Appetitive BehaviorNCT04737629
Understanding the Effects of Water-related Appetite Expectancies on Caloric Intake in College Students
A study testing Expectancy and Water, No Expectancy and Water and No Water in people with Appetitive Behavior and Weight Loss, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Appetitive Behavior, Weight Loss, Water
- What is being tested?
- Expectancy and Water, No Expectancy and Water and No Water
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2021to Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Understanding the Effects of Herbs on Attention, Coordination, and Taste
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.
- Conditions
- Appetitive Behavior, Weight Loss, Water, Energy Intake
- Being tested
- Expectancy and Water, No Expectancy and Water, No Water
- Medical subject headings
- Appetitive Behavior, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expectancy and WaterBehavioural
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).
No Expectancy and WaterBehavioural
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).
No WaterBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Expectancy and Water Condition | Experimental | Not described Receives: Behavioral: Expectancy and Water |
| No Expectancy and Water Condition | Experimental | Not described Receives: Behavioral: No Expectancy and Water |
| No Water Condition | Experimental | Not described Receives: Behavioral: No Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caloric intake
Weighing food on digital food scale after taste test.
Measured: Through study completion, up to 9 weeks.
Secondary outcomes (4)
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.
Measured: Through study completion, up to 9 weeks.
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).
Measured: Assessed at baseline before any experiment administration.
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).
Measured: Assessed at baseline before any experiment administration.
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."
Measured: Assessed at baseline before any experiment administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study startAug 2021 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Study was never started.
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 Appetitive BehaviorStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737629
- Sponsor's protocol ID
- IRB202001347
- Status last verified
- Aug 2023
- First submitted
- 21 Jan 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31722029Lappalainen 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.
PubMed 8287852Davy 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.
PubMed 18589036Daniels 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.
PubMed 20796216Dennis 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.
PubMed 19661958Corney 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.
PubMed 25893719Stookey 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.
PubMed 26729162Madjd 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.
PubMed 26537940Casazza 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.
PubMed 24950157
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effects of Herbs on Attention, Coordination, and Taste
- ClinicalTrials.gov ID
- NCT04737629
- Acronym / sponsor ID
- IRB202001347
- Conditions
- Appetitive Behavior, Weight Loss, Water, Energy Intake
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Feb 2021 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Expectancy and Water Condition | Experimental | Behavioral: Expectancy and Water |
| No Expectancy and Water Condition | Experimental | Behavioral: No Expectancy and Water |
| No Water Condition | Experimental | Behavioral: No Water |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Expectancy and WaterIn 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). | Behavioural | Expectancy and Water Condition |
| No Expectancy and WaterParticipants 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). | Behavioural | No Expectancy and Water Condition |
| No WaterParticipants 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). | Behavioural | No Water Condition |
Primary outcome
Caloric intake
Time frame: Through study completion, up to 9 weeks.
Weighing food on digital food scale after taste test.
4 secondary outcomes
Appetite
Time frame: Through study completion, up to 9 weeks.
Physical activity
Time frame: Assessed at baseline before any experiment administration.
Restrained eating
Time frame: Assessed at baseline before any experiment administration.
Habitual water intake
Time frame: Assessed at baseline before any experiment administration.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Background: PubMed 31722029Han 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.
- Background: PubMed 8287852Lappalainen 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.
- Background: PubMed 18589036Davy 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.
- Background: PubMed 20796216Daniels 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.
- Background: PubMed 19661958Dennis 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.
- Background: PubMed 25893719Corney 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.
- Background: PubMed 26729162Stookey 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.
- Background: PubMed 26537940Madjd 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.
- Background: PubMed 24950157Casazza 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Expectancy and Water, No Expectancy and Water and No Water in people with Appetitive Behavior and Weight Loss, run by University of Florida.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Caloric intake (time frame: Through study completion, up to 9 weeks.). 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 NCT04737629, 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 28 Aug 2023.