Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284462
Recruitment Status : Terminated (Sponsor decision to stop study due to COVID-19 pandemic)
First Posted : February 25, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Tracking Information
First Submitted Date  ICMJE February 19, 2020
First Posted Date  ICMJE February 25, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE January 14, 2020
Actual Primary Completion Date March 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • Sweetness liking [ Time Frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6 ]
    Likert scale, 9 point scale from 1=Dislike extremely to 9=Like extremely
  • Sweetness intensity perception [ Time Frame: Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6 ]
    Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
Dietary compensation for sweetness [ Time Frame: Assessed pre-intervention, then monthly x 6 months ]
3-day diet record to assess calories and intake of total sugar, added sugar, low-/non-calorie sweeteners
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 21, 2020)
  • Aftertaste [ Time Frame: Monthly assessments x 6 months ]
    Scale 1-5, 1=Very unpleasant, 5=Very pleasant
  • Aftertaste description [ Time Frame: Monthly assessments x 6 months ]
    12 description options (ex., sweet, tart, bitter, etc.) or other, check all that apply
  • Likely to buy [ Time Frame: One assessment at end of study, month 6 ]
    Scale from 1-5, 1= Definitely would not buy it, to 5 Definitely would buy it
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
Official Title  ICMJE Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
Brief Summary

This is a double-blind, controlled, parallel, randomized sensory study. The study will consist of two cohorts; habitual regular full-calorie Carbonated Soft Drink (CSD) consumers and habitual low-calorie CSD consumers. Each cohort will be randomized to one of 3 interventions for six months (24 weeks):

  • Intervention 1: Control (full sweetness) beverage
  • Intervention 2: Step-wise sweetness reduction series of beverages
  • Intervention 3: Moderate sweetness (reduced sweetness) beverage

The primary outcome is to assess the perception changes in sweetness (magnitude scale) and sweetness liking (Likert scale) of a test product and a control product over a period of six months. The study endeavors to explore whether consumers of sweetened carbonated beverages can adapt liking to lower sweetness beverages after prolonged exposure of daily consumption of beverages with step-wise reduction of sweetness, or maintenance at reduced (moderate) sweetness.

The secondary outcome will be to assess dietary compensation for sweetness in the step-wise and moderate reduction arms compared to the control arms (the full calorie and low calorie control beverages). Dietary analysis of calories and intakes of total sugar, added sugar, and servings of low-/non-calorie sweeteners will be assessed using a 3-day diet record pre-intervention and monthly for 6 months.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Same packaging for all (cans). Color and flavor matched.
Primary Purpose: Basic Science
Condition  ICMJE Sweetness Liking Adaptation
Intervention  ICMJE Other: Flavored carbonated soft drink (CSD)
1-2 cans/day (330 ml per can)
Study Arms  ICMJE
  • Placebo Comparator: Control beverage for Habitual full-calorie CSD cohort, n=28
    Full sweetness (sugar) for 6 months
    Intervention: Other: Flavored carbonated soft drink (CSD)
  • Placebo Comparator: Control beverage for Habitual low-calorie CSD cohort, n=28
    Full sweetness low calorie sweetener (LCS) with sweetness level matched to the full sweetness sugar control for 6 months
    Intervention: Other: Flavored carbonated soft drink (CSD)
  • Active Comparator: Test beverage 1 for Habitual full-calorie CSD cohort, n=28
    Reduced sweetness (moderate sugar level) for 6 months
    Intervention: Other: Flavored carbonated soft drink (CSD)
  • Active Comparator: Test beverage 1 for Habitual low-calorie CSD cohort, n=28
    Reduced sweetness low calorie sweetener (LCS) with sweetness level matched to the moderate sugar sweetness level for 6 months
    Intervention: Other: Flavored carbonated soft drink (CSD)
  • Active Comparator: Test beverage 2 for Habitual full-calorie CSD cohort, n=28
    Step-wise sweetness reduction over 6 months. Month 1 is the full sweetness sugar control, followed by monthly sweetness reduction. Remains at the reduced sweetness level (moderate sugar level) from months 4-6.
    Intervention: Other: Flavored carbonated soft drink (CSD)
  • Active Comparator: Test beverage 2 for Habitual low-calorie CSD cohort, n=28
    Step-wise sweetness reduction over 6 months. Month 1 is the low calorie sweetener (LCS) sweetness equivalent of the full sweetness sugar control, followed by monthly LCS sweetness reduction (reductions equivalent to the corresponding sugar reduction arm sweetness levels). Remains at the reduced sweetness level (LCS equivalent of moderate sugar sweetness level) from months 4-6.
    Intervention: Other: Flavored carbonated soft drink (CSD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 11, 2020)
170
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2020)
168
Actual Study Completion Date  ICMJE March 11, 2020
Actual Primary Completion Date March 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adults 25-55 years of age
  2. Habitually consume regular or diet carbonated soft drinks (CSD)
  3. Willing and able to consume at least one CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
  4. Willing and able to complete questionnaires regarding dietary intake and sensory perception
  5. Has internet access via computer, phone or other device and is able to maintain internet access throughout the trial in order to complete daily online questionnaires.
  6. Participant is judged to be in good health on the basis of medical history and the general health and lifestyle questionnaire.
  7. Participant is willing to maintain his or her habitual diet, smoking habits and physical activity patterns, including habitual use of study approved medications and/or dietary supplements throughout the study period.
  8. Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigators.

Exclusion Criteria:

  1. Regular smoker (more than 1 cigarette per week)
  2. History or presence of clinically important endocrine (including type 1 or 2 diabetes mellitus), cardiovascular, pulmonary, biliary, renal, hepatic, pancreatic, or neurologic disorders that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
  3. Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
  4. Extreme changes to physical activity
  5. Females who are pregnant, planning to be pregnant during the study period, lactating, or of childbearing potential and unwilling to commit to the use of a medically approved form of contraception throughout the study period.
  6. Recent history (within 12 months of screening; Visit 1) of alcohol or substance abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
  7. Individual has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the participant at undue risk.
  8. Dislike of study product taste
  9. Participation in another clinical trial within past 30 days and participation in a PepsiCo clinical trial in the past 6 months.
  10. People who have phenylketonuria (low calorie sweetened beverages contain aspartame)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04284462
Other Study ID Numbers  ICMJE PEP-1908
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party PepsiCo Global R&D
Study Sponsor  ICMJE PepsiCo Global R&D
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kathleen Kelley, MD Biofortis Innovation Services
PRS Account PepsiCo Global R&D
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP