Effects of Inulin on Satiety and Food Intake | NCT01025375

Studies
Effects of Inulin on Satiety and Food Intake

NCT01025375

Sponsor

Maastricht University Medical Center

Status

Completed

Last Update Posted

Aug 30, 2012Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

inulin
inulin
placebo

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Feb 2010Actual

Completion Date

Feb 2010Actual

First Submitted Date

Dec 2, 2009

First Submission Date that Met QC Criteria

Dec 2, 2009

First Posted Date

Dec 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2012

Last Update Posted Date

Aug 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Other Names
inulin	Dietary Supplement	10gram/day inulin for 13-day treatment	oligofructose
inulin	Dietary Supplement	16gram/day inulin for 13-day treatment	oligofructose
placebo	Dietary Supplement	16gram/day maltodextrin (placebo) for 13-day treatment	maltodextrin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
food intake		on testday 0 and 13

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Klaas R Westerterp, Prof	NUTRIM	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maastricht University		Maastricht	Limburg	6229ER	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007444	Inulin
C120489	oligofructose
C008315	maltodextrin

Ancestor Terms

ID	Term
D013213	Starch
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911

Browse Leaves

Not provided

Browse Branches

Not provided