, 2012
Study Start Date  ICMJE January 2009
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
food intake [ Time Frame: on testday 0 and 13 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
  • appetite profile ratings [ Time Frame: on test day 0, 8 and 13 (at 16 time points) ]
  • satiety hormones (GLP-1 and PYY) [ Time Frame: on test day 0 and 13 (at 9 time points ]
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 Effects of Inulin on Satiety and Food Intake
Official Title  ICMJE Effects of Inulin on Satiety and Food Intake
Brief Summary To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.
Detailed Description Based upon a slower digestion and the fermentation in the intestinal tract, food containing soluble dietary fibres, such as inulin, is hypothesized to be more satiating, and to limit energy intake, in humans. Does supplementation of inulin (at 2 dosages) versus placebo over 13 consecutive days in normal to overweight men and women, lead to an increase in satiety, a reduction in food intake and stronger postprandial increases in GLP-1 and PYY?
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Obesity
Intervention  ICMJE
  • Dietary Supplement: inulin
    10gram/day inulin for 13-day treatment
    Other Name: oligofructose
  • Dietary Supplement: inulin
    16gram/day inulin for 13-day treatment
    Other Name: oligofructose
  • Dietary Supplement: placebo
    16gram/day maltodextrin (placebo) for 13-day treatment
    Other Name: maltodextrin
Study Arms  ICMJE Not Provided
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
Actual Enrollment  ICMJE
 (submitted: December 2, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age between 18 and 60 years
  • BMI between 23 and 28 kg/m2
  • dietary unrestraint (TFEQ: F1<9)

Exclusion Criteria:

  • age under 18 and above 60 years
  • BMI under 23 and above 28 kg/m2
  • dietary restraint (TFEQ: F1>9)
  • use of medication
  • pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (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 NCT01025375
Other Study ID Numbers  ICMJE HumBio_Westerterp08_2
Has Data Monitoring Committee Yes
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 Not Provided
Investigators  ICMJE
Principal Investigator: Klaas R Westerterp, Prof NUTRIM
PRS Account Maastricht University Medical Center
Verification Date August 2012

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