NCT03241238

Brief Summary

This study will investigate the effects of different fermenting fibers on liking of foods.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

July 25, 2017

Last Update Submit

July 13, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • Hunger

    100 mm Visual analog scale

    Change across the meal, 20 minutes

  • Fullness

    100 mm Visual analog scale

    Change across the meal, 20 minutes

  • Liking

    100 mm Visual analog scale

    Change across the meal, 20 minutes

Study Arms (3)

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.

Other: Eating

Psyllium Brownie

OTHER

For the psyllium brownie (PG), participants will consume a psyllium brownie and then consume a meal 20 minutes later.

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

Other: Eating

Interventions

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).

Psyllium BrownieRegular Brownieβ-glucan Brownie

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (9)

  • 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.

    PMID: 11110999BACKGROUND
  • 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.

    PMID: 26724486BACKGROUND
  • 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.

    PMID: 27166077BACKGROUND
  • 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.

    PMID: 9093551BACKGROUND
  • 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.

    PMID: 27863994BACKGROUND
  • 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.

    PMID: 9468749BACKGROUND
  • 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.

    PMID: 3981480BACKGROUND
  • Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.

    BACKGROUND
  • Overweight and Obesity Statistics. (2012). Retrieved February 10, 2017, from https://www.niddk.nih.gov/health-information/health-statistics/Pages/overweight-obesity-statistics.aspx

    BACKGROUND

MeSH Terms

Interventions

Eating

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Advisor

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 7, 2017

Study Start

July 24, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations