Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Terminated

CT.gov ID

NCT04284462

Collaborator

(none)

170

Enrollment

Location

Arms

1.9

Actual Duration (Months)

90.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sweetness Liking Adaptation	Other: Flavored carbonated soft drink (CSD)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

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

Official Title:

Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Mar 11, 2020

Actual Study Completion Date :

Mar 11, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

Sweetness liking [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 [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

Secondary Outcome Measures

Dietary compensation for sweetness [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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adults 25-55 years of age
Habitually consume regular or diet carbonated soft drinks (CSD)
Willing and able to consume at least one CSD beverage daily for a total of 6 months and abstain from other sweetened beverages
Willing and able to complete questionnaires regarding dietary intake and sensory perception
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.
Participant is judged to be in good health on the basis of medical history and the general health and lifestyle questionnaire.
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.
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:

Regular smoker (more than 1 cigarette per week)
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.
Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
Extreme changes to physical activity
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.
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).
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.
Dislike of study product taste
Participation in another clinical trial within past 30 days and participation in a PepsiCo clinical trial in the past 6 months.
People who have phenylketonuria (low calorie sweetened beverages contain aspartame)