Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

NCT02934321 | Completed

• 1 other identifier: IRB201601141
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Satiety in Healthy Volunteers

Keywords

Erythritol; Satiety Response; Ghrelin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Aspartame Sweetened Beverage

ACTIVE COMPARATOR

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

Erythritol Sweetened Beverage

EXPERIMENTAL

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

Interventions

Erythritol DIETARY_SUPPLEMENT

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

Erythritol Sweetened Beverage

Aspartame DIETARY_SUPPLEMENT

Aspartame is a well tolerated, commonly used artificial sweetener.

Aspartame Sweetened Beverage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Clinical Research Center

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Interventions

Erythritol; Aspartame

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mark L Brantly, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: September 18, 2017
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)