Glucose Metabolism Disorder Clinical Trial
Official title:
Study of the Reversibility of Glucose Intolerance Caused by Chronic Aspartame Consumption
Experiments have shown that some artificial sweeteners like those in diet soda can cause changes in how the body responds to and uses sugar. These changes increase the chance of obesity, type 2 diabetes, and other metabolic diseases. In this study, the investigators plan to see if the most common artificial sweetener, aspartame (brand name Equal, NutraSweet), causes these changes. The investigators believe that if metabolic changes are observed in a person who consumes aspartame, then removing all aspartame from the diet might lead to a reversal of the changes and a normalization of test results.This would impact sweetener additives in our foods and thus decrease the incidence of obesity, diabetes, and the metabolic syndrome.
Experiments have shown that some artificial sweeteners like those in diet soda can cause
changes in how the body responds to and uses sugar. These changes increase the chance of
obesity, type 2 diabetes mellitus, and other metabolic diseases. In this study, the
investigators plan to see if the most commonly used artificial sweetener, aspartame, affects
the body's response to sugar. The investigators believe that if metabolic changes are
observed in a person who consumes aspartame, then removing all aspartame from the diet might
lead to a reversal of the changes and a normalization of test results.
The investigators plan to study two (2) cohorts of healthy volunteers: 1) Those who regularly
drink at least three cans per day of diet soda that contains aspartame (Cohort 1, Aspartame
Consumers) and 2) participants who consume less than or equal to two (2) cans of diet soda
per week (Cohort 2, Aspartame Naïve Participants).
Phase I of the study, the investigators will ask participants questions about their usual
diet, including how much diet soda they usually drink. Participants will be screened by a
test called the oral glucose tolerance test, or OGTT. This test involves coming to the
hospital to drink sugary syrup, then have blood sugar checked every thirty (30) minutes for
five (5) hours. Before the test, participants must refrain from eating or drinking anything
for ten (10) hours. If the OGTT shows a high value, then the participant in cohort 1
(Aspartame Consumers) who regularly drink 3 or more cans per day of diet soda will be
approached about continuing into the second phase of the study. For the participants in
cohort 2 (consume less than or equal to two (2) cans of diet soda per week; Aspartame Naïve
Participants), this will be the end of their participation in the study.
Phase II of the study, blood tests, OGTT, stool samples, and weight and body fat measurements
a few times a week will track any changes in the participants during the study. During the
phase II five (5) week study, participants will receive all of their meals from the
Rockefeller University Hospital and should not have any outside food or drinks. The diet used
throughout this study phase (II) is the Prudent Metabolic Diet. Participants can leave the
hospital and continue to work, but must come for all tests and to receive meals. During Week
One, participants will eat only food provided by the hospital but will continue to drink
three (3) cans of diet soda per day. In Weeks Two through Four, participants will continue to
eat food given to them by the hospital and will not be allowed to consume any foods or drinks
that contain aspartame. In Week Five, participants will continue on the hospital diet, but
will again start drinking three (3) cans of diet soda per day.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00361868 -
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|
Phase 3 |