Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

NCT ID: NCT02934321

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-18
• Study Completion Date: 2019-08-23

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.

Conditions

Satiety in Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Aspartame Sweetened Beverage

Volunteers will consume a low-calorie, aspartame sweetened beverage (185 mg aspartame in water) after fasting for 10 hours and abstaining from alcohol, caffeine, and strenuous exercise for 24 hours prior to the visit.

Group Type: ACTIVE_COMPARATOR

Aspartame

Intervention Type: DIETARY_SUPPLEMENT

Aspartame is a well tolerated, commonly used artificial sweetener.

Erythritol Sweetened Beverage

Volunteers will consume an isosweet, compared to aspartame, high osmolar, low-calorie erythritol sweetened beverage (50.8 g erythritol in water, 1.66 Molar) after fasting for 10 hours and abstaining from alcohol, caffeine, and strenuous exercise for 24 hours prior to the visit.

Group Type: EXPERIMENTAL

Erythritol

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Erythritol

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

Intervention Type: DIETARY_SUPPLEMENT

Aspartame

Aspartame is a well tolerated, commonly used artificial sweetener.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark L Brantly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida Clinical Research Center

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB201601141

Identifier Type: -

Identifier Source: org_study_id