Healthy NutritionSODA-SWAPNCT06427915
Studying Glucose and Appetite Response With Alternatives to Soda Pop
A study testing OLIPOP prebiotic soda and Traditional sugar-sweetened cola in people with Healthy Nutrition, run by Olipop, PBC at 1 site in United States.
Trial summary
The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Nutrition
- What is being tested?
- OLIPOP prebiotic soda and Traditional sugar-sweetened cola
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2024to 21 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, ≥18 to ≤65 years of age at visit 1a.
- Body mass index (BMI) of ≥25.0 kg/m2 to <35.0 kg/m2 at visit 1a.
- Fasting capillary (fingerstick) glucose <126 mg/dL at visit 1a. One repeat will be allowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects are confirmed fasting or a separate day if subjects were not fasting). If a repeat is taken, the second reading will be used to determine eligibility.
- Willing to wear a continuous glucose monitor (CGM) sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
- Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
- Non-user of marijuana and hemp products, including cannabidiol (CBD) products, within 60 d of visit 1a.
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- Willing to avoid alcohol 24 h prior to visit 1a/1b and throughout the study.
- Willing to maintain habitual diet (with the exception of study products) and physical activity patterns throughout the trial.
- Willing to use personal smart phone with operating system (Android version 12.0 or newer; Apple iPhone operating system (iOS) version 16 or newer) capable of downloading the Dexcom G7 CGM app and the Cronometer app for diet records.
- Willing to adhere to all study procedures and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.
Who cannot join
- Inability to consume a standard 12 fl. oz. carbonated beverage with or without food within 15 min.
- Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in the judgment of the Investigator or has been diagnosed with an eating disorder.
- Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 d of visit 1a.
- Known allergy or sensitivity to any of the ingredients in the study products and/or meals provided.
- Weight loss or gain >4.5 kg within 90 d of visit 1a.
- Currently or planning to be on a weight loss or weight gain/ muscle-building regimen program during the study.
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- Use of vitamin C-containing supplements (including multivitamins) within 24 hours of visit 1a and during the study intervention period.
- Shift workers with eating patterns not consistent with the study product consumption schedule.
- History or presence of uncontrolled and/or clinically important endocrine, cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic, dermatologic, rheumatic, and/or biliary conditions that, in the opinion of the Principal Investigator, could interfere with the interpretation of the study results.
- Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at visit 1a.
- Gastrointestinal condition that could potentially interfere with absorption of the study product (e.g., inflammatory bowel syndrome, inflammatory bowel disease (Crohn's or ulcerative colitis), celiac disease, history of gastric bypass surgery).
- Use of oral or injectable steroids (topical and inhaled are allowed) within 90 d of visit 1a.
- Use of products containing salicylic acid (skin-care products are allowed if not used on the area surrounding the CGM sensor) within 24 hours of visit 1a/1b and during the study intervention period. If use occurs during the intervention period (e.g., subject takes an aspirin), details of the use (e.g., time, amount, product) should be documented.
- Unstable use of any prescription medications that affect blood glucose levels, whereby stable is defined as no change in regimen within 90 d prior to visit 1a. Examples include diabetes medications, glucagon-like-peptide-1 (GLP-1) agonists, medications for anxiety, attention deficit/hyperactivity disorder (ADHD), depression, and other mental health problems (e.g., clozapine, olanzapine, quetiapine, and risperidone), thyroid hormone replacement medications, statins, protease inhibitors, adrenergic receptor blockers, and isotretinoin.
- History or presence of cancer, except non-melanoma skin cancer, within 2 years of visit 1a.
- Exposure to any non-registered drug product or has participated in another intervention study within 30 d prior to visit 1a.
- Signs or symptoms of an active infection of clinical relevance within 5 d of visit 1a. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at least 5 d prior to visit 1a.
- Recent history (within 12 months of 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 11⁄2 oz. distilled spirits).
- History of any major trauma or major surgical event within 60 d of visit 1a.
- 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. The method of contraception must be recorded in the source document.
- Any condition the Investigator believes would interfere with his ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Studying GlucOse anD Appetite ResponseS With Alternatives to Pop (SODA-SWAP)
The primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake.
- Conditions
- Healthy Nutrition
- Being tested
- OLIPOP prebiotic soda, Traditional sugar-sweetened cola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLIPOP prebiotic sodaOther
12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus*, Marshmallow Root*, Calendula Flower*, Kudzu Root*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root*, Stevia Leaf*, Himalayan Pink Salt, Green Tea Caffeine*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon* (*Extract)
Traditional sugar-sweetened colaOther
12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine
| Study group | Role | What they receive |
|---|---|---|
| Soda consumption in fasted state | Experimental | One 12oz serving of soda consumed alone after a 4 hour fasting period Receives: Other: OLIPOP prebiotic soda; Other: Traditional sugar-sweetened cola |
| Soda consumption with a defined carbohydrate rich meal | Experimental | One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period Receives: Other: OLIPOP prebiotic soda; Other: Traditional sugar-sweetened cola |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose iAUC
Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence).
Measured: For 2 hours post intervention
Secondary outcomes (10)
Blood Glucose Cmax
Blood glucose maximum concentration
Measured: For 2 hours post intervention
Time to Blood Glucose Cmax (Tmax)
Time to maximum blood glucose concentration
Measured: For 2 hours post intervention
Blood Glucose Rise 0-2 Hours
The maximum concentration above the average baseline glucose concentration within the 2-hour period following study product consumption, expressed as a percentage of the average baseline glucose concentration
Measured: For 2 hours post intervention
Blood Glucose Dip 2-3 Hours
The difference between the lowest glucose concentration in hours 2-3 after study product consumption and the average baseline glucose concentration, expressed as a percentage of average baseline glucose concentration
Measured: For time frame of 2 to 3 hours post intervention
Blood Glucose Reduction
The number of participants with a reduction in glucose in hours 2-3 after study product consumption compared to the average baseline glucose concentration
Measured: For time frame of 2 to 3 hours post intervention
Time Until Next Meal
The number of minutes after consumption of the study product that elapsed before the next meal of at least 50 kcal is consumed
Measured: Within same day post interevention
Energy Intake - Short Term
Energy intake (kcals) within 3 to 4 hours post-product consumption
Measured: For time frame of 3 to 4 hours post intervention
Energy Intake - 24 Hours
The total daily consumption covers the full period from 4 hours before the participant's breakfast to 20 hours after
Measured: Time frame from 4 hours before the participant's breakfast to 20 hours after participant's breakfast
Change in Perceived Hunger Level
The change in hunger ratings from pre-meal to post meal where post meal is defined as the average of the hunger ratings in the 2- 3 hour time frame
Measured: For time frame of 2 to 3 hours post intervention
Change in Perceived Alertness Level
The change in alertness ratings from pre-meal to post meal where the post meal is defined as the average alertness ratings in the 2-3 hour time frame
Measured: For time frame of 2 to 3 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start15 May 2024
- Primary completion21 Jun 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy NutritionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olipop, PBC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427915
- Sponsor's protocol ID
- BIO-2401
- Acronym
- SODA-SWAP
- Status last verified
- Apr 2025
- First submitted
- 16 May 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studying GlucOse anD Appetite ResponseS With Alternatives to Pop (SODA-SWAP)
- ClinicalTrials.gov ID
- NCT06427915
- Acronym / sponsor ID
- SODA-SWAP / BIO-2401
- Conditions
- Healthy Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Olipop, PBCIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- 15 May 2024 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 24 May 2024 (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 primary aim of this clinical trial is to determine the acute effects of OLIPOP (a lower sugar, high fiber prebiotic soda) consumption, compared to consumption of a commercially available sugar-sweetened soda pop, on blood glucose in response to the beverages alone and in combination with a carbohydrate-rich mixed lunch meal in free-living, generally healthy adults.This study will consist of one screening/randomization clinic visit (day 0) and one follow-up clinic visit (day 5), with participants consuming study products on their own (e.g., at home) following an assigned treatment sequence on days 1, 2, 3, and 4. The main questions answered by this trial are the impacts of a prebiotic rich soda versus a traditional soda on: 1) blood glucose levels with and without a meal, 2) perceived hunger levels, 3) perceived alertness levels and 4) total caloric intake.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soda consumption in fasted state | Experimental | Other: OLIPOP prebiotic soda, Other: Traditional sugar-sweetened colaOne 12oz serving of soda consumed alone after a 4 hour fasting period |
| Soda consumption with a defined carbohydrate rich meal | Experimental | Other: OLIPOP prebiotic soda, Other: Traditional sugar-sweetened colaOne 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, ≥18 to ≤65 years of age at visit 1a.
- Body mass index (BMI) of ≥25.0 kg/m2 to <35.0 kg/m2 at visit 1a.
- Fasting capillary (fingerstick) glucose <126 mg/dL at visit 1a. One repeat will be allowed for glucose values between ≥126 and ≤140 mg/dL (same day if subjects are confirmed fasting or a separate day if subjects were not fasting). If a repeat is taken, the second reading will be used to determine eligibility.
- Willing to wear a continuous glucose monitor (CGM) sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
- Non-user or former user (cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period.
Key exclusion criteria (21 listed)
- Inability to consume a standard 12 fl. oz. carbonated beverage with or without food within 15 min.
- Extreme dietary habits (e.g., Atkins diet, very high protein, and/or vegan) in the judgment of the Investigator or has been diagnosed with an eating disorder.
- Habitual (e.g., daily) use of fiber supplements or prebiotic supplements within 30 d of visit 1a.
- Known allergy or sensitivity to any of the ingredients in the study products and/or meals provided.
- Weight loss or gain >4.5 kg within 90 d of visit 1a.
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 |
|---|---|---|
| OLIPOP prebiotic soda12oz serving containing Carbonated Water, OLISMART(TM) (Cassava Root Fiber, Acacia Fiber, Guar Fiber, Nopal Cactus*, Marshmallow Root*, Calendula Flower*, Kudzu Root*), Cassava Root Syrup, Apple Juice Concentrate, Lime Juice, Natural Cola Flavor, Alpinia Galanga Root*, Stevia Leaf*, Himalayan Pink Salt, Green Tea Caffeine*, Natural Caramel Flavor, Natural Vanilla Flavor, Cinnamon* (*Extract) | Other | Soda consumption in fasted state, Soda consumption with a defined carbohydrate rich meal |
| Traditional sugar-sweetened cola12oz serving containing carbonated water, high fructose corn syrup, caramel color, phosphoric acid, natural flavors, caffeine | Other | Soda consumption in fasted state, Soda consumption with a defined carbohydrate rich meal |
Primary outcome
Blood Glucose iAUC
Time frame: For 2 hours post intervention
Incremental area under the curve (iAUC) for glucose from t = -30 min prior to test product consumption to t = 120 min following test-product consumption (iAUC0-120 min), where t = 0 is the start of beverage consumption either alone or in combination with a meal (depending on the test sequence).
10 secondary outcomes
Blood Glucose Cmax
Time frame: For 2 hours post intervention
Time to Blood Glucose Cmax (Tmax)
Time frame: For 2 hours post intervention
Blood Glucose Rise 0-2 Hours
Time frame: For 2 hours post intervention
Blood Glucose Dip 2-3 Hours
Time frame: For time frame of 2 to 3 hours post intervention
Blood Glucose Reduction
Time frame: For time frame of 2 to 3 hours post intervention
Time Until Next Meal
Time frame: Within same day post interevention
Energy Intake - Short Term
Time frame: For time frame of 3 to 4 hours post intervention
Energy Intake - 24 Hours
Time frame: Time frame from 4 hours before the participant's breakfast to 20 hours after participant's breakfast
Change in Perceived Hunger Level
Time frame: For time frame of 2 to 3 hours post intervention
Change in Perceived Alertness Level
Time frame: For time frame of 2 to 3 hours post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OLIPOP prebiotic soda and Traditional sugar-sweetened cola in people with Healthy Nutrition, 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 21 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: finished, as of the sponsor's last update on 15 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose iAUC (time frame: For 2 hours post intervention). 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 15 Apr 2025.