L-arginine supplementation effect on CVDs.

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT201501183236N6
• Date of registration: 2015-02-01
• Prospective Registration: No
• Primary sponsor: Shiraz University of Medical Sciences
• Public title: L-arginine supplementation effect on CVDs.
• Scientific title: Effect of L-arginine supplementation on biochemical and anthropometirc indices associated with cardiovascular diseases
• Date of first enrolment: 2015-01-20
• Target sample size: 75
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/3313
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
• Phase: 2-3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Zohre Mazloom
• Affiliation: Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences

• Name: Arash Dashtabi
• Affiliation: Shiraz University of Medical Sciences, Faculty of Nutrition and Food Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: both sexes; BMI higher than than 29.9 kg/m2 or visceral obesity (BMI whithin25- 29.9 kg/m2 and wc more than 102 cm in men or more than 88 in women); acute or chronic inflammation; stable body weight 3 months before the start of the study (based on self report) absence of any current diet or supplement treatment; absence of antidiabetic, antihypertensive, antihyperlipidemic treatment; no history of ischemic heart disease; and normal renal and liver function. Exclusion criteria: Unwillingness to continue; the use of tobacco or alcohol during the study; taking any supplements other than the selected intervention; any disease or physiological changes that requires special treatment; failure to follow the intervention designing (not consuming dedicated supplement to the total amount less than 90% predicted or more than 3 days).
Exclusion criteria:

Age minimum: no limit
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity, unspecified

Obesity.
Obesity, unspecified

Intervention(s)

Intervention 1: L-Ariginine
3 g/day
8 weeks. Intervention 2: L-arginine
6 g/day
8 weeks. Intervention 3: placebo
8 weeks.

placebo
8 weeks

L-Ariginine
3 g/day
8 weeks

L-arginine
6 g/day
8 weeks

Placebo

Treatment - Drugs

Primary Outcome(s)

HbA1c. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - percentage.

Skinfold. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: caliper - mm.

LDL. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - milligrams per deciliter.

TG. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - milligrams per deciliter.

HDL. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - milligrams per deciliter.

Weight. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Balance - kg.

Wc. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Tape - cm.

MDA. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - micromol per liter.

Systolic and diastolic blood pressure. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Pressure set manually - mm Hg.

Fbs. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - milligrams per deciliter.

TC. Timepoint: Before the experiment, eight weeks after intervention. Method of measurement: Standard enzymatic method - milligrams per deciliter.

Secondary Outcome(s)

BMI. Timepoint: Before and after intervention. Method of measurement: weight devide into height2.

Source(s) of Monetary Support

Shiraz University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Shiraz University of Medical Sciences