Clinical trial NCT02999321: The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Official title: The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Glucose Tolerance
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Ajinomoto USA, INC.
First posted: 2016-12-21
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI 18-25
* Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick.

Exclusion Criteria:

-

Primary outcomes:
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 0 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
measure: change oral glucose tolerance
timeFrame: week 12 4 hours
Secondary outcomes:
measure: Appetite
timeFrame: every hour for 1 day at week 0
measure: Appetite
timeFrame: every hour for 1 day at week 4
measure: Appetite
timeFrame: every hour for 1 day at week 8
measure: Appetite
timeFrame: every hour for 1 day at week 12
measure: Body composition
timeFrame: week 0
measure: Body composition
timeFrame: week 12
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue Univeristy
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.