Blood Glucose ControlNCT07298135
A Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults
A study testing Prebiotic Soda in people with Blood Glucose Control, run by Olipop, PBC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Glucose Control
- What is being tested?
- Prebiotic Soda
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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%
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- 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
Who cannot join
- 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, uncontrolled hypertension, recent myocardial infarction or stroke (within 6 months), severe mental illness or cognitive impairment, immunodeficiency disorders, active infections).
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- 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, gastric bypass or other bariatric surgeries, severe IBS, chronic diarrhea or malabsorption syndromes, active diverticulitis)
- 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 inhibitors, ACE inhibitors)
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megha Doshi contact
People Science contact
United States1 site, 1 recruiting
- Recruiting
People Science
Los Angeles, California, 90045
People Science, ps48metabolichealthstudy@peoplescience.health
About this study
Official title: A Randomized, Open-Label, Controlled Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults With Glucose Dysregulation
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.
Read the detailed description
The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation.
Participants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day (24 fl. oz/day), 6 g dietary fiber and 2 - 5 g total sugar per 12 fl. oz can).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.
- Conditions
- Blood Glucose Control
- Being tested
- Prebiotic Soda, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic SodaBehavioural
Participants will replace traditional non-diet sodas in their diet with a prebiotic soda (OLIPOP). Participants will consume 2 cans/day (24 fl. oz/day) that will add 12 g dietary fiber/day to their diet.
Active ControlBehavioural
Participants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be randomized to replace traditional non-diet soda with prebiotic soda Receives: Behavioral: Prebiotic Soda |
| Control Group | Active comparator | Participants will be randomized to continue consumption of traditional non-diet soda. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on Fasting Plasma Glucose
Change in fasting plasma glucose
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Effects on Long-term Glycemic Control
Change in HbA1c
Measured: Baseline to week 8
Effect on insulin sensitivity
Change in fasting plasma insulin
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start17 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Open-Label, Controlled
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olipop, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298135
- Sponsor's protocol ID
- PS48
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Controlled Study to Evaluate the Effects of a Prebiotic Soda on Glycemic Control in Adults With Glucose Dysregulation
- ClinicalTrials.gov ID
- NCT07298135
- Acronym / sponsor ID
- PS48
- Conditions
- Blood Glucose Control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Olipop, PBCIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this clinical trial is to evaluate the effects of replacing traditional non-diet soda with a prebiotic soda (i.e., OLIPOP) over an 8 week period on markers of glucose (blood sugar) control in adults with glucose (blood sugar) dysregulation.
Participants (n=224) will be habitual consumers of traditional non-diet sodas, consuming on average 2-3 servings of non-diet soda daily. Participants will be randomized to either an active control group (continued habitual traditional non-diet soda intake, 2 - 3 servings/day) or a behavioral intervention group (OLIPOP prebiotic soda, 2 cans/day (24 fl. oz/day), 6 g dietary fiber and 2 - 5 g total sugar per 12 fl. oz can).
Secondary outcomes will include evaluating the effects of prebiotic soda consumption on additional markers of metabolic health, including long-term glycemic control and insulin sensitivity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, Open-Label, Controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Prebiotic SodaParticipants will be randomized to replace traditional non-diet soda with prebiotic soda |
| Control Group | Active comparator | Behavioral: Active ControlParticipants will be randomized to continue consumption of traditional non-diet soda. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic SodaParticipants will replace traditional non-diet sodas in their diet with a prebiotic soda (OLIPOP). Participants will consume 2 cans/day (24 fl. oz/day) that will add 12 g dietary fiber/day to their diet. | Behavioural | Intervention |
| Active ControlParticipants will continue to consume their habitual intake (on average 2-3 servings/day) of traditional non-diet soda. | Behavioural | Control Group |
Primary outcome
Effects on Fasting Plasma Glucose
Time frame: Baseline to 8 weeks
Change in fasting plasma glucose
2 secondary outcomes
Effects on Long-term Glycemic Control
Time frame: Baseline to week 8
Effect on insulin sensitivity
Time frame: Baseline to week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megha Doshi contact
People Science contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic Soda in people with Blood Glucose Control, run by Olipop, PBC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megha Doshi (megha@peoplescience.health), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on Fasting Plasma Glucose (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.