Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-05-22
2018-09-30
Brief Summary
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Therefore, the purpose of this investigation is to evaluate how NNS beverage consumption affects energy intake in free-living situations over a span of three days. Through a 3x4 mixed design, participants will be randomized into one of three groups: NNS beverage, NS beverage, or carbonated water (control). Participants will be encouraged to go about their normal daily activities and not change any other aspect except for drink consumption. One baseline and three, 24-hour dietary recalls will be collected over the course of the study to analyze energy intake. The specific aim of this investigation is to determine if caloric compensation occurs during 3-day exposure to NNS beverages.
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Detailed Description
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The first session will occur the week prior to the test days. At this appointment, informed consent will be obtained, a demographic questionnaire completed, a beverage questionnaire (BEVQ-15) completed, and an appropriate time and preferred mode of contact (text message or e-mail) will be collected. Participant's height and weight will be collected through an electronic scale for weight and a stadiometer for height using standard procedures (Lohman, et al., 1988). Next, participants will be given the SenseWear armband. Participants will be instructed to start wearing the armband upon awakening on Monday morning and to wear the arm band on their upper right arm until going to sleep Monday night (wear time should be at least 10 hours per day). Participants will be instructed to continue wearing the armband, in an identical manner as on Monday, on Tuesday, Wednesday, and Thursday. Participants will be instructed to not alter their physical activity from their normal routine from Monday to Thursday.
Participants will be randomized to one of the three groups, Coke (NS), Diet Coke (NNS), or carbonated water (control) using a random numbers table. For this investigation, Coke and Diet Coke will be used due to Coke and Diet Coke ranked number one and two as the most popular beverages in the U.S. from 2010 to 2018 ("Sweet! America's top 10 brands of soda," 2011; "Top 10 Best Selling Soft Drink Brands in The World," 2016). Next, participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water. Next, instructions will be provided to participants on how to complete the 24-hour dietary recalls and a two-dimensional visual aid will be provided to help participants in estimating portion sizes. Participants will also be given a detailed schedule about their study participation.
Participants will be called on Tuesday, Wednesday, and Thursday to complete 24-hour dietary recalls. Participants will be sent daily reminders regarding their recalls and wearing the armband via text or e-mail (participant preferred mode of contact).
A final appointment will be completed on Friday in the HEAL lab. The armband will be returned and downloaded, the final recall will be completed, and participants will be debriefed about the purpose of the study. Participants will not be responsible for paying for the SenseWear Armband if they lose it or damage it. Once all data are collected, participants will be given a $25 gift card for their participation. If a participant cannot come to the lab on the Friday of their final appointment, then the last recall will be collected via phone and the appointment will be rescheduled in order to collect the armband.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SCREENING
NONE
Study Groups
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Nutritive Sweetener
Participants will consume 36 ounces of Coke daily for three consecutive days.
Nutritive Sweetener
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Non-Nutritive Sweetener
Participants will consume 36 ounces of Diet Coke daily for three consecutive days.
Non-Nutritive Sweetener
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Carbonated Water
Participants will consume 36 ounces of carbonated water daily for three consecutive days.
Carbonated Water
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Interventions
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Nutritive Sweetener
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Non-Nutritive Sweetener
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Carbonated Water
Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Individuals with overweight or class I obesity - Body mass index (BMI) range 25-34.9 kg/m2
3. Does not participate in more than 100 minutes of structured, moderate- to high-intensity physical activity weekly
4. Consumes \> 36oz of NS beverages daily as assessed by the Beverage Questionnaire (BEVQ)-15 (Hedrick, et al., 2012) - NS beverages include: 100% fruit juice, sweetened juice beverages, energy and sports drinks, sweetened tea or coffee, and soft drinks.
5. Willing to substitute NS beverages for NNS beverages or carbonated water for a three-day period
6. Able to complete all study days consecutively, with all study days following usual schedules and activities (i.e. not traveling)
7. Report a favorable preference for the beverages involved in the study, with participants rating each beverage item ≥3 on a 5-point Likert scale during the phone screen
8. Reports a usual wake up time of 10:00a.m or earlier on Mondays through Fridays.
9. Reports no known allergic reaction to metal
Exclusion Criteria
2. Report of known reactions to sugar or NNS
18 Years
35 Years
ALL
Yes
Sponsors
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The University of Tennessee, Knoxville
OTHER
Responsible Party
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Hollie Raynor
Major Professor
Principal Investigators
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Hannah S Grider
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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Healthy Eating and Activity Laboratory, University of Tennessee
Knoxville, Tennessee, United States
Countries
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References
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Anton SD, Martin CK, Han H, Coulon S, Cefalu WT, Geiselman P, Williamson DA. Effects of stevia, aspartame, and sucrose on food intake, satiety, and postprandial glucose and insulin levels. Appetite. 2010 Aug;55(1):37-43. doi: 10.1016/j.appet.2010.03.009. Epub 2010 Mar 18.
Appleton KM, Blundell JE. Habitual high and low consumers of artificially-sweetened beverages: effects of sweet taste and energy on short-term appetite. Physiol Behav. 2007 Oct 22;92(3):479-86. doi: 10.1016/j.physbeh.2007.04.027. Epub 2007 Apr 27.
Hedrick VE, Savla J, Comber DL, Flack KD, Estabrooks PA, Nsiah-Kumi PA, Ortmeier S, Davy BM. Development of a brief questionnaire to assess habitual beverage intake (BEVQ-15): sugar-sweetened beverages and total beverage energy intake. J Acad Nutr Diet. 2012 Jun;112(6):840-9. doi: 10.1016/j.jand.2012.01.023.
Lavin JH, French SJ, Read NW. The effect of sucrose- and aspartame-sweetened drinks on energy intake, hunger and food choice of female, moderately restrained eaters. Int J Obes Relat Metab Disord. 1997 Jan;21(1):37-42. doi: 10.1038/sj.ijo.0800360.
Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.
Mojet J, Heidema J, Christ-Hazelhof E. Taste perception with age: generic or specific losses in supra-threshold intensities of five taste qualities? Chem Senses. 2003 Jun;28(5):397-413. doi: 10.1093/chemse/28.5.397.
Overduin J, Collet TH, Medic N, Henning E, Keogh JM, Forsyth F, Stephenson C, Kanning MW, Ruijschop RMAJ, Farooqi IS, van der Klaauw AA. Failure of sucrose replacement with the non-nutritive sweetener erythritol to alter GLP-1 or PYY release or test meal size in lean or obese people. Appetite. 2016 Dec 1;107:596-603. doi: 10.1016/j.appet.2016.09.009. Epub 2016 Sep 9.
Piernas C, Tate DF, Wang X, Popkin BM. Does diet-beverage intake affect dietary consumption patterns? Results from the Choose Healthy Options Consciously Everyday (CHOICE) randomized clinical trial. Am J Clin Nutr. 2013 Mar;97(3):604-11. doi: 10.3945/ajcn.112.048405. Epub 2013 Jan 30.
Sweet! America's top 10 brands of soda. (2011, March 25). Retrieved March 1, 2018, from http://www.nbcnews.com/id/42255151/ns/business-us_business/t/sweet-americas-top-brands-soda/
Top 10 Best Selling Soft Drink Brands in The World. (2016, December 30). Retrieved March 1, 2018, from http://www.worldstopmost.com/2017-2018-2019-2020/products/best-selling-soft-drink-brands-world-cheapest-expensive-top-10-popular-list/
Aging changes in the senses: MedlinePlus Medical Encyclopedia. (n.d.). Retrieved March 1, 2018, from https://medlineplus.gov/ency/article/004013.htm
Other Identifiers
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UTK IRB-18-04475-XP
Identifier Type: -
Identifier Source: org_study_id
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