- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03241238
The Effect of Dietary Fiber on Food Liking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants will be randomized to one of three orders to reduce the possibility of an order effect.The participants will be given a brownie specific for the condition they are in and then will be instructed to eat the brownie in 10 minutes. Twenty minutes after consuming the brownie participants will be served a lunch. Dependent variables will be food liking.
At the start of the session the participant will be asked to recall all foods and beverages consumed 24 hours prior to the scheduled appointment. During this recall if a participant reports consuming any foods or beverages besides water within 3 hours of the appointment, the appointment will be rescheduled. Participants will also be asked if they have participated in any physical activity 24 hours prior to their scheduled appointment. If the participant answers "yes," then the appointment will be rescheduled.
After completing hunger and fullness VAS, participants will be presented with a preload of brownie, β-glucan brownie, or psyllium brownie. The brownie will be prepared from the same base recipe, thus be of the same approximate energy and macronutrient composition, but differ in amount and type of dietary fiber. The base recipe will use a box of Pillsbury™ dark chocolate brownie mix, two eggs, ¼ cup water and 2/3 cup of Food Club™ unsweetened applesauce. The regular brownie will not contain any fiber, while the β-glucan and psyllium brownie will contain about 6 grams of their respective fiber: Bulk Supplements™ β-glucan and Frontier™ Psyllium Husk Powder. An additional tablespoon of water will be added to the β-glucan brownie mix. The brownie will be presented warm, with two tablespoons of Cool Whip™ fat free spread on top, with 6 ounces of water. The participants will be told to consume all of the brownie and toping, and to drink all of the 6 oz of water within 10 minutes. Next, participants will rate their hunger and fullness again with the VAS and sit quietly for 20 minutes reading current magazines (i.e., People, Entertainment Weekly). After 20 minutes, the participants will be presented with a sandwich (turkey or ham), chips, and grapes.The sandwich will be cut into quarters on a plate, the chips and grapes will be presented in two separate bowls. Following the presentation of the meal, participants will be instructed that they will have 20 minutes to eat as much or as little as they would like of the meal provided until satisfied, however they need to at least taste each of the foods. At the completion of 20 minutes, the lunch will be removed and the participant will be asked to complete a scale for evaluating levels of hunger, fullness, and liking of the foods.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Knoxville, Tennessee, United States, 37996
- Healthy Eating and Activity Laboratory, University of Tennessee
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Body mass index (BMI) between 18.5 to 24.9 kg/m^2
- Unrestrained eater (<12 on Three Factor Eating Questionnaire [TFEQ])
- report liking turkey or ham sandwiches, brownies, grapes, and potato chips (rate all items >50mm on a visual analogue scale [VAS]).
- Report regularly eating before 10 am
- Can completed all sessions within 6 weeks of the screening session.
Exclusion Criteria:
- Report binge eating
- Report a medical condition that influences eating
- Report food allergies to the study foods
- Currently smoke
- Report dietary restrictions
- Report not liking brownies
- Report currently taking a medication that effects appetite
- Report being pregnant or breast-feeding
- Report being an athlete in training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Regular Brownie
Regular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later.
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Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water.
They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
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Other: Psyllium Brownie
For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later.
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Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water.
They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
|
Other: β-glucan Brownie
For the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later
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Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water.
They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hunger
Time Frame: Change across the meal, 20 minutes
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100 mm Visual analog scale
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Change across the meal, 20 minutes
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Fullness
Time Frame: Change across the meal, 20 minutes
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100 mm Visual analog scale
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Change across the meal, 20 minutes
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Liking
Time Frame: Change across the meal, 20 minutes
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100 mm Visual analog scale
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Change across the meal, 20 minutes
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Collaborators and Investigators
Publications and helpful links
General Publications
- Stunkard AJ, Messick S. The three-factor eating questionnaire to measure dietary restraint, disinhibition and hunger. J Psychosom Res. 1985;29(1):71-83. doi: 10.1016/0022-3999(85)90010-8.
- Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
- Raynor HA, Epstein LH. Effects of sensory stimulation and post-ingestive consequences on satiation. Physiol Behav. 2000 Sep 15;70(5):465-70. doi: 10.1016/s0031-9384(00)00291-2.
- Rebello CJ, O'Neil CE, Greenway FL. Dietary fiber and satiety: the effects of oats on satiety. Nutr Rev. 2016 Feb;74(2):131-47. doi: 10.1093/nutrit/nuv063. Epub 2016 Jan 2.
- Brum JM, Gibb RD, Peters JC, Mattes RD. Satiety effects of psyllium in healthy volunteers. Appetite. 2016 Oct 1;105:27-36. doi: 10.1016/j.appet.2016.04.041. Epub 2016 May 7.
- Delargy HJ, O'Sullivan KR, Fletcher RJ, Blundell JE. Effects of amount and type of dietary fibre (soluble and insoluble) on short-term control of appetite. Int J Food Sci Nutr. 1997 Jan;48(1):67-77. doi: 10.3109/09637489709006965.
- McRorie JW Jr, McKeown NM. Understanding the Physics of Functional Fibers in the Gastrointestinal Tract: An Evidence-Based Approach to Resolving Enduring Misconceptions about Insoluble and Soluble Fiber. J Acad Nutr Diet. 2017 Feb;117(2):251-264. doi: 10.1016/j.jand.2016.09.021. Epub 2016 Nov 15.
- Ridgway PS, Jeffrey DB. A comparison of the Three-Factor Eating Questionnaire and the Restraint Scale and consideration of Lowe's Three-Factor Model. Addict Behav. 1998 Jan-Feb;23(1):115-8. doi: 10.1016/s0306-4603(97)00031-2.
- Overweight and Obesity Statistics. (2012). Retrieved February 10, 2017, from https://www.niddk.nih.gov/health-information/health-statistics/Pages/overweight-obesity-statistics.aspx
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UTK IRB-17-03817-XP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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