- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02934321
Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Aspartame is a well tolerated, commonly used artificial sweetener.
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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.
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Erythritol is a well tolerated, low calorie sugar alcohol that is becoming more widely used as a sugar substitute.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
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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
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0 min, 30 min, 120 min following consumption of test drink
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201601141
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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