Healthy ParticipantsNCT07882264
Fiber Soda on Postprandial Risk Factors
A study testing Prebiotic soda followed by high-fat meal in people with Healthy Participants, run by Ball State University at 1 site in United States.
Trial summary
We are examining whether consuming a fiber-enriched soda (Olipop) before a high-fat meal leads to a more favorable cardiometabolic response than when consuming a control beverage before the same high-fat meal. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Prebiotic soda followed by high-fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 Dec 2027
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are 18-50 years old
- BMI is between 18.5-35.0 kg/m2 - this BMI requirement is due to our research aims.
- You are not pregnant or expecting to become pregnant (females only).
- You are not postmenopausal (females only).
- You have not been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
- You have not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
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- You do not regularly take anti-inflammatory drugs (more than 2x week) or are able to temporarily suspend use of anti-inflammatory drugs.
- You do not use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs.
- You do not have a pacemaker.
- You do not have dietary restrictions prohibiting you from eating the provided meal (e.g., food allergies/intolerance to beef or sweet potato).
- You have not used antibiotics or probiotics in the last month (probiotic containing foods like yogurt are allowed).
- You do not use weight-loss medications (e.g., Ozempic, Wegovy)
- You have not had any surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass).
Who cannot join
- You are not 18-50 years old.
- Your BMI is <18.5 or > 35.0 kg/m2 - this BMI requirement is due to our research aims
- You are pregnant or expecting to become pregnant (females only).
- You are postmenopausal (females only).
- You have been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
- You have been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
Show all 13Show fewer
- You regularly take anti-inflammatory drugs (more than 2x week) or are unable to temporarily suspend use of anti-inflammatory drugs.
- You use lipid-lowering drugs (e.g., statins), glucose-lowering drugs (e.g., metformin) tobacco products, or any illicit drugs
- You have a pacemaker.
- You do have dietary restrictions prohibiting you from eating the provided meal (e.g., food allergies/intolerance to beef or sweet potato).
- You have used antibiotics or probiotics in the last month.
- You use weight-loss medications (e.g., Ozempic, Wegovy).
- You have had a surgery that alters the stomach/gastrointestinal tract (e.g., gastric sleeve, gastric bypass).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Health Professions Building, Ball State University
Muncie, Indiana, 47306
Bryant Keirns, PhD, 765-285-8356, bryant.keirns@bsu.edu
About this study
Official title: Effects of Fiber-Enriched Soda on Postprandial Heart Disease Risk Factors
We are examining whether consuming a fiber-enriched soda (Olipop) before a high-fat meal leads to a more favorable cardiometabolic response than when consuming a control beverage before the same high-fat meal.
Read the detailed description
This study will have the following components:
Prescreening (~5 minutes virtually) Screening visit (30 minutes in lab) Study visit #1 (4.5 hours in lab) Study visit #2 (4.5 hours in lab)
Procedures associated with each study component are listed below.
Prescreening:
We will recruit between 20 and 30 participants for this study (even distribution of males/females). Individuals responding to study recruitment efforts (e.g., flyers, email, announcements) will be asked questions about inclusion/ exclusion criteria. At this point, we will save these interested individuals' email addresses/phone numbers and store them with their name on Ball State's OneDrive (password protected).
Screening Visit:
At the screening visit, we will explain all study procedures to participants and allow them to ask questions. If they are interested in participating in the study, we will obtain written informed consent. Next, we will perform several one-time measurements, including:
Height and weight using a stadiometer and our InBody bioimpedance scale to calculate body mass index (BMI).
Blood pressure using an automated cuff.
Waist circumference using a Gulick tape measurer.
Lastly, we will schedule participants' next two visits (study visit 1 and 2). The study visits will take place from ~6:00am-9:00am, approximately one week apart. We will also give participants a physical activity tracking Garmin watch (vivosmart 5) to wear 4-days leading up to each study visit and a one-day food record (paper or fillable electronic copy). Our watches do not have GPS capabilities; participants will not be tracked.
Visits 1 and 2:
Procedures for visits 1 and 2 will be identical other than the drink consumed with the high-fat meal. The drink will either be 18 oz of Ollipop cream soda (1.5 cans). The control drink will be 18 oz water with 4.5 grams of added cane sugar and 20.5 grams of maltodextrin (an inert carbohydrate source). These modifications will be made to the control water-based beverage to ensure that total sugar and calories are identical to the Ollipop drink. For both visits, participants will arrive having fasted for ~10 hours, avoided exercise and alcohol for >24 hours, and avoided anti-inflammatory medications for > 72 hours. Upon arrival, an indwelling intravenous catheter (IV) will be inserted into a forearm vein and we will obtain a baseline blood sample. Next participants will have 5 minutes to drink the beverage (Ollipop or control), then will be asked to eat a high-fat meal (two Jimmy Dean's breakfast bowls). We have used this meal in the past and it has been well tolerated. Participant will have 20 minutes to consume both breakfast bowls. Research assistants will inform the participant what time the meal should be finished when the participant begins eating and provide periodic time updates. After the meal, we will collect blood samples at 0.5-, 1-, 2-, 3-, and 4-hours post-meal. Each blood draw will be 15 mL. We will centrifuge blood samples to obtain serum. Serum will be used to measure biomarkers listed later in this record.
- Conditions
- Healthy Participants
- Being tested
- Prebiotic soda followed by high-fat meal, Control beverage followed by high-fat meal
- Keywords
- Olipop, Prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic soda followed by high-fat mealOther
Participants will consume 20 oz of Olipop cream soda and then eat a high-fat breakfast (two Jimmy Deans bowls).
Control beverage followed by high-fat mealOther
Participants will consume a control beverage (seltzer water with identical sugar and calories to Olipop drink) and then eat a high-fat breakfast (two Jimmy Deans bowls).
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic Soda Consumption | Experimental | During the prebiotic soda arm, participants will consume prebiotic fiber-enriched soda (Olipop) prior to a high-fat meal. Receives: Other: Prebiotic soda followed by high-fat meal |
| Control Beverage | Active comparator | During the control arm, participants will consume a control beverage consisting of seltzer water, granulated sugar, and maltodextrin prior to a high-fat meal. Receives: Other: Control beverage followed by high-fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides
The investigators will measure triglycerides at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
sCD14
The investigators will measure soluble CD14 at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through study completion, up to 1 year.
LBP
The investigators will measure LBP at baseline and 30-, 60-, 120-, 180-, 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
HDL-C
The investigators will measure HDL-C at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
Glucose
The investigators will measure glucose at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
ApoB
The investigators will measure ApoB at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
Insulin
The investigators will measure insulin at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Measured: Through the study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 May 2026
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ball State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryant Keirns, Ball State University
- Investigators
- Bryans Keirns, Principal Investigator, Principal investigator, Ball State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882264
- Sponsor's protocol ID
- IRB-FY2026-401
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Fiber-Enriched Soda on Postprandial Heart Disease Risk Factors
- ClinicalTrials.gov ID
- NCT07882264
- Acronym / sponsor ID
- IRB-FY2026-401
- Conditions
- Healthy Participants
- Keywords
- Olipop, Prebiotic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ball State UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Oct 2026 (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.
We are examining whether consuming a fiber-enriched soda (Olipop) before a high-fat meal leads to a more favorable cardiometabolic response than when consuming a control beverage before the same high-fat meal.
Detailed description
This study will have the following components:
Prescreening (~5 minutes virtually) Screening visit (30 minutes in lab) Study visit #1 (4.5 hours in lab) Study visit #2 (4.5 hours in lab)
Procedures associated with each study component are listed below.
Prescreening:
We will recruit between 20 and 30 participants for this study (even distribution of males/females). Individuals responding to study recruitment efforts (e.g., flyers, email, announcements) will be asked questions about inclusion/ exclusion criteria. At this point, we will save these interested individuals' email addresses/phone numbers and store them with their name on Ball State's OneDrive (password protected).
Screening Visit:
At the screening visit, we will explain all study procedures to participants and allow them to ask questions. If they are interested in participating in the study, we will obtain written informed consent. Next, we will perform several one-time measurements, including:
Height and weight using a stadiometer and our InBody bioimpedance scale to calculate body mass index (BMI).
Blood pressure using an automated cuff.
Waist circumference using a Gulick tape measurer.
Lastly, we will schedule participants' next two visits (study visit 1 and 2). The study visits will take place from ~6:00am-9:00am, approximately one week apart. We will also give participants a physical activity tracking Garmin watch (vivosmart 5) to wear 4-days leading up to each study visit and a one-day food record (paper or fillable electronic copy). Our watches do not have GPS capabilities; participants will not be tracked.
Visits 1 and 2:
Procedures for visits 1 and 2 will be identical other than the drink consumed with the high-fat meal. The drink will either be 18 oz of Ollipop cream soda (1.5 cans). The control drink will be 18 oz water with 4.5 grams of added cane sugar and 20.5 grams of maltodextrin (an inert carbohydrate source). These modifications will be made to the control water-based beverage to ensure that total sugar and calories are identical to the Ollipop drink. For both visits, participants will arrive having fasted for ~10 hours, avoided exercise and alcohol for >24 hours, and avoided anti-inflammatory medications for > 72 hours. Upon arrival, an indwelling intravenous catheter (IV) will be inserted into a forearm vein and we will obtain a baseline blood sample. Next participants will have 5 minutes to drink the beverage (Ollipop or control), then will be asked to eat a high-fat meal (two Jimmy Dean's breakfast bowls). We have used this meal in the past and it has been well tolerated. Participant will have 20 minutes to consume both breakfast bowls. Research assistants will inform the participant what time the meal should be finished when the participant begins eating and provide periodic time updates. After the meal, we will collect blood samples at 0.5-, 1-, 2-, 3-, and 4-hours post-meal. Each blood draw will be 15 mL. We will centrifuge blood samples to obtain serum. Serum will be used to measure biomarkers listed later in this record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic Soda Consumption | Experimental | Other: Prebiotic soda followed by high-fat mealDuring the prebiotic soda arm, participants will consume prebiotic fiber-enriched soda (Olipop) prior to a high-fat meal. |
| Control Beverage | Active comparator | Other: Control beverage followed by high-fat mealDuring the control arm, participants will consume a control beverage consisting of seltzer water, granulated sugar, and maltodextrin prior to a high-fat meal. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- You are 18-50 years old
- BMI is between 18.5-35.0 kg/m2 - this BMI requirement is due to our research aims.
- You are not pregnant or expecting to become pregnant (females only).
- You are not postmenopausal (females only).
- You have not been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
Key exclusion criteria (13 listed)
- You are not 18-50 years old.
- Your BMI is <18.5 or > 35.0 kg/m2 - this BMI requirement is due to our research aims
- You are pregnant or expecting to become pregnant (females only).
- You are postmenopausal (females only).
- You have been diagnosed with a cardiometabolic condition (e.g., cardiovascular disease, type 2 diabetes)
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 soda followed by high-fat mealParticipants will consume 20 oz of Olipop cream soda and then eat a high-fat breakfast (two Jimmy Deans bowls). | Other | Prebiotic Soda Consumption |
| Control beverage followed by high-fat mealParticipants will consume a control beverage (seltzer water with identical sugar and calories to Olipop drink) and then eat a high-fat breakfast (two Jimmy Deans bowls). | Other | Control Beverage |
Primary outcome
Triglycerides
Time frame: Through the study completion, up to 1 year
The investigators will measure triglycerides at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
sCD14
Time frame: Through study completion, up to 1 year.
The investigators will measure soluble CD14 at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
LBP
Time frame: Through the study completion, up to 1 year
The investigators will measure LBP at baseline and 30-, 60-, 120-, 180-, 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
HDL-C
Time frame: Through the study completion, up to 1 year
The investigators will measure HDL-C at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Glucose
Time frame: Through the study completion, up to 1 year
The investigators will measure glucose at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
ApoB
Time frame: Through the study completion, up to 1 year
The investigators will measure ApoB at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
Insulin
Time frame: Through the study completion, up to 1 year
The investigators will measure insulin at baseline and 30-, 60-, 120-, 180-and 240-minutes after each meal. These measurements will take place immediately and a complete dataset will be compiled upon study completion.
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 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Bryans Keirns, Principal Investigator principal investigator
Ball State University
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 followed by high-fat meal in people with Healthy Participants, run by Ball State University 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 13 inclusion and 13 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 20 Oct 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 Bryant Keirns, Principal Investigator (765-285-8356, bryant.keirns@bsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides (time frame: Through the study completion, up to 1 year). The study lists 7 primary outcomes in all. 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 20 Oct 2026.