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Withdrawn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
About this trial
This is an interventional treatment trial for Appetitive Behavior
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
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
NCT ID
NCT04737629
First Posted
January 21, 2021
Last Updated
August 24, 2023
Sponsor
University of Florida
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
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Results Reference
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PubMed Identifier
8287852
Citation
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PubMed Identifier
18589036
Citation
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PubMed Identifier
20796216
Citation
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students
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