Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes

NCT ID: NCT04112875

Last Updated: 2019-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-09-30

Brief Summary

This study aims was evaluated the effect of L-arginine on microcirculation, vasoreactivity / endothelial function and vascular smooth muscle of young and old women with Sarcopenia or Type 2 Diabetes Mellitus measured by Nailfold videocapillaroscopy and venous occlusion plethysmography before and after 14 days of consumption 5g oral L-arginine supplementation.

Detailed Description

Aging causes responsible endothelial changes, in part by a decrease in the blood flow of the skeletal muscles of the elderly. Reduction of muscle mass / function (Sarcopenia) and Diabetes Mellitus are frequent pathologies in the elderly. L-Arginine is a semi-essential amino acid precursor to nitric oxide synthesis (NO), an important vasodilator and protector cardiovascular.

Seventy-five women were allocated into three groups: twenty-five healthy young (HY) recruited among University students, and fifty women elderly, this was stratified in twenty-five healthy elderly (HE) control and twenty-five with hyperglycemia (HG) elderly from the ambulatories of the Geriatric and Diabetology at the State University of Rio de Janeiro (UERJ) and private supplementary health program. To control group was considered absence cardiovascular risk factor except advanced age. Participants were subjected to screening phase before being eligible for the study by telephone, which comprised of individual clinical history. All subjects signed the written Informed Consent Form enclosed in the protocol approved by Ethics Committee from the State University of Rio de Janeiro according to Helsinki Declaration.

The subjects elected for research made 4 visits to the Biovasc laboratory for data collection. First day: the protocol was explained and agreement from the voluntary obtained, followed and anamnesis and physical exam that included measure at-rest blood pressure, weight and height. Moreover, women examined after 6 hours fasting the microcirculation function using nailfold vidiocapilaroscopy (NVC), followed of the measure of forearm blood flow (FBF) and vascular reactivity by venous occlusion plethysmography (VOP). Second day: Venous blood sample collection after 12 hours fasting. In sequence, they realized whole-body dual-energy X-ray absorptiometry (DXA) to calculate the body composition main measure lean and fat mass. After, was delivered a box with 14 sachets content 5g L-arginine supplementation, and it was recommended to ingest with water 30 minutes before breakfast during 14 days. Third day: Return after the supplementation to realize measurement weight, and exams NVC and VOP. Fourth day: blood sample were taken after 12 hours fasting under effect of the L-arginine.

Conditions

Aging; Sarcopenia; Type 2 Diabetes; Microcirculation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

L-arginine

L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.

Group Type: ACTIVE_COMPARATOR

L-arginine

Intervention Type: DIETARY_SUPPLEMENT

Handled powdered supplement to be mixed with water, has orange flavor for oral use.

Maltodextrin

Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.

Group Type: PLACEBO_COMPARATOR

Maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.

Interventions

L-arginine

Handled powdered supplement to be mixed with water, has orange flavor for oral use.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin

hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• young women aged between 20 - 30 years, IMC < 24.9 kg/m2
• older women over 65 years healthy, BMI <35 kg/m2.
• Elderly women with or without a preexisting diagnosis of diabetes mellitus with fasting plasma glucose (FPG) > 100 mg/dL were classified into type 2 diabetes mellitus.

Exclusion Criteria

• involved type 1 diabetes mellitus
• insulin use, cognitive impairment
• frailty
• disorders cardiometabolic
• liver and/or kidney dysfunction
• autoimmune diseases
• smoking
• rigorous exercise
• uncontrolled hypertension with pressure level > 140/90 mmHg, with up to two antihypertensive drugs of different classes.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Laboratory for Clinical and Experimental Research on Vascular Biology

UNKNOWN

Sponsor Role: collaborator

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Gerusa Maritimo da Costa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel A Bottino, PhD

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Gerusa M Costa, MSc

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Locations

State University of Rio de Janeiro

Rio de Janeiro, , Brazil

Countries

Brazil

Other Identifiers

Arginine

Identifier Type: -

Identifier Source: org_study_id