NCT03579043

Brief Summary

The use of non-nutritive sweeteners (NNS) in replacement of nutritive sweeteners (NS) could be a potential weight loss strategy as it may reduce energy intake. One concern with the replacement of NS with NNS is the risk of caloric compensation after consumption of NNS. Most studies have examined the effect of NNS foods and beverages on energy intake in the short-term (one-day or less), with results suggesting lack of compensation in the very short-term (less than one day), and then compensation, or over compensation, when the NNS products are consumed on one day with measures of energy intake taken over 1 to 2 days (Anton et al., 2010; Lavin et al., 1997; Overduin et al., 2016; Appleton et al., 2007; Piernas et al., 2013). Given these mixed results, it is still not clear if NNS foods and beverages are a beneficial strategy for decreasing energy intake. However most studies have been in lab-based settings, in which participants are consuming provided food at specific times. No study has reported on the effect of NNS foods or beverages consumed over several days and energy intake on these days when participants are in free-living situations. 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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 22, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

4 months

First QC Date

June 25, 2018

Last Update Submit

November 17, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

  • Energy compensation including beverages

    Dietary intake and beverages

    3 test days

  • Energy compensation not including beverages

    Dietary intake without beverages included

    3 test days

Study Arms (3)

Nutritive Sweetener

EXPERIMENTAL

Participants will consume 36 ounces of Coke daily for three consecutive days.

Other: Nutritive Sweetener

Non-Nutritive Sweetener

EXPERIMENTAL

Participants will consume 36 ounces of Diet Coke daily for three consecutive days.

Other: Non-Nutritive Sweetener

Carbonated Water

EXPERIMENTAL

Participants will consume 36 ounces of carbonated water daily for three consecutive days.

Other: Carbonated Water

Interventions

Nutritive SweetenerOTHER

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.

Also known as: Coke
Nutritive Sweetener
Non-Nutritive SweetenerOTHER

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.

Also known as: Diet Coke
Non-Nutritive Sweetener
Carbonated WaterOTHER

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.

Also known as: Control
Carbonated Water

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The eligible age range of participants will be 18-35 years. The age range for eligible participants was set because research has shown taste sensitivity declines after the age of 60. In 2001, Mojet and colleagues used sucrose and aspartame to test taste threshold sensitivity in young adults age 19-33 years and elderly adults age 60-75 years. Results showed a decrease in threshold and taste in the elderly adults (Mojet, et al., 2001). Sensitivity to the five basic tastes, sweet, salty, sour, bitter, and umami, begins to decline after the age of 60 ("Aging changes in the senses," n.d.).
  • Individuals with overweight or class I obesity - Body mass index (BMI) range 25-34.9 kg/m2
  • Does not participate in more than 100 minutes of structured, moderate- to high-intensity physical activity weekly
  • 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.
  • Willing to substitute NS beverages for NNS beverages or carbonated water for a three-day period
  • Able to complete all study days consecutively, with all study days following usual schedules and activities (i.e. not traveling)
  • 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
  • Reports a usual wake up time of 10:00a.m or earlier on Mondays through Fridays.
  • Reports no known allergic reaction to metal

You may not qualify if:

  • Report of current dieting or dieting within the past month
  • Report of known reactions to sugar or NNS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Healthy Eating and Activity Laboratory, University of Tennessee

Knoxville, Tennessee, 37996, United States

Location

Related Publications (11)

  • 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.

    PMID: 20303371BACKGROUND

  • 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.

    PMID: 17540414BACKGROUND

  • 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.

    PMID: 22709811BACKGROUND

  • 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.

    PMID: 9023599BACKGROUND

  • Lohman TR, Roche AF, Martorell R. Anthropometric Standardization Reference Manual. Champaign,Illinois: Human Kinetics Books; 1988.

    BACKGROUND

  • 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.

    PMID: 12826536BACKGROUND

  • 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.

    PMID: 27620647BACKGROUND

  • 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.

    PMID: 23364015BACKGROUND

  • 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/

    BACKGROUND

  • 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/

    BACKGROUND

  • Aging changes in the senses: MedlinePlus Medical Encyclopedia. (n.d.). Retrieved March 1, 2018, from https://medlineplus.gov/ency/article/004013.htm

    BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

CokeCarbonated Water

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CoalFossil FuelsComplex MixturesEnergy-Generating ResourcesEnvironmentEnvironment and Public HealthMineral WatersWaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsCarbonated BeveragesBeveragesDiet, Food, and NutritionPhysiological PhenomenaDrinking WaterFood and Beverages

Study Officials

  • Hannah S Grider

    University of Tennessee

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Model Details: To see if caloric compensation occurs during 3-day exposure to non-nutritive sweeteners, a 3x4 mixed factorial design will be used, with a between-subject factor of intervention group (NNS, NS, and control) and within-subject factor of time (baseline, day 1 of beverage exposure, day 2 of beverage exposure, and day 3 of beverage exposure).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Major Professor

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 6, 2018

Study Start

May 22, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)