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Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students

Primary Purpose

Appetitive Behavior, Weight Loss, Water

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Expectancy and Water
No Expectancy and Water
No Water
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appetitive Behavior

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 - 65 years of age
  • rating at least two foods from each category (chips/crackers and sweets/candies) on the food options list for the taste test as a 7 ("like moderately") or higher on a 9-point hedonic scale
  • willing/able to come to the lab for three sessions

Exclusion Criteria:

  • current smoker
  • self-report of a current or past eating disorder diagnosis
  • taking an appetite suppressant or stimulant medication
  • currently engaged in a weight loss program
  • currently pregnant, breastfeeding, or planning to become pregnant
  • allergy to mint

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Expectancy and Water Condition

    No Expectancy and Water Condition

    No Water Condition

    Arm Description

    Outcomes

    Primary Outcome Measures

    Caloric intake
    Weighing food on digital food scale after taste test.

    Secondary Outcome Measures

    Appetite
    Four-question 100mm visual analog scale (VAS) assessing assesses hunger, fullness, satiety, and prospective food consumption. The minimum possible score is 0, and the maximum possible score is 100.
    Physical activity
    International Physical Activity Questionnaire (IPAQ-SF). Participants are categorized into low, moderate, or high levels of physical activity. Higher score indicates more physical activity engagement (better outcome).
    Restrained eating
    Eating Disorder Examination Questionnaire (EDE-Q). The minimum possible score is 0 and maximum possible score is 34.5. A higher score indicates higher restrained eating symptoms (poorer outcome).
    Habitual water intake
    As part of the baseline questionnaire, participants will be asked about how many glasses of water they drank over the past 7 days in order to assess habitual water intake. Response options range from "I did not drink water during the past 7 days" to "4 or more glasses per day."

    Full Information

    First Posted
    January 21, 2021
    Last Updated
    August 24, 2023
    Sponsor
    University of Florida
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04737629
    Brief Title
    Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students
    Official Title
    Understanding the Effects of Herbs on Attention, Coordination, and Taste
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study was never started.
    Study Start Date
    August 2021 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Florida

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Consuming large volumes of water has recently been identified as a common weight loss strategy among U.S. adults. It is a widespread belief that drinking water increases feelings of satiety and reduces food intake, which could contribute to long-term weight maintenance. Many studies have shown support for this, demonstrating water's ability to reduce hunger and energy intake. In some cases, increased water consumption was associated with weight loss. However, the mechanisms of how water affects food intake have been minimally explored. There is potential that the effect of water on reduced food intake and increased satiety is due to individuals' belief that water will reduce their appetite and food intake. The question remains if water expectancy has a meaningful influence on water's ability to reduce food intake. The investigators hypothesize that participants will report less hunger and consume fewer calories when given water and an expectancy that water will affect appetite, compared to a condition when given water and do not expect water to have an effect on appetite. We further hypothesize that calorie intake will not meaningfully differ when participants are given water with no expectancies compared to when given no water. During this experiment, the investigators will vary the presence of water and manipulate expectancies about water's effects on appetite across three conditions: (1) an expectancy and water condition; (2) an expectancy and no water condition; and (3) a no expectancy and water condition. In each condition, participants will engage in a bogus taste test and complete two short cognitive tasks for distraction purposes. In an effort to prevent demand characteristics, this study involves deception. Participants will be told that the research team is interested in testing the effects of three different mint herb variations on attention, coordination, and taste perceptions. After completing the cognitive tasks and taste test, participants will have a 10 minute period to eat as much of the remaining food as they'd like. Food will be weighed before and after this period (without the participant's knowledge) in order to determine caloric intake.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Appetitive Behavior, Weight Loss, Water, Energy Intake

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Expectancy and Water Condition
    Arm Type
    Experimental
    Arm Title
    No Expectancy and Water Condition
    Arm Type
    Experimental
    Arm Title
    No Water Condition
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Expectancy and Water
    Intervention Description
    In the expectancy and water condition, participants will be instructed to consume the mint herb and 500mL of water before the start of the taste test. The script for this condition will inform them of research that has shown water to decrease appetite by up to 50% (attempting to create an expectancy).
    Intervention Type
    Behavioral
    Intervention Name(s)
    No Expectancy and Water
    Intervention Description
    Participants will be instructed to consume the mint herb and 500mL of water before the start of the taste test. The script will inform them of research that has shown water to decrease appetite by up to 50%. In this condition, however, the research team will also inform them that this herb is expected to counteract the effects of water on appetite because it decreases water retention, causing water to pass through the stomach and intestines at a faster than normal rate (attempting to create no water expectancy or nullify any pre-existing expectancy).
    Intervention Type
    Behavioral
    Intervention Name(s)
    No Water
    Intervention Description
    Participants will be instructed to consume the mint herb and 50mL of water before the start of the taste test. Participants will be given 100mL of water during the taste test to aid in their ability to taste and consume food, and to avoid acute thirst interfering with food consumption. Access to fluids during a taste test has been used in control conditions in similar studies. The script for this condition will inform participants of research that has shown water to decrease appetite by up to 50% but acknowledge that they will not be receiving water (thus, they should not expect an effect on appetite).
    Primary Outcome Measure Information:
    Title
    Caloric intake
    Description
    Weighing food on digital food scale after taste test.
    Time Frame
    Through study completion, up to 9 weeks.
    Secondary Outcome Measure Information:
    Title
    Appetite
    Description
    Four-question 100mm visual analog scale (VAS) assessing assesses hunger, fullness, satiety, and prospective food consumption. The minimum possible score is 0, and the maximum possible score is 100.
    Time Frame
    Through study completion, up to 9 weeks.
    Title
    Physical activity
    Description
    International Physical Activity Questionnaire (IPAQ-SF). Participants are categorized into low, moderate, or high levels of physical activity. Higher score indicates more physical activity engagement (better outcome).
    Time Frame
    Assessed at baseline before any experiment administration.
    Title
    Restrained eating
    Description
    Eating Disorder Examination Questionnaire (EDE-Q). The minimum possible score is 0 and maximum possible score is 34.5. A higher score indicates higher restrained eating symptoms (poorer outcome).
    Time Frame
    Assessed at baseline before any experiment administration.
    Title
    Habitual water intake
    Description
    As part of the baseline questionnaire, participants will be asked about how many glasses of water they drank over the past 7 days in order to assess habitual water intake. Response options range from "I did not drink water during the past 7 days" to "4 or more glasses per day."
    Time Frame
    Assessed at baseline before any experiment administration.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 - 65 years of age rating at least two foods from each category (chips/crackers and sweets/candies) on the food options list for the taste test as a 7 ("like moderately") or higher on a 9-point hedonic scale willing/able to come to the lab for three sessions Exclusion Criteria: current smoker self-report of a current or past eating disorder diagnosis taking an appetite suppressant or stimulant medication currently engaged in a weight loss program currently pregnant, breastfeeding, or planning to become pregnant allergy to mint

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD will be shared on the Open Science Framework (OSF) platform following the completion of the study. The study protocol, statistical analysis plan, and de-identified analytic code will be available.
    IPD Sharing Time Frame
    Data will be available within 12 months following the completion of the study.
    IPD Sharing Access Criteria
    No access criteria. De-identified data will be available to anyone.
    Citations:
    PubMed Identifier
    31722029
    Citation
    Han L, You D, Zeng F, Feng X, Astell-Burt T, Duan S, Qi L. Trends in Self-perceived Weight Status, Weight Loss Attempts, and Weight Loss Strategies Among Adults in the United States, 1999-2016. JAMA Netw Open. 2019 Nov 1;2(11):e1915219. doi: 10.1001/jamanetworkopen.2019.15219. Erratum In: JAMA Netw Open. 2019 Dec 2;2(12):e1919047.
    Results Reference
    background
    PubMed Identifier
    8287852
    Citation
    Lappalainen R, Mennen L, van Weert L, Mykkanen H. Drinking water with a meal: a simple method of coping with feelings of hunger, satiety and desire to eat. Eur J Clin Nutr. 1993 Nov;47(11):815-9.
    Results Reference
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    PubMed Identifier
    18589036
    Citation
    Davy BM, Dennis EA, Dengo AL, Wilson KL, Davy KP. Water consumption reduces energy intake at a breakfast meal in obese older adults. J Am Diet Assoc. 2008 Jul;108(7):1236-9. doi: 10.1016/j.jada.2008.04.013.
    Results Reference
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    PubMed Identifier
    20796216
    Citation
    Daniels MC, Popkin BM. Impact of water intake on energy intake and weight status: a systematic review. Nutr Rev. 2010 Sep;68(9):505-21. doi: 10.1111/j.1753-4887.2010.00311.x.
    Results Reference
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    PubMed Identifier
    19661958
    Citation
    Dennis EA, Dengo AL, Comber DL, Flack KD, Savla J, Davy KP, Davy BM. Water consumption increases weight loss during a hypocaloric diet intervention in middle-aged and older adults. Obesity (Silver Spring). 2010 Feb;18(2):300-7. doi: 10.1038/oby.2009.235. Epub 2009 Aug 6.
    Results Reference
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    PubMed Identifier
    25893719
    Citation
    Corney RA, Sunderland C, James LJ. Immediate pre-meal water ingestion decreases voluntary food intake in lean young males. Eur J Nutr. 2016 Mar;55(2):815-819. doi: 10.1007/s00394-015-0903-4. Epub 2015 Apr 18.
    Results Reference
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    PubMed Identifier
    26729162
    Citation
    Stookey JJ. Negative, Null and Beneficial Effects of Drinking Water on Energy Intake, Energy Expenditure, Fat Oxidation and Weight Change in Randomized Trials: A Qualitative Review. Nutrients. 2016 Jan 2;8(1):19. doi: 10.3390/nu8010019.
    Results Reference
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    PubMed Identifier
    26537940
    Citation
    Madjd A, Taylor MA, Delavari A, Malekzadeh R, Macdonald IA, Farshchi HR. Effects on weight loss in adults of replacing diet beverages with water during a hypoenergetic diet: a randomized, 24-wk clinical trial. Am J Clin Nutr. 2015 Dec;102(6):1305-12. doi: 10.3945/ajcn.115.109397. Epub 2015 Nov 4.
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    Citation
    Casazza K, Brown A, Astrup A, Bertz F, Baum C, Brown MB, Dawson J, Durant N, Dutton G, Fields DA, Fontaine KR, Heymsfield S, Levitsky D, Mehta T, Menachemi N, Newby PK, Pate R, Raynor H, Rolls BJ, Sen B, Smith DL Jr, Thomas D, Wansink B, Allison DB. Weighing the Evidence of Common Beliefs in Obesity Research. Crit Rev Food Sci Nutr. 2015;55(14):2014-53. doi: 10.1080/10408398.2014.922044.
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    Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students

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