Study of the Reversibility of Glucose Intolerance Caused by Chronic Aspartame Consumption

Completed · Not applicable

Conditions studied: Glucose Metabolism Disorder

In brief

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.

Key facts

Study ID: NCT02520258
Run by: Rockefeller University
People needed: 75
Starts: 2015-08-01
Expected to finish: 2019-06-25
Last updated by the study team: 2020-06-04

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female aged 18 - 45
Weight stable for at least 3 months prior to screening (< 5% weight change)
BMI of 21 - 29
Cohort 1 - Aspartame Consumers: Primary dietary sweetener is aspartame; consumes at least 36 ounces of diet soda in which aspartame is a primary ingredient (Diet Coke or Diet Dr Pepper) a day for at least 6 months duration prior to study enrollment (Primary dietary sweetener is aspartame" should be defined as: "840g per week sucrose equivalent from aspartame and less than 280 grams per week sucrose equivalent from all other sweeteners (non-caloric and caloric sweeteners). For reference, one 12oz soda is 40g sucrose equivalent, and one teaspoon (one packet) of artificial sweetener is 4g sucrose equivalent.)"
Cohort 2 - Aspartame Naïve Participants: Consumes less than or equal to 2 cans of diet soda per week
Screening Visit #2 OGTT Outcome:
0-h plasma glucose < 110 mg/dl AND
2-h plasma glucose < 140 mg/dl
Abnormal OGTT during the screening phase of the study (area under curve on the high end of distribution)
Must be able to comply with a metabolic Prudent diet
Willing to fast 10 hours before each OGTT and BodPod
Current level of exercise (aerobic and/or resistance training) must be able to be sustained while an in-patient

You may not qualify if…

Any evidence of US National Cholesterol Education Program Adult Treatment Panel III
Clinical Identification of the Metabolic Syndrome (must have 3 or more of the following risk factors):
Abdominal Obesity, given as a waist circumference:
Men >102 cm (>40 in)
Women > 88 cm (>35 in)
Triglycerides >150 mg/dl
HDL Cholesterol:
Men < 40 mg/dl
Women <50 mg/dl
Blood Pressure >130/ >85 mm Hg
Fasting Glucose > 110 mg/dl
Average systolic blood pressure (SBP) > 150 mmHg and / or diastolic blood pressure (DBP) > 90 mmHG (based on 3 BPs taken at screening visit #1),
LDL-C > 240mg/dl
Triglycerides > 400 mg/dl
Evidence of a liver disorder (ALT > three fold of the ULN)
Evidence of any renal disease
Currently on a weight-loss diet
Diabetes
Self-reported history of thyroid dysfunction
Sugar sweetened beverage consumption (> 84 ounces per week)
Hemoglobin <13.0 g/dl for males and 12.0 g/dl for females
Current, prior (within 2 months), or anticipated use of any of the following medications:
antihyperlipidemic, hyperglycemic medications, Antineoplastics, Antiretrovirals, Selective Serotonin Reuptake Inhibitors, Diuretics, Antihypertensives, Anticonvulsants, Hormone therapy, Birth control
Self-reported antibiotic use within the previous 3 months
Currently pregnant or lactating

Where it is running

The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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