8 Weeks of L-CIT Supplementation and LIRET on Vascular Function in Hypertensive Postmenopausal Women

NCT05227781 | Completed

• 1 other identifier: IRB2018-463
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this project is to bring forth evidence that L-Citrulline (L-CIT) supplementation and low intensity resistance exercise training (LIRET) alone and combined will improve vascular function and muscle fitness (mass, strength, and exercise performance) in postmenopausal women with hypertension. The investigators' central hypothesis is that adjuvant L-CIT supplementation may synergistically enhance vascular (arterial stiffness, BP, muscle oxygenation, blood flow) and muscular (strength, exercise performance) responses to LIRET in postmenopausal women with hypertension by improving endothelial vasodilatory function.

Conditions

Hypertension; Menopause

Keywords

Endothelial Function; Arterial Stiffness; Muscle Function

Outcome Measures

Primary Outcomes (8)

• Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline only)

  Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline only)

  Endothelial function will be assessed at baseline and after 4 weeks of L-Citrulline supplementation alone using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in endothelial function via brachial artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)

  After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using brachial artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in endothelial function via superficial femoral artery flow-mediated dilation (effects of L-Citrulline combined with low-intensity resistance exercise training)

  After the 4-week assessment, endothelial function will be assessed after 4 additional weeks of L-Citrulline supplementation with combined low-intensity resistance exercise training with the legs using superficial femoral artery flow-mediated dilation. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in arm exercise blood flow (effects of L-Citrulline only)

  Blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in leg exercise blood flow (effects of L-Citrulline only)

  Blood flow will be measured in the superficial femoral arteries during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in arm exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)

  After the 4-week assessment, blood flow will be measured in the brachial artery during low intensity arm exercise. All measurements will be performed using Doppler ultrasound.

  4 weeks

• Changes in leg exercise blood flow (effects of L-Citrulline combined with low-intensity resistance exercise training)

  After the 4-week assessment, blood flow will be measured in the superficial femoral artery during low intensity leg exercise. All measurements will be performed using Doppler ultrasound.

  4 weeks

Secondary Outcomes (18)

• Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline only)

  4 weeks

• Changes in arterial stiffness via arm, leg, and aortic pulse wave velocity (effects of L-Citrulline combined with low-intensity resistance exercise training)

  4 weeks

• Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline only)

  4 weeks

• Changes in aortic hemodynamics using pulse wave analysis (effects of L-Citrulline combined with low-intensity resistance exercise training)

  4 weeks

• Changes in brachial and aortic blood pressure via automated sphygmomanometry (effects of L-Citrulline only)

  4 weeks

Study Arms (2)

L-Citrulline

EXPERIMENTAL

L-Citrulline: 10 grams/day

Dietary Supplement: L-Citrulline

Placebo

PLACEBO COMPARATOR

Maltodextrin: 10 grams/day

Dietary Supplement: Placebo

Interventions

L-Citrulline DIETARY_SUPPLEMENT

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

L-Citrulline

Placebo DIETARY_SUPPLEMENT

8 weeks of Placebo (maltodextrin; 10 grams/day)

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 50-75 years
• Resting systolic BP 120-159 mmHg
• Sedentary (\< 60 min of exercise/week)
• Body mass index of 18.5-39.9 kg/m2)
• Fasting glucose \< 126 mg/dL
• HbA1c \< 6.4%.

You may not qualify if:

• Body mass index ≥ 40 or \< 18.5 kg/m2
• Diagnosed with type 1 or 2 diabetes mellitus
• Cardiovascular diseases
• Systolic blood pressure \> 170 mmHg or on more than two anti-hypertensive medication
• Other chronic diseases such as cancer, asthma, glaucoma, thyroid, kidney, liver and pancreatic disease
• Individuals incorporated in a weight loss program and aerobic or resistance training program
• Heavy smokers (\> 20 cigarettes per day)
• Heavy drinkers (\> 12 alcoholic drinks per week)

Sponsors & Collaborators

• Texas Tech University: lead

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Citrulline

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Arturo Figueroa

  Texas Tech University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, randomized, parallel, placebo-controlled
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Arturo Figueroa, Principal Investigator

Model Details: Double-blind (subject, investigator), randomized, parallel, placebo-controlled

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: February 7, 2022
• Study Start: May 24, 2018
• Primary Completion: January 10, 2022
• Study Completion: January 10, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)