Effects of Fiber on Satiety

This study is currently recruiting participants.

Verified April 2012 by National Starch LLC

Sponsor:

Information provided by (Responsible Party):

National Starch LLC

ClinicalTrials.gov Identifier:

NCT01588600

First received: April 10, 2012

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Purpose

The effects of a dietary fiber on hunger and food intake will be tested in men and women. Participants will receive fiber as part of a breakfast meal on two occasions. On another occasion, participants will receive the same breakfast, without added fiber. Their feelings of hunger and fullness will be measured over the day. They will be offered lunch, dinner and an evening snack and how much they eat will be recorded. It is expected that the fiber supplement will enhance their feelings of satiety and reduce the amount they eat over the day.

Condition	Intervention
Obesity	Other: Dietary Fiber

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Official Title:	Effects of Fiber on Satiety and Food Intake in Men and Women

Resource links provided by NLM:

MedlinePlus related topics: Dietary Fiber Obesity

U.S. FDA Resources

Further study details as provided by National Starch LLC:

Primary Outcome Measures:

Food intake [ Time Frame: 24-hr food intake, on three occasions within 3 weeks ] [ Designated as safety issue: No ]
24-hour Food intake will be measured 3 times

Secondary Outcome Measures:

Subjective appetite ratings [ Time Frame: Hourly, over 8 hrs, on 3 days within a 3-week period ] [ Designated as safety issue: No ]
Ratings of hunger and fullness will be assessed 18 times

Estimated Enrollment:	90
Study Start Date:	April 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control Breakfast without fiber	Other: Dietary Fiber Fiber added to breakfast
Experimental: Low-dose Low-dose of fiber in breakfast	Other: Dietary Fiber Fiber added to breakfast
Experimental: High-dose high dose of fiber added to breakfast	Other: Dietary Fiber Fiber added to breakfast

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

normal-weight adults

Exclusion Criteria:

eating disorders,
on medications that affect food intake,
pregnant or lactating,
non-breakfast eaters

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588600

Contacts

Contact: Joanne A Harrold, PhD

44 151 794 1129

harrold@liverpool.ac.uk

Locations

United Kingdom
Kissileff Laboratory for the Study of Human Ingestive Behavior	Recruiting
Liverpool, United Kingdom, L69 7ZA
Contact: Joanne Harrold, PhD 44 151 794 1129 harrold@liverpool.ac.uk
Principal Investigator: Jason Halford, PhD

Sponsors and Collaborators

National Starch LLC

Investigators

Principal Investigator:

Jason Halford, PhD

University of Liverpool

More Information

No publications provided

Responsible Party:	National Starch LLC
ClinicalTrials.gov Identifier:	NCT01588600 History of Changes
Other Study ID Numbers:	UL001
Study First Received:	April 10, 2012
Last Updated:	April 27, 2012
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by National Starch LLC:

food intake, satiety, fiber

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013

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