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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

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

Condition or disease Intervention/treatment Phase
Oral Glucose Tolerance Other: aspartame Other: water Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
Actual Study Start Date : August 17, 2016
Actual Primary Completion Date : May 5, 2017
Actual Study Completion Date : May 5, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspartame

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




Primary Outcome Measures :
  1. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 0

  2. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 15 minutes post glucola

  3. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 30 minutes post glucola

  4. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 60 minutes post glucola

  5. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 90 minutes post glucola

  6. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 120 minutes post glucola

  7. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 180 minutes post glucola

  8. change oral glucose tolerance [ Time Frame: week 0 4 hours ]
    sample taken at time point 240 minutes post glucola

  9. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 0

  10. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 15 minutes post glucola

  11. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 30 minutes post glucola

  12. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 60 minutes post glucola

  13. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 90 minutes post glucola

  14. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 120 minutes post glucola

  15. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 180 minutes post glucola

  16. change oral glucose tolerance [ Time Frame: week 12 4 hours ]
    sample taken at time point 240 minutes post glucola


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. Body composition [ Time Frame: week 0 ]
    body composition measurement Plysmography (BOD POD)

  6. Body composition [ Time Frame: week 12 ]
    body composition measurement Plysmography (BOD POD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02999321


Locations
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United States, Indiana
Purdue Univeristy
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Purdue University
Ajinomoto USA, INC.
Investigators
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Principal Investigator: Richard D Mattes, PhD Purdue University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Richard Mattes, Professor of Nutrition Sciences, Purdue University
ClinicalTrials.gov Identifier: NCT02999321    
Other Study ID Numbers: 055-045
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided