2 Weeks of Citrulline Supplementation on Arterial Function in Postmenopausal Women With Elevated Blood Pressure or Hypertension

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

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-07-01

Brief Summary

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The objective of this project is to elucidate the effect of L-Citrulline (L-CIT) supplementation on vascular function at rest and during rhythmic handgrip exercise and functional sympatholysis via lower-body negative pressure in postmenopausal women with elevated blood pressure and hypertension.

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Detailed Description

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Using a double-blind, randomized, placebo-controlled, and crossover design, overweight or obese postmenopausal women with elevated blood pressure (BP) or hypertension will receive CIT (6 grams/day) or placebo for 2 weeks, separated by a two-week washout period.

There will be a total of 5 laboratory visits. The 1st visit will take approximately 1 hour. The 2nd - 5th visits will take about 2 hours and 15 minutes. Visit 1 will be a screening visit, visits 2 and 4 will be considered baseline visits, and visits 3 and 5 will be following the participants' two weeks of supplementation. Arterial stiffness (carotid-femoral and femoral-dorsalis pedis pulse wave velocity) and endothelial function will be assessed at rest. Additionally, brachial artery blood flow, forearm muscle oxygenation, cardiovascular hemodynamics (stroke volume, cardiac output, systemic vascular resistance), and BP will be assessed at rest, during 6 minutes of rhythmic handgrip exercise at 30% of a predetermined maximal voluntary contraction, and 2 minutes of superimposed lower body negative pressure to increase sympathetic activity.

Conditions

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Menopause Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cross-Over Assignment Double (Participant, Investigator) randomized, double-blind, placebo-controlled, cross-over study design

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L-Citrulline

L-Citrulline: 6 grams/day divided in 2 equal doses

Group Type EXPERIMENTAL

L-Citrulline

Intervention Type DIETARY_SUPPLEMENT

2 weeks of L-Citrulline supplementation (6 grams/day)

Placebo

Microcrystalline cellulose: 8 capsules/day divided into 2 equal doses

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

2 weeks of microcrystalline cellulose supplementation (8 capsules/day)

Interventions

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L-Citrulline

2 weeks of L-Citrulline supplementation (6 grams/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo

2 weeks of microcrystalline cellulose supplementation (8 capsules/day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women (defined as the absence of menstruation for at least 1 year).
* Resting systolic blood pressure 120-150 mmHg.
* Between the ages of 50 - 70 years.
* Sedentary (\< 120 minutes of exercise/week).
* Body mass index of 25 - 39.9 kg/m2.
* Fasting glucose \< 126 mg/dL and HbA1c \< 6.5%.

Exclusion Criteria

* Body mass index ≥ 40 or \< 25 kg/m2.
* Systolic blood pressure \> 150 mmHg.
* Taking more than two antihypertensive medications.
* Cardiovascular diseases, type I/II diabetes, musculoskeletal disorders, or cancer.
* Changes in hypertensive medication in the past three months.
* Began or changed hormone replacement therapy in the past 6 months.
* Current smoker.
* Heavy drinking (\> 7 alcoholic drinks/week).
* Participants on beta-blockers or other vasodilatory supplements (nitrates).
* Incorporated in a weight loss program and/or aerobic or resistance training program.

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes