NCT04737629

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.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2.1 years

First QC Date

January 21, 2021

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Caloric intake

    Weighing food on digital food scale after taste test.

    Through study completion, up to 9 weeks.

Secondary Outcomes (4)

  • Appetite

    Through study completion, up to 9 weeks.

  • Physical activity

    Assessed at baseline before any experiment administration.

  • Restrained eating

    Assessed at baseline before any experiment administration.

  • Habitual water intake

    Assessed at baseline before any experiment administration.

Study Arms (3)

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

Interventions

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).

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 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 Expectancy and Water Condition
No WaterBEHAVIORAL

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).

No Water Condition

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 31722029BACKGROUND
  • 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.

    PMID: 8287852BACKGROUND
  • 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.

    PMID: 18589036BACKGROUND
  • 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.

    PMID: 20796216BACKGROUND
  • 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.

    PMID: 19661958BACKGROUND
  • 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.

    PMID: 25893719BACKGROUND
  • 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.

    PMID: 26729162BACKGROUND
  • 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.

    PMID: 26537940BACKGROUND
  • 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.

    PMID: 24950157BACKGROUND

MeSH Terms

Conditions

Appetitive BehaviorWeight Loss

Interventions

Water

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2021

First Posted

February 4, 2021

Study Start

August 1, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available within 12 months following the completion of the study.
Access Criteria
No access criteria. De-identified data will be available to anyone.