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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOlipop, PBC

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Control Soda

    Other intervention

    Participants will consume one 12 oz can of a control soda that contains 0 g dietary fiber and 4 g total sugar.

  • Prebiotic Soda - Shelf Stable

    Other intervention

    Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 6 g dietary fiber and 4 g total sugar.

  • Prebiotic Soda - Refrigerated

    Other intervention

    Participants will consume one 12 oz can of a shelf stable prebiotic soda that contains 9 g dietary fiber and 4 g total sugar.

  • Prebiotic Soda - Shelf Stable + Functional Ingredient

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 4 treatment groups
Group A: Control SodaPlacebo comparator 1 intervention
Group B: Prebiotic Soda - Shelf StableExperimental treatment 1 intervention
Group C: Prebiotic Soda - RefrigeratedExperimental treatment 1 intervention
Group D: Prebiotic Soda - Shelf Stable + Functional IngredientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood GLP-1 iAUC

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.

Time frame
For 2 hours post intervention

Secondary outcomes

1

Blood PYY iAUC

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.

Time frame
For 2 hours post intervention
2

Gastric Emptying Rate/Transit Time via Acetaminophen

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.

Time frame
Oral dose of acetaminophen with blood samples taken for 2 hours post intervention
3

Change in Perceived Satiety Levels

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.

Time frame
For 2 hours post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olipop, PBC

Lead sponsor

INQUIS Clinical Research

Collaborator