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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

Study Description
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Brief Summary:
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: inulin Dietary Supplement: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Effects of Inulin on Satiety and Food Intake
Study Start Date : January 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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

Outcome Measures
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Primary Outcome Measures :
  1. food intake [ Time Frame: on testday 0 and 13 ]

Secondary Outcome Measures :
  1. appetite profile ratings [ Time Frame: on test day 0, 8 and 13 (at 16 time points) ]
  2. satiety hormones (GLP-1 and PYY) [ Time Frame: on test day 0 and 13 (at 9 time points ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01025375


Locations
Netherlands
Maastricht University
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Klaas R Westerterp, Prof NUTRIM
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01025375     History of Changes
Other Study ID Numbers: HumBio_Westerterp08_2
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Maastricht University Medical Center:
overweight