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

NCT02520258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Glucose Metabolism Disorder

Interventions

OTHER

Oral glucose tolerance test (OGTT)

OGTT will be conducted following a ten (10) hour fast on Screening Visit 2 (Screening Visit 2 may be conducted between Day -42 to Day 1).

OTHER

Diet soda containing aspartame only

7 days of 36 oz diet soda po daily (Week 1), followed by 21 days washout (Weeks 2-4), and 7 days rechallenge (Week 5); Prudent metabolic diet; Oral glucose tolerance test (OGTT) on days (+/-2) 3, 7, 10, 14, 21, 28, 31, 35

Sponsors & Collaborators

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Thomas Huber, MD PhD · Rockefeller University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2019-06-25
Completion
2019-06-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02520258 on ClinicalTrials.gov