Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

University of Florida12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Satiety in Healthy Volunteers

Interventions

ErythritolDIETARY_SUPPLEMENT

Erythritol is a well tolerated, low calorie sugar alcohol that is becoming more widely used as a sugar substitute.

AspartameDIETARY_SUPPLEMENT

Aspartame is a well tolerated, commonly used artificial sweetener.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Florida Clinical Research Center

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Ghrelin taken over 2 hours post beverage total area under curve (AUC)

Time frame: 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

Ghrelin minimum concentration

Time frame: 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

Serum insulin concentration

Time frame: 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

Change in hunger rating scale

Time frame: 0 min, 30 min, 120 min following consumption of test drink

Data from ClinicalTrials.gov

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