Effects of Inulin on Satiety and Food Intake

Obesity Clinical Trial

— Inulin  

Official title:

Effects of Inulin on Satiety and Food Intake

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025375
• Other study ID #: HumBio_Westerterp08_2
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: August 29, 2012
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: August 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

To assess the effect of inulin on appetite profile ratings, food intake and satiety hormones.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• inulin
10gram/day inulin for 13-day treatment
• inulin
16gram/day inulin for 13-day treatment
• placebo
16gram/day maltodextrin (placebo) for 13-day treatment

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	food intake		on testday 0 and 13	No
Secondary	appetite profile ratings		on test day 0, 8 and 13 (at 16 time points)	No
Secondary	satiety hormones (GLP-1 and PYY)		on test day 0 and 13 (at 9 time points	No