Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

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.

Study Overview

• Status: Completed
• Conditions: Satiety in Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Aspartame; Dietary supplement: Erythritol

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: Aspartame; Aspartame is a well tolerated, commonly used artificial sweetener.
Experimental: 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.	Dietary supplement: Erythritol; Erythritol is a well tolerated, low calorie sugar alcohol that is becoming more widely used as a sugar substitute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ghrelin taken over 2 hours post beverage total area under curve (AUC)	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 Outcome Measures

Outcome Measure	Time Frame
Ghrelin minimum concentration	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	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	0 min, 30 min, 120 min following consumption of test drink

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2017
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Ghrelin; Satiety Response; Erythritol
• Additional Relevant MeSH Terms: Vasodilator Agents; Erythritol
• Other Study ID Numbers: IRB201601141

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No