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Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04284462
Enrollment
170
Registered
2020-02-25
Start date
2020-01-14
Completion date
2020-03-11
Last updated
2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sweetness Liking Adaptation

Keywords

sweetness, liking, adaptation, intensity, low calorie sweetener, full sugar, carbonated soft drink, sensory, taste, dietary compensation, beverage, perception

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.

Interventions

1-2 cans/day (330 ml per can)

Sponsors

PepsiCo Global R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Same packaging for all (cans). Color and flavor matched.

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Sweetness likingChanges over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6Likert scale, 9 point scale from 1=Dislike extremely to 9=Like extremely
Sweetness intensity perceptionChanges over a period of 6 months, measured at monthly intervals from month 0 (baseline) to month 6Magnitude scale ranging from Barely perceptible to Strongest imaginable sweetness

Secondary

MeasureTime frameDescription
Dietary compensation for sweetnessAssessed pre-intervention, then monthly x 6 months3-day diet record to assess calories and intake of total sugar, added sugar, low-/non-calorie sweeteners

Other

MeasureTime frameDescription
AftertasteMonthly assessments x 6 monthsScale 1-5, 1=Very unpleasant, 5=Very pleasant
Aftertaste descriptionMonthly assessments x 6 months12 description options (ex., sweet, tart, bitter, etc.) or other, check all that apply
Likely to buyOne assessment at end of study, month 6Scale from 1-5, 1= Definitely would not buy it, to 5 Definitely would buy it

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026