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The Effects of Fiber on Appetite and Digestion Hormones (FS)

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ClinicalTrials.gov Identifier: NCT01050101
Recruitment Status : Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Institute for Food Safety and Health, United States

Brief Summary:
In this research study, investigators are interested in how certain dietary fibers in the diet affect certain hormones released from your intestine after eating and how these influence your appetite. The study hypothesis is that certain fibers will slow digestion and absorption of nutrients thereby optimizing fullness,reducing food intake and limiting insulin response in pre- and post-menopausal women.

Condition or disease Intervention/treatment Phase
Psychological Phenomena and Processes Nutrition Physiological Phenomena Dietary Supplement: No fiber Dietary Supplement: Low GI high fiber viscous meal Dietary Supplement: Low GI high fiber non-viscous Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: The Effect of Meal Viscosity on Postprandial Metabolic, Gut Hormone and Satiety Responses to Low and High Glycemic Index Preload Meals in Overweight Pre- and Post-menopausal Women.
Actual Study Start Date : August 1, 2008
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: High GI low fiber meal
No fiber control meal
Dietary Supplement: No fiber

The High GI low fiber meal consists of 0 grams fiber with total kcal of 573 with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein.

Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.

Active Comparator: Low GI high fiber viscous meal
80:20 ratio of viscous polysaccharide fiber to insoluble non-viscous producing fiber
Dietary Supplement: Low GI high fiber viscous meal

Test meal consists of 12 grams of fiber (9 grams soluble and 3 grams insoluble). The ratio is 80:20 ratio of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose).

Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.

Active Comparator: Low GI high fiber non-viscous meal
20:80 ratio of viscous polysaccharide fiber source to insoluble non-viscous producing fiber
Dietary Supplement: Low GI high fiber non-viscous

Test meal consists of 11 grams of fiber (3 grams soluble and 8 grams insoluble). The ratio is 20:80 of viscous polysaccharide fiber source (psyllium husk) to insoluble non-viscous producing fiber source (cellulose).

Total kcal provided as 560 kcal with 63% energy from carbohydrates, 24% energy from fat and 13% energy from protein. Test meal consists of breakfast meals containing muffins and yogurt beverage/shake.




Primary Outcome Measures :
  1. To investigate the effects of viscous polysaccharide fibers on postprandial satiety and meal-associated metabolic response patterns. [ Time Frame: 0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes ]

Secondary Outcome Measures :
  1. To characterize the subjective and behavioral satiety responses to study-specific preload meals varying in viscous fiber content as well as determine the relationship of these satiety responses to the preload-associated physiological responses. [ Time Frame: 0, 20, 40, 60, 90, 120, 150, 180, 210, 240 minutes ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • 18 years or older
  • Unrestrained [score ≤ 10] on the Eating Inventory (EI) questionnaire
  • Pre-menopausal with spontaneous cycle
  • Post-menopausal ≥ 12 month without menstruation
  • Body mass index (BMI) of either 25 to 33 kg/m2, inclusive

Exclusion Criteria:

  • Pregnant and lactating
  • Smoking
  • Allergies or intolerances to foods consumed in the study
  • Fasting glucose > 110 mg/dL
  • Active modification to diet or exercise patterns to gain or lose weight in previous 60 days
  • Unstable body weight (fluctuations of ≥ 5 kg in 60 day period)
  • Excessive exercisers or trained athletes
  • Taking any medications that would affect appetite or have a current or past (previous 1 year) medical condition that may interfere with any of the outcomes of this study.
  • Hormonal therapy (ie., estrogen, progesterone)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050101


Locations
United States, Illinois
Clinical Nutrition Research Center
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
Institute for Food Safety and Health, United States
Investigators
Principal Investigator: Britt Burton-Freeman, MS, PhD Illinois Institute of Technology

Publications:
Responsible Party: Institute for Food Safety and Health, United States
ClinicalTrials.gov Identifier: NCT01050101     History of Changes
Other Study ID Numbers: FS 2009-052
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Institute for Food Safety and Health, United States:
Satiety
Fiber
Nutrition
Pre- and post-menopausal women
overweight

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs