The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance

Study Overview
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Brief Summary
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Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.

Detailed Description
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Participants will be randomly assigned to one of three parallel arms: 0% (water), 5 mg, 15mg aspartame. Participants will have an oral glucose tolerance test at the beginning and end of a 12 week intervention. . Participants will report to the lab weekly for 12 weeks to pick up their next week's intervention products and measurements for body weight, waist circumference, blood pressure and heart rate. They will consume their intervention products daily for 12 weeks. They will record appetite sensations and collect a 24 hour urine sample at weeks 0, 4, 8, and 12.

Official Title
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The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance

Conditions
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Oral Glucose Tolerance

Intervention / Treatment
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* Other: aspartame
* Other: water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 18-25 Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0% aspartame (water)<br>participants will not have any aspartame, this is a control. | Other: water<br>* control group<br>|
| Experimental: 5 mg aspartame<br>participants will receive 5 mg aspartame in a beverage. | Other: aspartame<br>* will be given 5mg aspartame or 15 mg aspartame<br>|
| Experimental: 15mg aspartame<br>participants will receive 5 mg aspartame in a beverage, and 10mg in capsules. | Other: aspartame<br>* will be given 5mg aspartame or 15 mg aspartame<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change oral glucose tolerance | sample taken at time point 0 | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 15 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 30 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 60 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 90 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 120 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 180 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 240 minutes post glucola | week 0 4 hours | 
| change oral glucose tolerance | sample taken at time point 0 | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 15 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 30 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 60 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 90 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 120 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 180 minutes post glucola | week 12 4 hours | 
| change oral glucose tolerance | sample taken at time point 240 minutes post glucola | week 12 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite | questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day. | every hour for 1 day at week 0 | 
| Appetite | questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day | every hour for 1 day at week 4 | 
| Appetite | questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day | every hour for 1 day at week 8 | 
| Appetite | questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day | every hour for 1 day at week 12 | 
| Body composition | body composition measurement Plysmography (BOD POD) | week 0 | 
| Body composition | body composition measurement Plysmography (BOD POD) | week 12 |