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| Name | Class |
|---|---|
| Ajinomoto USA, INC. | INDUSTRY |
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Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0% aspartame (water) | Experimental | participants will not have any aspartame, this is a control. |
|
| 5 mg aspartame | Experimental | participants will receive 5 mg aspartame in a beverage. |
|
| 15mg aspartame | Experimental | participants will receive 5 mg aspartame in a beverage, and 10mg in capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aspartame | Other | will be given 5mg aspartame or 15 mg aspartame |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Richard D Mattes, PhD | Purdue University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue Univeristy | West Lafayette | Indiana | 47907 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29659969 | Derived | Higgins KA, Considine RV, Mattes RD. Aspartame Consumption for 12 Weeks Does Not Affect Glycemia, Appetite, or Body Weight of Healthy, Lean Adults in a Randomized Controlled Trial. J Nutr. 2018 Apr 1;148(4):650-657. doi: 10.1093/jn/nxy021. |
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| ID | Term |
|---|---|
| D001218 | Aspartame |
| D014867 | Water |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| water | Other | control group |
|
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 |
| 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 |
| D006878 |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |