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Effects of Inulin on Satiety and Food Intake (Inulin)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01025375
First received: December 2, 2009
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
  Purpose
To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.

Condition Intervention
Obesity
 Dietary Supplement: inulin
Dietary Supplement: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Effects of Inulin on Satiety and Food Intake

Resource links provided by NLM:

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

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • food intake [ Time Frame: on testday 0 and 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • appetite profile ratings [ Time Frame: on test day 0, 8 and 13 (at 16 time points) ] [ Designated as safety issue: No ]
  • satiety hormones (GLP-1 and PYY) [ Time Frame: on test day 0 and 13 (at 9 time points ] [ Designated as safety issue: No ]
Enrollment: 30
Study Start Date: January 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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
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?
  Eligibility
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01025375     History of Changes
Other Study ID Numbers: HumBio_Westerterp08_2 
Study First Received: December 2, 2009
Last Updated: August 29, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
overweight

ClinicalTrials.gov processed this record on September 26, 2016