NCT02999321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 17, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

9 months

First QC Date

December 19, 2016

Last Update Submit

January 16, 2018

Conditions

Oral Glucose Tolerance

Outcome Measures

Primary Outcomes (16)

  • 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 Outcomes (6)

  • Appetite

    every hour for 1 day at week 0

  • Appetite

    every hour for 1 day at week 4

  • Appetite

    every hour for 1 day at week 8

  • Appetite

    every hour for 1 day at week 12

  • Body composition

    week 0

  • +1 more secondary outcomes

Study Arms (3)

0% aspartame (water)

EXPERIMENTAL

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

Other: water

5 mg aspartame

EXPERIMENTAL

participants will receive 5 mg aspartame in a beverage.

Other: aspartame

15mg aspartame

EXPERIMENTAL

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

Other: aspartame

Interventions

aspartameOTHER

will be given 5mg aspartame or 15 mg aspartame

15mg aspartame5 mg aspartame
waterOTHER

control group

0% aspartame (water)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue Univeristy

West Lafayette, Indiana, 47907, United States

Location

Related Publications (1)

  • 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.

    PMID: 29659969DERIVED

MeSH Terms

Interventions

AspartameWater

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and ProteinsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Richard D Mattes, PhD

    Purdue University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Nutrition Sciences

Study Record Dates

First Submitted

December 19, 2016

First Posted

December 21, 2016

Study Start

August 17, 2016

Primary Completion

May 5, 2017

Study Completion

May 5, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(1)