NCT00904124

Brief Summary

It has been suggested that dietary fibers can affect food intake and satiation. Satiation, or meal termination, can be induced by sensory properties and energy density of fiber-rich food products, but also by the chemical/physical/rheological behavior of the fibers in the stomach and/or intestine. It is not clear which properties are the key regulators of satiation by fiber sources. There are many types of dietary fiber, which have diverse sensory and chemical properties, thus these might have different effects on satiation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2009

Typical duration for not_applicable healthy

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

May 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

May 11, 2010

Status Verified

May 1, 2010

Enrollment Period

2 months

First QC Date

May 17, 2009

Last Update Submit

May 10, 2010

Conditions

Keywords

Dietary fiberguar gumalginatecellulosefood intakeeating behaviour

Outcome Measures

Primary Outcomes (1)

  • Ad libitum intake

    1 hour and 2 hours

Secondary Outcomes (1)

  • eating rate

    1 hour and 2 hours

Study Arms (6)

Control

PLACEBO COMPARATOR

No regular flour replaced

Dietary Supplement: cellulose, alginate, guar gum

5% Cellulose

EXPERIMENTAL

5% regular flour is replaced by cellulose

Dietary Supplement: cellulose, alginate, guar gum

2.5% Alginate

EXPERIMENTAL

2.5% regular flour is replaced by Alginate

Dietary Supplement: cellulose, alginate, guar gum

5% Alginate

EXPERIMENTAL

5% regular flour is replaced by Alginate

Dietary Supplement: cellulose, alginate, guar gum

2.5% Guar gum

EXPERIMENTAL

2.5% regular flour is replaced by Guar gum

Dietary Supplement: cellulose, alginate, guar gum

1.25% Guar gum

EXPERIMENTAL

1.25% regular flour is replaced by Guar gum

Dietary Supplement: cellulose, alginate, guar gum

Interventions

6 different food products are developed with different dosages of dietary fiber. Regular flour is replaced by dietary fiber, dosages are described in the 'arms'section.

1.25% Guar gum2.5% Alginate2.5% Guar gum5% Alginate5% CelluloseControl

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-50 years
  • BMI: 18-25 kg/m2
  • Healthy: as judged by the participant

You may not qualify if:

  • Weight loss or weight gain of more than 5 kg during the last 2 months
  • Using an energy restricted diet during the last 2 months
  • Lack of appetite for any (unknown) reason
  • Having problems with chewing and swallowing
  • Having problems with digestion
  • Restrained eater
  • Hypersensitivity for gluten or other ingredients of chocolate cookies
  • Hypersensitivity for one of the fibers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, 6703 HD, Netherlands

Location

Related Publications (1)

  • Wanders AJ, Jonathan MC, van den Borne JJ, Mars M, Schols HA, Feskens EJ, de Graaf C. The effects of bulking, viscous and gel-forming dietary fibres on satiation. Br J Nutr. 2013 Apr 14;109(7):1330-7. doi: 10.1017/S0007114512003145. Epub 2012 Jul 31.

MeSH Terms

Conditions

Feeding Behavior

Interventions

CelluloseAlginatesguar gum

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Edith Feskens, Dr

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2009

First Posted

May 19, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Study Completion

May 1, 2010

Last Updated

May 11, 2010

Record last verified: 2010-05

Locations