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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Control Soda
Other interventionParticipants 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 interventionParticipants 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 interventionParticipants 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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Olipop, PBC
Lead sponsor
INQUIS Clinical Research
Collaborator