Oral Glucose ToleranceNCT02999321
The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
A study testing aspartame and water in people with Oral Glucose Tolerance, run by Purdue University at 1 site in United States.
Trial summary
Assess the impact of chronic use of aspartame on glycemia, appetite and body composition. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Glucose Tolerance
- What is being tested?
- aspartame and water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2016to 5 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-25
- Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Assess the impact of chronic use of aspartame on glycemia, appetite and body composition.
Read the 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.
- Conditions
- Oral Glucose Tolerance
- Being tested
- aspartame, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspartameOther
will be given 5mg aspartame or 15 mg aspartame
waterOther
control group
| Study group | Role | What they receive |
|---|---|---|
| 0% aspartame (water) | Experimental | participants will not have any aspartame, this is a control. Receives: Other: water |
| 5 mg aspartame | Experimental | participants will receive 5 mg aspartame in a beverage. Receives: Other: aspartame |
| 15mg aspartame | Experimental | participants will receive 5 mg aspartame in a beverage, and 10mg in capsules. Receives: Other: aspartame |
What is being measured
The primary outcome is the main question the study is designed to answer.
change oral glucose tolerance
sample taken at time point 0
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 15 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 30 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 60 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 90 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 120 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 180 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 240 minutes post glucola
Measured: week 0 4 hours
change oral glucose tolerance
sample taken at time point 0
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 15 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 30 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 60 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 90 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 120 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 180 minutes post glucola
Measured: week 12 4 hours
change oral glucose tolerance
sample taken at time point 240 minutes post glucola
Measured: week 12 4 hours
Secondary outcomes (6)
Appetite
questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day.
Measured: every hour for 1 day at week 0
Appetite
questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
Measured: every hour for 1 day at week 4
Appetite
questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
Measured: every hour for 1 day at week 8
Appetite
questionnaire on hunger, fullness, desire to eat, prospective consumption, thirst taken hourly for one day
Measured: every hour for 1 day at week 12
Body composition
body composition measurement Plysmography (BOD POD)
Measured: week 0
Body composition
body composition measurement Plysmography (BOD POD)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study start17 Aug 2016
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Glucose ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Responsible party
- Principal investigator, Richard Mattes, Purdue University
- Investigators
- Richard D Mattes, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999321
- Sponsor's protocol ID
- 055-045
- Status last verified
- Jan 2018
- First submitted
- 19 Dec 2016
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 29659969
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Aspartame on Appetite, Body Composition and Oral Glucose Tolerance
- ClinicalTrials.gov ID
- NCT02999321
- Acronym / sponsor ID
- 055-045
- Conditions
- Oral Glucose Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Study start
- 17 Aug 2016 (actual)
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0% aspartame (water) | Experimental | Other: waterparticipants will not have any aspartame, this is a control. |
| 5 mg aspartame | Experimental | Other: aspartameparticipants will receive 5 mg aspartame in a beverage. |
| 15mg aspartame | Experimental | Other: aspartameparticipants will receive 5 mg aspartame in a beverage, and 10mg in capsules. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18-25
- Fasting blood sugar between 72 and 108 mg/dl via capillary finger-stick.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspartamewill be given 5mg aspartame or 15 mg aspartame | Other | 15mg aspartame, 5 mg aspartame |
| watercontrol group | Other | 0% aspartame (water) |
Primary outcome
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
6 secondary outcomes
Appetite
Time frame: every hour for 1 day at week 0
Appetite
Time frame: every hour for 1 day at week 4
Appetite
Time frame: every hour for 1 day at week 8
Appetite
Time frame: every hour for 1 day at week 12
Body composition
Time frame: week 0
Body composition
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Derived from this study: PubMed 29659969Higgins 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard D Mattes, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspartame and water in people with Oral Glucose Tolerance, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change oral glucose tolerance (time frame: week 0 4 hours). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02999321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.