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

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

Study Overview

• Status: Completed
• Conditions: Oral Glucose Tolerance
• Intervention / Treatment: Other: water; Other: aspartame

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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • West Lafayette, Indiana, United States, 47907
      • Purdue Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0% aspartame (water); participants will not have any aspartame, this is a control.	Other: water; control group
Experimental: 5 mg aspartame; participants will receive 5 mg aspartame in a beverage.	Other: aspartame; will be given 5mg aspartame or 15 mg aspartame
Experimental: 15mg aspartame; participants will receive 5 mg aspartame in a beverage, and 10mg in capsules.	Other: aspartame; will be given 5mg aspartame or 15 mg aspartame

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change oral glucose tolerance	sample taken at time point 0	week 0 4 hours
change oral glucose tolerance	sample taken at time point 15 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 30 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 60 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 90 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 120 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 180 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 240 minutes post glucola	week 0 4 hours
change oral glucose tolerance	sample taken at time point 0	week 12 4 hours
change oral glucose tolerance	sample taken at time point 15 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 30 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 60 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 90 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 120 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 180 minutes post glucola	week 12 4 hours
change oral glucose tolerance	sample taken at time point 240 minutes post glucola	week 12 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.	every hour for 1 day at week 0
Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 4
Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 8
Appetite	questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day	every hour for 1 day at week 12
Body composition	body composition measurement Plysmography (BOD POD)	week 0
Body composition	body composition measurement Plysmography (BOD POD)	week 12

Collaborators and Investigators

• Sponsor: Purdue University
• Collaborators: Ajinomoto USA, INC.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2016
• Primary Completion (Actual): May 5, 2017
• Study Completion (Actual): May 5, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 21, 2016

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 16, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 055-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED