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Prebiotic Soda
Prebiotic Soda for Healthy Eating (SODA-SWAP Trial)
N/A
Recruiting
Research Sponsored by Olipop, PBC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, aged 18 to 65 at visit 1a
Be older than 18 years old
Must not have
Gastrointestinal condition that could interfere with absorption of study product
Use of oral or injectable steroids within 90 days of visit 1a
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for time frame of 2 to 3 hours post intervention
Awards & highlights
Summary
This trial will investigate how drinking a low-sugar, high-fiber soda called OLIPOP affects blood sugar levels compared to a regular sugary soda. The study will involve generally healthy adults consuming the
Who is the study for?
This trial is for generally healthy adults interested in the effects of different sodas on blood sugar and appetite. Participants will drink OLIPOP prebiotic soda or traditional cola, then eat a carb-rich meal. They must be available for two clinic visits and consume assigned drinks at home.
What is being tested?
The study compares the impact of OLIPOP, a high fiber prebiotic soda with less sugar, to regular sugary cola on blood glucose levels alone and after eating carbs. It also looks at how these drinks affect hunger, alertness, and total calorie intake over several days.
What are the potential side effects?
Since this trial involves commonly consumed beverages like specialty soda and traditional cola, side effects are expected to be minimal but may include changes in digestion due to fiber content in OLIPOP or sugar-related effects from the cola.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a stomach or intestine condition that affects how my body absorbs medicine.
Select...
I have not used oral or injectable steroids in the last 90 days.
Select...
I cannot drink a 12 oz. soda in 15 minutes.
Select...
I have not had signs of infection in the last 5 days.
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I have not had major surgery or serious injury in the last 60 days.
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I am not pregnant, planning to become pregnant, breastfeeding, and I agree to use contraception during the study.
Select...
My medication affecting blood sugar has been stable for the last 90 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for time frame of 2 to 3 hours post intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for time frame of 2 to 3 hours post intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood Glucose iAUC
Secondary outcome measures
Blood Glucose Cmax
Blood Glucose Dip 2-3 Hours
Blood Glucose Reduction
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Soda consumption with a defined carbohydrate rich mealExperimental Treatment2 Interventions
One 12oz serving of soda consumed with a defined carbohydrate rich meal after a 4 hour fasting period
Group II: Soda consumption in fasted stateExperimental Treatment2 Interventions
One 12oz serving of soda consumed alone after a 4 hour fasting period
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Who is running the clinical trial?
Olipop, PBCLead Sponsor
BioFortisOTHER
35 Previous Clinical Trials
3,822 Total Patients Enrolled
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