Effects of Inulin on Satiety and Food Intake (Inulin)

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

Tracking Information

• First Submitted Date: December 2, 2009
• First Posted Date: December 3, 2009
• Last Update Posted Date: August 30, 2012
• Study Start Date: January 2009
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 2, 2009): food intake [ Time Frame: on testday 0 and 13 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Inulin on Satiety and Food Intake
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Obesity

Intervention

• 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: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2009): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT01025375
• Other Study ID Numbers: HumBio_Westerterp08_2
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Maastricht University Medical Center
• Study Sponsor: Maastricht University Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Klaas R Westerterp, Prof; NUTRIM

• PRS Account: Maastricht University Medical Center
• Verification Date: August 2012