Status:
TERMINATED
Liking Adaptation to Beverages of Varying Sweetness Levels After Prolonged Exposure
Lead Sponsor:
PepsiCo Global R&D
Conditions:
Sweetness Liking Adaptation
Eligibility:
All Genders
25-55 years
Phase:
NA
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-calo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2020
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04284462
Start Date
January 14 2020
End Date
March 11 2020
Last Update
June 16 2020
Active Locations (1)
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1
BioFortis Innovation Services
Addison, Illinois, United States, 60101