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Completed

NCT Number: NCT02999321

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.

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Key information

Conditions

Oral Glucose Tolerance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

aspartame

Other

will be given 5mg aspartame or 15 mg aspartame

Water

Other

control group

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • Ajinomoto USA, INC.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 21, 2016
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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