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 @ 10:12 PM
Ignite Modification Date:
2025-12-24 @ 10:12 PM
NCT ID:
NCT07298135
Eligibility Criteria:
Inclusion Criteria:
* Able to provide informed consent
* Willing to comply with all study procedures
* Ages 40 - 70 years old
* Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings/daily)
* BMI between 25 - 35 kg/m²
* Waist-to-Hip ratio ≥0.85 for Women and ≥0.9 for Men
* Fasting plasma glucose between 100 - 125 mg/dL
* Consumes ≤16 g total fiber per day to align with the current average dietary fiber intake of American adults
* Non-user or former user (cessation ≥ 12 months) of tobacco or nicotine products
* Non-user of marijuana and hemp products, including CBD products, in the previous 60 days
* Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial
Exclusion Criteria:
* Inability to consume a standard 12 fl. oz. carbonated beverage twice daily
* Currently engaged or planning to be on an intensive weight loss regimen program
* Extreme dietary habits or has been diagnosed with an eating disorder
* Habitual use of fiber supplements, inulin-based supplements, acacia fiber, glucomannan, prebiotic supplements, or probiotic supplements within the previous 30 days
* Known allergy or sensitivity to any of the ingredients in the study products
* History or presence of uncontrolled and/or clinically important medical conditions that could interfere with study results interpretation (ex. uncontrolled diabetes mellitus, CKD stage 4-5, severe liver disease/cirrhosis, uncontrolled hypertension, recent myocardial infarction or stroke (within 6 months), severe mental illness or cognitive impairment, immunodeficiency disorders, active infections).
* Gastrointestinal conditions that could potentially interfere with absorption of the study product
* Use of oral or injectable steroids in the previous 90 days
* Use of antibiotic therapy in the previous 90 days
* Unstable use of prescription medications within the previous 90 days that affect plasma glucose levels
* History or presence of cancer, except non-melanoma skin cancer, in the previous 2 years
* Exposure to any non-registered drug product or participation in another intervention study in the previous 30 days
* Recent history (within 12 months) of alcohol or substance abuse
* History of major trauma or surgical event in the previous 60 days
* Person who is pregnant, planning pregnancy, lactating, or unwilling to use contraception during the study period
* Any condition the Investigator believes would interfere with study participation or compliance
* Consumption of pre-biotic sodas in the previous 30 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT07298135
Study Brief:
Protocol Section:
NCT07298135