An interventional study of Prebiotic soda followed by high-fat meal and Control beverage followed by high-fat meal in Healthy Participants, sponsored by Ball State University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Ball State University · Not applicable, Interventional, and Other
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.
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.
Ball State University is the lead sponsor of 13 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
During the prebiotic soda arm, participants will consume prebiotic fiber-enriched soda (Olipop) prior to a high-fat meal.
Other: Prebiotic soda followed by high-fat meal
During the control arm, participants will consume a control beverage consisting of seltzer water, granulated sugar, and maltodextrin prior to a high-fat meal.
Other: Control beverage followed by high-fat meal
Participants will consume 20 oz of Olipop cream soda and then eat a high-fat breakfast (two Jimmy Deans bowls).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through the study completion, up to 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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