Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

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.

Study Overview

• Status: Terminated
• Conditions: Sweetness Liking Adaptation
• Intervention / Treatment: Other: Flavored carbonated soft drink (CSD)

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Innovation Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control beverage for Habitual full-calorie CSD cohort, n=28; Full sweetness (sugar) for 6 months	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)
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	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)
ACTIVE_COMPARATOR: Test beverage 1 for Habitual full-calorie CSD cohort, n=28; Reduced sweetness (moderate sugar level) for 6 months	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)
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	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)
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.	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)
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.	Other: Flavored carbonated soft drink (CSD); 1-2 cans/day (330 ml per can)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sweetness liking	Likert scale, 9 point scale from 1=Dislike extremely to 9=Like extremely	Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6
Sweetness intensity perception	Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness	Changes over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dietary compensation for sweetness	3-day diet record to assess calories and intake of total sugar, added sugar, low-/non-calorie sweeteners	Assessed pre-intervention, then monthly x 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Aftertaste	Scale 1-5, 1=Very unpleasant, 5=Very pleasant	Monthly assessments x 6 months
Aftertaste description	12 description options (ex., sweet, tart, bitter, etc.) or other, check all that apply	Monthly assessments x 6 months
Likely to buy	Scale from 1-5, 1= Definitely would not buy it, to 5 Definitely would buy it	One assessment at end of study, month 6

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Kathleen Kelley, MD, Biofortis Innovation Services

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2020
• Primary Completion (ACTUAL): March 11, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (ACTUAL): February 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: perception; sensory; adaptation; sweetness; liking; intensity; low calorie sweetener; full sugar; carbonated soft drink; taste; dietary compensation; beverage
• Other Study ID Numbers: PEP-1908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No