The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance

Oral Glucose Tolerance Clinical Trial

Official title:

The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02999321
• Other study ID #: 055-045
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: January 16, 2018
• Start date: August 17, 2016
• Est. completion date: May 5, 2017

Study information

• Verified date: January 2018
• Source: Purdue University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: May 5, 2017
• Est. primary completion date: May 5, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI 18-25

• Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick.

Exclusion Criteria:

Related Conditions & MeSH terms

• Oral Glucose Tolerance

Intervention

Other:
• aspartame
will be given 5mg aspartame or 15 mg aspartame
• water
control group

Locations

Country	Name	City	State
United States	Purdue Univeristy	West Lafayette	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Purdue University	Ajinomoto USA, INC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change oral glucose tolerance	sample taken at time point 0	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 15 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 30 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 60 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 90 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 120 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 180 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 240 minutes post glucola	week 0 4 hours
Primary	change oral glucose tolerance	sample taken at time point 0	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 15 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 30 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 60 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 90 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 120 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 180 minutes post glucola	week 12 4 hours
Primary	change oral glucose tolerance	sample taken at time point 240 minutes post glucola	week 12 4 hours
Secondary	Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.	every hour for 1 day at week 0
Secondary	Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 4
Secondary	Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 8
Secondary	Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 12
Secondary	Body composition	body composition measurement Plysmography (BOD POD)	week 0
Secondary	Body composition	body composition measurement Plysmography (BOD POD)	week 12