Weight Loss Clinical Trial
Official title:
Understanding the Effects of Herbs on Attention, Coordination, and Taste
NCT number | NCT04737629 |
Other study ID # | IRB202001347 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2021 |
Est. completion date | September 2023 |
Verified date | August 2023 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2023 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caloric intake | Weighing food on digital food scale after taste test. | Through study completion, up to 9 weeks. | |
Secondary | 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. | Through study completion, up to 9 weeks. | |
Secondary | 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). | Assessed at baseline before any experiment administration. | |
Secondary | 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). | Assessed at baseline before any experiment administration. | |
Secondary | 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." | Assessed at baseline before any experiment administration. |
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