- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872557
Modulating Glucose Tolerance With Dietary Tyrosine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Columbia University Irving Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
i. Inclusion Criteria
- Capable of giving written as well as oral informed consent.
- A fasting plasma glucose level (FPG) < 126 mg/dL (< 7.0 mmol/L) and an Hb1ac in the 5.7-6.4 % range.
- BMI in the range of 18-45 kg/m2.
- Normal Complete blood count (CBC), renal and liver function tests.
ii. Exclusion Criteria:
- Any diabetes medication within previous three (3) months.
- Fasting plasma Glucose (FPG) >126 mg/dl or HbA1c > 6.4%
- Current use (or within 6 months) of antipsychotic, anti-anxiety, or antidepressant medications (e.g. monoamine oxidase (MAO) inhibitors, 5-Hydroxytryptophan (5HT) inhibitors, tricyclic antidepressants, L-DOPA), reserpine, β-2-receptor agonists (e.g., terbutaline), steroids, weight loss medication, anticoagulant medication, over-the-counter nutritional supplements other than standard vitamin and mineral supplements
- History of Phenylketonuria or other inherited disorders of amino acid metabolism.
- History of movement disorder such as Parkinson's disease or Huntington's disease
- Cardiovascular, renal, pulmonary, gastrointestinal, migraines or other medical conditions deemed significant by investigators
- History of/ or psychiatric illness such as major depression, bipolar disease, anxiety or schizophrenia.
- History of bariatric surgery with the exception of gastric band if the band has been removed
- Female of child-bearing age, currently pregnant, breastfeeding or not using a form of birth control.
- Previous or current use of cocaine, methamphetamine, ecstasy (3-4 methylenedioxymethamphetamine (MDMA))
- Current daily intake of caffeine >500 mg/day (>4-5 cups of coffee; >10 12-oz cans of soda)
- Consumption of more than 1 alcoholic drink per day or smoking more than 5 cigarettes/day.
- Systolic Blood Pressure (SBP) > 150 mmHg; Diastolic Blood Pressure (DBP) > 100 mmHg.
- Recent history (in the past three months) of more than a 3% gain or loss in body wt.
- Difficulty in swallowing capsules.
- Concurrent use of antacids or proton pump inhibitors (e.g.,Prilosec Prevacid, dexilant, Aciphex, Protonix, Nexium, Vimovo, Zegerid)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tyrosine (TYR) depletion, then oral TYR
TYR supplementation: Subjects will be directed to avoid consumption of L-DOPA and TYR enriched foods for 48 hours before oral glucose tolerance test (OGTT). On the evening prior to OGTT, subjects will substitute normal meal and snack for three prepackaged tyrosine-phenylalanine-free liquid meals. Visit 2. Placement of intravenous catheter for the collection of serial blood samples and an OGTT with supplementation with oral tyrosine supplement. To supplement the OGTT with Tyrosine, the contents of four (4) L-Tyrosine 500 mg capsule are given 45 minutes before the oral glucose solution is administered. The capsules are to be administered with less than eight ounces of water to minimize dilution of gastric acidity. |
L-Tyrosine dietary supplement will be provided as 500 mg capsules and 4 (four) 500 mg capsules are to be given before OGTT.
The capsules are formed from animal gelatin, and the contents are formulated with magnesium stearate as a flow agent, but without binders, coatings or colorings and also have no added flavorings, sugars, salt, artificial sweeteners, preservatives or salicylates.
The capsules are to be administered with less than eight ounces of water to minimize dilution of gastric acidity.
|
No Intervention: TYR depletion, then no oral TYR
Subjects will be directed to avoid consumption of L-DOPA and TYR enriched foods for 48 hours before OGTT. On the evening prior to OGTT, subjects will substitute normal meal and snack for three prepackaged tyrosine-phenylalanine-free liquid meals. Subsequent Visit 3. This visit will consist of placement of intravenous catheter for the collection of serial blood samples and an OGTT without supplementation with oral tyrosine supplement. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole blood glucose level
Time Frame: Up to 120 minutes from baseline
|
Glucose concentration versus time profile following glucose challenge define glucose tolerance
|
Up to 120 minutes from baseline
|
Plasma insulin concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma insulin concentration versus time profile following glucose challenge define glucose tolerance
|
Up to 120 minutes from baseline
|
Plasma dopamine concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma dopamine concentration versus time profile following glucose challenge may affect glucose tolerance
|
Up to 120 minutes from baseline
|
Plasma L-DOPA concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma L-DOPA concentration versus time profile following glucose challenge may affect glucose tolerance
|
Up to 120 minutes from baseline
|
L-tyrosine concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma L-tyrosine concentration versus time profile following glucose challenge may affect glucose tolerance
|
Up to 120 minutes from baseline
|
Plasma glucagon concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma glucagon concentration versus time profile following glucose challenge impacts glucose tolerance
|
Up to 120 minutes from baseline
|
Plasma GLP-1 concentration
Time Frame: Up to 120 minutes from baseline
|
Plasma GLP-1 concentration versus time profile following glucose challenge impacts glucose tolerance
|
Up to 120 minutes from baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Judith Korner, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAS2124
- R01DK104740 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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