Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of Satiety Following Oral Administration of an Erythritol Sweetened Beverage

Conditions
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Satiety in Healthy Volunteers

Intervention / Treatment
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* Dietary Supplement: Erythritol
* Dietary Supplement: Aspartame


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspartame Sweetened Beverage<br>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<br>* Aspartame is a well tolerated, commonly used artificial sweetener.<br>|
| Experimental: Erythritol Sweetened Beverage<br>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<br>* Erythritol is a well tolerated, low calorie sugar alcohol that is becoming more widely used as a sugar substitute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythritol, Satiety Response, Ghrelin