- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07362563
Effect of Prebiotic Sodas on Postprandial Levels of GLP-1, PYY, Transit Time and Satiety Levels: A Pilot Study
Effect of 3 Different Prebiotic Sodas on Postprandial Levels of GLP-1, PYY, Transit Time and Satiety Levels: An Acute, Randomized Controlled Pilot Study in Healthy Participants
Study Overview
Status
Conditions
Detailed Description
The primary aim of this clinical trial is to evaluate the effects of single-dose prebiotic sodas on on postprandial levels of GLP-1.
Participants (n=15) will be healthy males and healthy, non-pregnant, non-lactating females aged 18-60 years. Participants will consume a single dose of 3 different prebiotic sodas (6 - 9 g dietary fiber and 4 g total sugar per can) and one control soda (0 g dietary fiber and 4 g total sugar per can) in a randomized, crossover design over a period of 4-12 weeks with an interval of at least 1 week and at most 3 weeks between visits.
Secondary outcomes will include evaluating the effects of single-dose consumption of the control and prebiotic sodas on postprandial PYY, gastric emptying, and satiety levels.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Director of Clinical Operations
- Phone Number: 201 416-861-0506
- Email: jcampbell@inquis.com
Study Contact Backup
- Name: Senior Scientist
- Phone Number: 416-861-9782
- Email: alexandrajenkins@inquis.com
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5C 2N8
- Recruiting
- INQUIS Clinical Research
-
Contact:
- Director of Clinical Operations
- Phone Number: 201 416-861-0506
- Email: jcampbell@inquis.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-60 years, inclusive.
- BMI between 18.0 and 30.0 kg/m2.
- Stable weight in the last 3 months (+/-5kg).
- Willing to abstain from unusual strenuous exercise, consuming alcoholic drinks and from taking fiber supplements for 24 hours before study days.
- Willing to refrain from smoking tobacco or e-cigarettes, and using marijuana in any form for 12h before and during study visits.
- Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- Subjects must be eligible to receive income in Canada and be covered by a health insurance plan such as Ontario Health Insurance Plan (OHIP).
Exclusion Criteria:
- Self-reported pregnant or breastfeeding women.
- Subjects with a history of severe food allergies or an allergy to acetaminophen.
- Known history of diabetes, any gastrointestinal disorder that alters the absorption of nutrients, liver disease, or the presence of any health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator (QI).
- Subjects who are currently or in the last 2 months have been on oral or injectable GLP-1 receptor agonist (RA) medications.
- Subjects who consume more than 14 alcoholic drinks per week, or more than 5 alcoholic drinks on any one occasion.
- Subjects who have been on antibiotic therapy in the last 2 months.
- Subjects taking the blood thinning drug warfarin.
- Subjects who are habitual users of the following supplements in the past 30 days: berberine, curcumin, cinnamon, resveratrol, and gardenia.
- Subjects which have undergone major surgery in the last 3 months.
- Unwillingness or inability to comply with experimental procedures and to follow Inquis safety guidelines.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control Soda
Participants will consume one 12 oz can of a control soda
|
Participants will consume one 12 oz can of a control soda that contains 0 g dietary fiber and 4 g total sugar.
|
|
Experimental: Prebiotic Soda - Shelf Stable
Participants will consume one 12 oz can of the shelf stable prebiotic soda
|
Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber and 4 g total sugar.
|
|
Experimental: Prebiotic Soda - Refrigerated
Participants will consume one 12 oz can of the refrigerated prebiotic soda
|
Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 9 g dietary fiber and 4 g total sugar.
|
|
Experimental: Prebiotic Soda - Shelf Stable + Functional Ingredient
Participants will consume one 12 oz can of the shelf stable prebiotic soda with an added functional ingredient
|
Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber, 4 g total sugar, and an added functional ingredient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood GLP-1 iAUC
Time Frame: For 2 hours post intervention
|
Incremental area under the curve (iAUC) for GLP-1 from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.
|
For 2 hours post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood PYY iAUC
Time Frame: For 2 hours post intervention
|
Incremental area under the curve (iAUC) for PYY from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.
|
For 2 hours post intervention
|
|
Gastric Emptying Rate/Transit Time via Acetaminophen
Time Frame: Oral dose of acetaminophen with blood samples taken for 2 hours post intervention
|
Incremental area under the curve (iAUC) for acetaminophen from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.
|
Oral dose of acetaminophen with blood samples taken for 2 hours post intervention
|
|
Change in Perceived Satiety Levels
Time Frame: For 2 hours post intervention
|
The change in perceived satiety levels measured using the Motivation to Eat visual analogue scale (VAS) from immediately prior to test-product consumption (t=0) to t=120 min following test-product consumption.
|
For 2 hours post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Janice Campbell, INQUIS Clinical Research
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INQ-2534
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Satiety in Healthy Volunteers
-
University of FloridaCompletedSatiety in Healthy VolunteersUnited States
-
NW PharmaTech LtdCompletedPK in Healthy VolunteersUnited Kingdom
-
PharmaEssentiaNovotech CROCompletedPK in Healthy VolunteersTaiwan
-
Xencor, Inc.ICON Clinical ResearchCompletedSafety in Healthy VolunteersUnited States
-
Daiichi Sankyo, Inc.CompletedPharmacokinetics in Healthy VolunteersUnited States
-
Abbisko Therapeutics Co, LtdCompletedPharmacokinetics in Healthy VolunteersChina
-
Johns Hopkins UniversityNot yet recruitingPsychedelic Effects in Healthy VolunteersUnited States
-
National Cheng Kung UniversityCompletedVascular Function in Healthy VolunteersTaiwan
-
University Medicine GreifswaldCompletedPharmacokinetic Study in Healthy VolunteersGermany
-
University Medicine GreifswaldCompletedPharmacokinetic Study in Healthy VolunteersGermany
Clinical Trials on Control Soda
-
Olipop, PBCPeople ScienceActive, not recruitingBlood Glucose ControlUnited States
-
George Washington UniversityCompletedObesity | Diabetes
-
University of ArizonaCompleted
-
George Washington UniversityCompletedBreastfeedingUnited States
-
George Washington UniversityCompleted
-
UCSF Benioff Children's Hospital OaklandAlmond Board of CaliforniaCompleted
-
Texas Christian UniversityCompletedOlipop | Poppi | Coca Cola - Classic | Diet CokeUnited States
-
National Institute of Diabetes and Digestive and...Completed
-
University of Colorado, DenverCompletedKidney Transplant; Complications | Metabolic AcidosisUnited States
-
Chulabhorn HospitalCompletedHead and Neck Cancer | Adverse Effect of Radiation Therapy | Radiation- Induced MucositisThailand