Effects of L-citrulline Supplementation on Vascular Function in Metabolic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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Using a double-blind, randomized, placebo-controlled, and parallel design, middle-aged and older women with metabolic syndrome will be randomized into receiving either CIT supplementation (10g/day) or placebo (Microcrystalline Cellulose) for 4 weeks.

The first visit will be approximately 1hr and 30 minutes. The 2nd and 3rd visits will each be approximately 2hrs and 30 minutes, separated by 4 weeks in between each visit. During visits 2 and 3, vascular measurements will be assessed in the fasted state and 30, 60, and 90 minutes after acute glucose ingestion (75g).

Conditions

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Metabolic Syndrome Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment Double (Participant, Investigator) Randomized, double-blind, placebo-controlled, parallel study design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-citrulline

L-citrulline: 10 grams/day

Group Type EXPERIMENTAL

L-Citrulline supplementation

Intervention Type DIETARY_SUPPLEMENT

4 weeks of L-Citrulline supplementation (10 grams/day).

Placebo

Microcrystalline Cellulose

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

4 weeks of microcrystalline Cellulose supplementation.

Interventions

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L-Citrulline supplementation

4 weeks of L-Citrulline supplementation (10 grams/day).

Intervention Type DIETARY_SUPPLEMENT

Placebo

4 weeks of microcrystalline Cellulose supplementation.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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

Minimum Eligible Age

45 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes