Effects of L-citrulline Supplementation on Vascular Function in Metabolic Syndrome
The objective of this project is to provide evidence that L-Citrulline (CIT) supplementation can improve vascular function in the fasted and acute hyperglycemia conditions in middle-aged and older women with metabolic syndrome.
Conditions:
🦠 Metabolic Syndrome 🦠 Menopause
🗓️ Study Start (Actual) 1 January 2023
🗓️ Primary Completion (Estimated) 1 May 2024
✅ Study Completion (Estimated) 1 August 2024
👥 Enrollment (Estimated) 24
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Lubbock, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 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
    • The following are also inclusion criteria's:
    • * Women aged 45-79 years old
    • * Body mass index ≤ 39.9 kg/m2
    • * Sedentary (defined as \< 120 min/week of exercise)
    • * Abstain from any dietary supplements with vascular effects for one month prior to the beginning of the study and until participation in study has terminated.

    Exclusion Criteria:

    • * \< 45 and \> 79 years of age
    • * Use of medications and/or any supplements that may affect outcome variables (such as arginine-containing supplements, nitroglycerin, statin drugs, biguanides, insulin, beta blockers, statins, verapamil)
    • * Systolic blood pressure ≥ 160 mmHg
    • * BMI \> 40 kg/m2
    • * Recent changes in medication (3 months)
    • * Current smoking any tobacco use
    • * Cardiovascular disease, diabetes (Type 1 or 2), and other metabolic or chronic diseases
    • * More than 7 alcoholic drinks/week of consumption
Ages Eligible for Study: 45 Years to 79 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 July 2023
  • First Submitted that Met QC Criteria 29 August 2023
  • First Posted 6 September 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 August 2023
  • Last Update Posted 6 September 2023
  • Last Verified August 2023