NCT01025375

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

1.1 years

First QC Date

December 2, 2009

Last Update Submit

August 29, 2012

Conditions

Obesity

Keywords

overweight

Outcome Measures

Primary Outcomes (1)

  • food intake

    on testday 0 and 13

Secondary Outcomes (2)

  • appetite profile ratings

    on test day 0, 8 and 13 (at 16 time points)

  • satiety hormones (GLP-1 and PYY)

    on test day 0 and 13 (at 9 time points

Interventions

inulinDIETARY_SUPPLEMENT

10gram/day inulin for 13-day treatment

Also known as: oligofructose
placeboDIETARY_SUPPLEMENT

16gram/day maltodextrin (placebo) for 13-day treatment

Also known as: maltodextrin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

ObesityOverweight

Interventions

Inulinoligofructosemaltodextrin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Klaas R Westerterp, Prof

    NUTRIM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 3, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

NL(1)