Effect of Prebiotic Sodas on Postprandial Levels of GLP-1, PYY, Transit Time and Satiety Levels: A Pilot Study

Olipop, PBC

Status: Enrolling

Conditions: Satiety in Healthy Volunteers

Treatments: Other: Prebiotic Soda - Shelf Stable; Other: Prebiotic Soda - Shelf Stable + Functional Ingredient; Other: Prebiotic Soda - Refrigerated; Other: Control Soda

Study type: Interventional

Funder types: Industry

Identifiers

NCT07362563

INQ-2534

Details and patient eligibility

About

The main objective of this study is to evaluate the acute effects of prebiotic sodas on postprandial levels of glucagon-like peptide-1 (GLP-1), peptide YY (PYY), gastric emptying, and satiety levels in healthy adults.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 4 patient groups, including a placebo group

Control Soda

Placebo Comparator group

Description:

Participants will consume one 12 oz can of a control soda

Treatment:

Other: Control Soda

Prebiotic Soda - Shelf Stable

Experimental group

Description:

Participants will consume one 12 oz can of the shelf stable prebiotic soda

Treatment:

Other: Prebiotic Soda - Shelf Stable

Prebiotic Soda - Refrigerated

Experimental group

Description:

Participants will consume one 12 oz can of the refrigerated prebiotic soda

Treatment:

Other: Prebiotic Soda - Refrigerated

Prebiotic Soda - Shelf Stable + Functional Ingredient

Experimental group

Description:

Participants will consume one 12 oz can of the shelf stable prebiotic soda with an added functional ingredient

Treatment:

Other: Prebiotic Soda - Shelf Stable + Functional Ingredient