Different Fermentable FiberNCT03241238
The Effect of Dietary Fiber on Food Liking
A study testing Eating in people with Different Fermentable Fiber and Satiation, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This study will investigate the effects of different fermenting fibers on liking of foods. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Different Fermentable Fiber, Satiation
- What is being tested?
- Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Report currently taking a medication that effects appetite
- Report being pregnant or breast-feeding
- Report being an athlete in training.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, 37996
About this study
This study will investigate the effects of different fermenting fibers on liking of foods.
Read the 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.
- Conditions
- Different Fermentable Fiber, Satiation
- Being tested
- Eating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EatingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Regular Brownie | Other | Regular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later. Receives: Other: Eating |
| Psyllium Brownie | Other | For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later. Receives: Other: Eating |
| β-glucan Brownie | Other | For the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later Receives: Other: Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hunger
100 mm Visual analog scale
Measured: Change across the meal, 20 minutes
Fullness
100 mm Visual analog scale
Measured: Change across the meal, 20 minutes
Liking
100 mm Visual analog scale
Measured: Change across the meal, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start24 Jul 2017
- Primary completion30 May 2018
- Study completion30 May 2018
Why it stopped: No effect was found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Different Fermentable FiberStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hollie Raynor, The University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241238
- Sponsor's protocol ID
- UTK IRB-17-03817-XP
- Status last verified
- Jul 2019
- First submitted
- 25 Jul 2017
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11110999Rebello 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.
PubMed 26724486Brum 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.
PubMed 27166077Delargy 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.
PubMed 9093551McRorie 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.
PubMed 27863994Ridgway 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.
PubMed 9468749Stunkard 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.
PubMed 3981480Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
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 at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dietary Fiber on Food Liking
- ClinicalTrials.gov ID
- NCT03241238
- Acronym / sponsor ID
- UTK IRB-17-03817-XP
- Conditions
- Different Fermentable Fiber, Satiation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No effect was found
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effects of different fermenting fibers on liking of foods.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular Brownie | Other | Other: EatingRegular Brownie For the regular brownie condition (RB), participants will consume the brownie preload and then consume a meal 20 minutes later. |
| Psyllium Brownie | Other | Other: EatingFor the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later. |
| β-glucan Brownie | Other | Other: EatingFor the β-glucan Brownie (BG), participants will consume a β-glucan Brownie preload and then consume a meal 20 minutes later |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Report binge eating
- Report a medical condition that influences eating
- Report food allergies to the study foods
- Currently smoke
- Report dietary restrictions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EatingParticipants 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 | Psyllium Brownie, Regular Brownie, β-glucan Brownie |
Primary outcome
Hunger
Time frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Fullness
Time frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Liking
Time frame: Change across the meal, 20 minutes
100 mm Visual analog scale
Results and safety
The study was stopped early (reason given: No effect was found). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 11110999Raynor 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.
- Background: PubMed 26724486Rebello 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.
- Background: PubMed 27166077Brum 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.
- Background: PubMed 9093551Delargy 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.
- Background: PubMed 27863994McRorie 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.
- Background: PubMed 9468749Ridgway 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.
- Background: PubMed 3981480Stunkard 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.
- BackgroundLohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
- BackgroundOverweight and Obesity Statistics. (2012). Retrieved February 10, 2017, from https://www.niddk.nih.gov/health-information/health-statistics/Pages/overweight-obesity-statistics.aspx
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eating in people with Different Fermentable Fiber and Satiation, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No effect was found). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hunger (time frame: Change across the meal, 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03241238, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.