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

NCT ID: NCT02999321

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-17

Study Completion Date

2017-05-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Oral Glucose Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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0% aspartame (water)

participants will not have any aspartame, this is a control.

Group Type EXPERIMENTAL

water

Intervention Type OTHER

control group

5 mg aspartame

participants will receive 5 mg aspartame in a beverage.

Group Type EXPERIMENTAL

aspartame

Intervention Type OTHER

will be given 5mg aspartame or 15 mg aspartame

15mg aspartame

participants will receive 5 mg aspartame in a beverage, and 10mg in capsules.

Group Type EXPERIMENTAL

aspartame

Intervention Type OTHER

will be given 5mg aspartame or 15 mg aspartame

Interventions

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aspartame

will be given 5mg aspartame or 15 mg aspartame

Intervention Type OTHER

water

control group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ajinomoto USA, INC.

INDUSTRY

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role lead

Responsible Party

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Richard Mattes

Professor of Nutrition Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard D Mattes, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University

Locations

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Purdue Univeristy

West Lafayette, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29659969 (View on PubMed)

Other Identifiers

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055-045

Identifier Type: -

Identifier Source: org_study_id

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