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Official title A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
ClinicalTrials.gov ID: NCT07298135
What this study is testing
- What it's testing
- The main objective of this study is to evaluate the chronic effects of replacing traditional non-diet soda with a prebiotic soda on biomarkers associated with glycemic control in adults with glucose dysregulation who are habitual consumers of traditional soda.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Able to provide informed consent
- Willing to comply with all study procedures
- Male or female, ages 30 - 70 years old
- Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily in a typical month, representing usual dietary...
- BMI between 25 - 35 kg/m²
You likely can't join if
- 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 in the judgement of the Investigator 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 30...
- 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 (i.e...
See the full eligibility criteria
- Able to provide informed consent
- Willing to comply with all study procedures
- Male or female, ages 30 - 70 years old
- Habitual consumers of traditional non-diet soda (average intake 2 - 3 servings (24-36 fl. oz)/daily in a typical month, representing usual dietary pattern)
- BMI between 25 - 35 kg/m²
- Fasting plasma glucose between 100 - 125 mg/dL or hemoglobin A1c between 5.7% - 6.4%
- Low habitual dietary fiber intake, assessed using a qualitative fiber intake screening questionnaire administered at pre-screening
- Willing to maintain stable tobacco/nicotine use habits established for ≥ 90 days, with no initiation, cessation, or change in frequency during the study period
- Willing to maintain stable marijuana, hemp, and CBD product use habits established for ≥ 60 days, with no initiation, cessation, or change in frequency during the study period
- Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial
- 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 in the judgement of the Investigator 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 30 days of study enrollment
- 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 (i.e., diabetes mellitus, CKD stage 4-5, severe liver disease/cirrhosis...
- Gastrointestinal conditions that could potentially interfere with absorption of the study product (i.e., IBD, celiac disease, short bowel syndrome, chronic pancreatitis, gastroparesis, active peptic ulcer disease...
- Use of oral or injectable steroids within 90 days of enrollment
- Use of antibiotic therapy within 90 days of enrollment
- Unstable use of prescription medications within 90 days of enrollment that affect plasma glucose levels (e.g., corticosteroids, thiazide diuretics, beta-blockers (some types), antipsychotics, tacrolimus, protease...
- Use of any of the following prescription medications within 90 days of enrollment: Metformin, sulfonylureas, GLP-1 agonists, SGLT-2 inhibitors, insulin.
- History or presence of cancer, except non-melanoma skin cancer, within 2 years of enrollment
- Exposure to any non-registered drug product or participation in another intervention study within 30 days prior to enrollment
- Recent history (within 12 months) of alcohol or substance abuse
- History of major trauma or surgical event within 60 days of enrollment
- Person who is pregnant, planning pregnancy, or lactating
- Any condition the Investigator believes would interfere with study participation or compliance
- Consumption of more than 5 prebiotic sodas within the last 30 days prior to enrollment
- Heavy smoker as defined as smoking 20 or more cigarettes per day, or smoked roughly 1 pack a day for 20+ years (more than 20 pack years)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.