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Effects of Fiber on Satiety

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by National Starch LLC.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 25, 2014