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L-Citrulline Supplementation for Metabolic Syndrome
N/A
Recruiting
Led By Arturo Figueroa
Research Sponsored by Texas Tech University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must present at least 3 of the following 5 cardiometabolic risk factors: Waist circumference ≥88 cm, Fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%, Blood pressure ≥130 mm Hg, Triglyceride ≥ 150 mg/dL, HDL <50 mg/dL
Women aged 45-79 years old
Must not have
< 45 and > 79 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial seeks to prove that a supplement can improve vascular health for women with metabolic syndrome.
Who is the study for?
This trial is for sedentary women aged 45-79 with metabolic syndrome, who don't smoke or drink heavily. They must have at least three of these: a waist size ≥88 cm, fasting glucose between 100-125 mg/dL or HbA1c between 5.7-6.4%, high blood pressure (≥130 mm Hg), high triglycerides (≥150 mg/dL), and low HDL (<50 mg/dL). BMI must be ≤39.9 kg/m2.
What is being tested?
The study tests if L-citrulline supplements can improve blood vessel function in middle-aged and older women with metabolic syndrome, especially when their blood sugar is high after eating. Participants will either receive the supplement or a placebo to compare effects.
What are the potential side effects?
While not specified here, common side effects of L-citrulline may include stomach discomfort, heartburn, changes in urination patterns, or an imbalance in electrolytes if taken excessively.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have at least 3 of these: large waist, high sugar, high blood pressure, high triglycerides, or low HDL.
Select...
I am a woman aged between 45 and 79.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am between 45 and 79 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
24-hour ambulatory blood pressure monitoring
Blood pressure during acute hyperglycemia
Blood pressure in the fasted condition
+11 moreSecondary study objectives
Serum Endothelin-1 levels
Serum Nitric Oxide levels
Serum arginase levels
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Microcrystalline Cellulose
Group II: L-citrullineExperimental Treatment1 Intervention
L-citrulline: 10 grams/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Texas Tech UniversityLead Sponsor
82 Previous Clinical Trials
9,255 Total Patients Enrolled
Arturo FigueroaPrincipal InvestigatorTexas Tech University
5 Previous Clinical Trials
150 Total Patients Enrolled
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