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

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ClinicalTrials.gov Identifier: NCT02999321
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Ajinomoto USA, INC.
Information provided by (Responsible Party):
Richard Mattes, Purdue University

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE December 21, 2016
Last Update Posted Date January 18, 2018
Actual Study Start Date  ICMJE August 17, 2016
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 0
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 15 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 30 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 60 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 90 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 120 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 180 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 240 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 0
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 15 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 30 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 60 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 90 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 120 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 180 minutes post glucola
  • change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 240 minutes post glucola
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
change oral glucose tolerance [ Time Frame: 4 hours ]
samples taken at 0, 15, 30, 60, 90, 120, 180and 240 minutes
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
  • Appetite [ Time Frame: every hour for 1 day at week 0 ]
    questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.
  • Appetite [ Time Frame: every hour for 1 day at week 4 ]
    questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
  • Appetite [ Time Frame: every hour for 1 day at week 8 ]
    questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
  • Appetite [ Time Frame: every hour for 1 day at week 12 ]
    questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
  • Body composition [ Time Frame: week 0 ]
    body composition measurement Plysmography (BOD POD)
  • Body composition [ Time Frame: week 12 ]
    body composition measurement Plysmography (BOD POD)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • Appetite [ Time Frame: every hour for 1 day at weeks 0, 4, 8 and 12 ]
    questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day during weeks 0, 4, 8 and 12.
  • Body composition [ Time Frame: week 0 and week 12 ]
    body composition measurement Plysmography (BOD POD) done at week 0 and at week 12.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Official Title  ICMJE The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Oral Glucose Tolerance
Intervention  ICMJE
  • Other: aspartame
    will be given 5mg aspartame or 15 mg aspartame
  • Other: water
    control group
Study Arms  ICMJE
  • Experimental: 0% aspartame (water)
    participants will not have any aspartame, this is a control.
    Intervention: Other: water
  • Experimental: 5 mg aspartame
    participants will receive 5 mg aspartame in a beverage.
    Intervention: Other: aspartame
  • Experimental: 15mg aspartame
    participants will receive 5 mg aspartame in a beverage, and 10mg in capsules.
    Intervention: Other: aspartame
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
93
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2016)
120
Actual Study Completion Date  ICMJE May 5, 2017
Actual Primary Completion Date May 5, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02999321
Other Study ID Numbers  ICMJE 055-045
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Richard Mattes, Purdue University
Study Sponsor  ICMJE Purdue University
Collaborators  ICMJE Ajinomoto USA, INC.
Investigators  ICMJE
Principal Investigator: Richard D Mattes, PhD Purdue University
PRS Account Purdue University
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP