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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00904124
Other study ID # 0902-face
Secondary ID
Status Completed
Phase N/A
First received May 17, 2009
Last updated May 10, 2010
Start date May 2009
Est. completion date May 2010

Study information

Verified date May 2010
Source Wageningen University
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

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.


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date May 2010
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Age: 18-50 years

- BMI: 18-25 kg/m2

- Healthy: as judged by the participant

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
cellulose, alginate, guar gum
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.

Locations

Country Name City State
Netherlands Wageningen University Wageningen

Sponsors (1)

Lead Sponsor Collaborator
Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ad libitum intake 1 hour and 2 hours No
Secondary eating rate 1 hour and 2 hours No
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