Clinical trial NCT02934321: Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage
Official title: Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety in Healthy Volunteers
Keywords: Erythritol
Satiety Response
Ghrelin
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Erythritol is a low calorie sugar substitute that is being increasingly used to sweeten beverages and other food items. Greater amounts of erythritol are required to reach the sweetness level of a common soft drink as compared to aspartame, resulting in higher osmolarity for the erythritol sweetened beverage. Since associations have been noted between osmolarity and satiety, investigators propose that an erythritol sweetened beverage may enhance satiety more than a beverage sweetened with aspartame.

Detailed description: The effects of an erythritol sweetened beverage on satiety has yet to be specifically explored. In this double-blind, 2-way crossover trial, healthy volunteers will consume one of two beverages on each visit: either an erythritol sweetened beverage or an aspartame sweetened beverage. Both beverages will be prepared to the same level of sweetness.

Timed blood samples will be collected over a period of two hours following consumption of the sweetened beverage. Serum total ghrelin and serum insulin will be measured from all blood samples. A validated hunger scale will be administered three times within the two hour period. Data analysis for all measures will be reported with respect to deviation from the initial baseline measured at time 0.

Eligibility criteria: Inclusion Criteria:

* Healthy
* BMI below 25
* Maintained a stable body weight for at least three months prior to volunteering

Exclusion Criteria:

* Exclude if smoking, substance abuse, have a chronic medical or psychiatric illness, regularly intake medications (except for oral contraceptives), regularly use supplements besides vitamins/minerals, have a history of gastrointestinal or renal disorders, have food allergies, have medical dietary restrictions, or have any abnormalities detected on physical examination indicative of disease.
* Participants must have intact gastrointestinal and kidney function to adequately absorb and eliminate the erythritol. Eligibility will be determined by self-reported medical history, physical examination, and specific questioning to exclude prior renal or Gastrointestinal disease after the informed consent process.
* Exclude if abnormal GI anatomy due to surgery (besides appendix removal) or congenital defect as may impair ghrelin production.
* Exclude if the patient is pregnant, lactating, or planning to become pregnant as erythritol has not been specifically tested in this population.
* Exclude if have a Body Mass Index over 25, as ghrelin as a marker of satiety may not be accurate at high Body Mass Index.

Primary outcomes:
measure: Ghrelin taken over 2 hours post beverage total area under curve (AUC)
timeFrame: 0 min, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min following consumption of test drink
Secondary outcomes:
measure: Ghrelin minimum concentration
timeFrame: 0 min, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min following consumption of test drink
measure: Serum insulin concentration
timeFrame: 0 min, 5 min, 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 120 min following consumption of test drink
measure: Change in hunger rating scale
timeFrame: 0 min, 30 min, 120 min following consumption of test drink
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Clinical Research Center
state: Florida
Study officials:
affiliation: University of Florida
name: Mark L Brantly, MD
role: PRINCIPAL_INVESTIGATOR
References: