Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT04609657
Eligibility Criteria:
Inclusion Criteria:
1. Healthy adults 25-55 years of age
2. Habitually consume regular or diet CSD
3. Willing and able to consume at least one orange 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 based on a verbal health query 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 type 1 or 2 diabetes mellitus
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, and intermittent fasting (defined as intentional fasting for longer than 16 hours or alternate day fasting)
4. Extreme changes to physical activity
5. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is 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 citrus flavored CSDs
9. Participation in another clinical trial within past 30 days
10. People who have phenylketonuria (low calorie sweetened beverages contain aspartame)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
55 Years
Study:
NCT04609657
Study Brief:
Protocol Section:
NCT04609657