Effect of L-arginine on Microcirculation, Myogenesis and Angiogenesis Associated With Aging, Sarcopenia and Diabetes
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|ClinicalTrials.gov Identifier: NCT04112875|
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Aging Sarcopenia Type 2 Diabetes Microcirculation||Dietary Supplement: L-arginine Dietary Supplement: Maltodextrin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of L-arginine Supplementation on Microcirculation, Endothelial Function and Vascular Smooth Muscle of Young, Elderly and Patients With Sarcopenia and Type 2 Diabetes Mellitus|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||September 2019|
Active Comparator: L-arginine
L-arginine supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Dietary Supplement: L-arginine
Handled powdered supplement to be mixed with water, has orange flavor for oral use.
Placebo Comparator: Maltodextrin
Maltodextrin supplementation: 5g/sachet with water 30 minutes before breakfast for 14 days.
Dietary Supplement: Maltodextrin
hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.
- Changes in Microcirculation [ Time Frame: before and after 14 days of intervention ]Assessing microvascular changes in the peripheral circulation by microcirculatory image recordings were used Nailfold vidiocapilaroscopy.
- Changes in Endothelium-dependent and endothelium-independent vasodilation [ Time Frame: before and after 14 days of intervention ]Changes in vasodilatation by endothelial reactivity and smooth muscle responsiveness were assessed by Venous occlusion plethysmography
- Change in metabolic markers [ Time Frame: before and after 14 days of intervention ]Metabolic markers associated with lipid profile (total cholesterol, triglycerides, Low Density Lipoproteins (HDLc) and High Density Lipoproteins (LDLc)); renal profile (urea and creatinine); Glycemic and insulin were analyzed to verify treatment response by comparing the results (mg/dL) before and after oral supplementation in the studied groups.
- change in circulating muscle growth and degradation factors [ Time Frame: before and after 14 days of intervention ]Insulin-like growth factor-I (IGF-I) and follistatin (Fslt-I) growth-associated and (GDF-8 / Myostatin and interleukin 6 (IL-6)) degradation-associated were analyzed to verify response to treatment, comparing results (ng / ml) before and after oral supplementation in the study groups.
- Body composition by DXA [ Time Frame: before of intervention ]The whole-body dual-energy X-ray absorptiometry (DXA) was used to measure appendicular skeletal muscle (ASM) composed lean body mass of arms and legs to calculated skeletal muscle mass index by following formula: ASM/height2.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112875
|State University of Rio de Janeiro|
|Rio de Janeiro, Brazil, 20550900|
|Principal Investigator:||Daniel A Bottino, PhD||State University of Rio de Janeiro|
|Principal Investigator:||Gerusa M Costa, MSc||State University of Rio de Janeiro|