The Effect of Orally Administrated Nitrate on Renal Parameters and Systemic Haemodynamics (APNI)

Frank Mose

Status: Completed

Conditions: Hypertension

Treatments: Dietary Supplement: Potassium chloride; Dietary Supplement: Potassium nitrate; Other: isotonic saline 9%

Study type: Interventional

Funder types: Other

Identifiers

NCT04755400

AMH-1-2016

Details and patient eligibility

About

Treatment with nitrate has shown to lower blood pressure in both healthy subjects and hypertensive patients.Beside this nitrate have also shown to decrease arterial stiffness and improve endothelial function.But the effect of nitrate on renal blood flow, kidney function, water and salt balance and vasoactive hormones is still unclear.

Therefore, the purpose of this study is to investigate the effect of orally administered nitrate on these parameters.

This will be done in a double-blinded, placebo-controlled, crossover study. 20 healthy subjects will be treated, in a randomized order, with both potassium nitrate and placebo separated by at least 4 weeks wash-out.

Full description

Inorganic nitrate reduces blood pressure and improves endothelial function in both healthy subjects and hypertensive patients.

This effect is thought to be caused through bioconversion to nitric oxide. Thus improving risk factors of cardiovascular decease by increasing vasodilatation, salt regulation and vasoactive hormones.The purpose of this study is to investigate the effect of inorganic nitrate on kidney function, hormones and circulation, which is still unknown.

The effect of 4 days treatment with 24 mmol potassium nitrate capsules on heart rate, blood pressure, vasoactive hormones and urinary excretion of sodium and water will be measured in a randomized, placebo controlled, double blinded, crossover study in 20 healthy subjects. Each subject attends 2x2 examination days at least 4 weeks apart. The examination days are divided into 8 clearance periods of 30 min. each. The first 3 are baseline periods and in period 4 1 Liter of saline is administered to detect any difference in renal parameters after NaCl load.

If inorganic nitrate supplementation is found to lower blood pressure in addition to favorable renal effects, it could lead to changes in the general treatment of high blood pressure and cardiovascular disease.

Enrollment: 18 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-64 years
• BMI 18,5-30
• Normotensive
• Women must use contraception

Exclusion criteria

• Tobacco smoking (Non-smokers in more than 3 months can be included)
• Medicine- or drug abuse
• Alcohol abuse >7 units for women >14 units for men
• Medical treatment (over the counter medication will evaluated whether or not it is grounds for exclusion) within 2 weeks before the trail period starts except contraception.
• Pregnancy or nursing
• Neoplastic disorders
• Significant clinical signs of heart-, lung-, liver-, kidney-, endocrine- or brain disorders
• Clinically significant abnormal findings in screening blood samples, urine sample or ECG - Donation of blood within 1 month of the first day of investigation.
• Allergy against compounds in investigational medicine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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18 participants in 2 patient groups, including a placebo group

Potassium Nitrate

Active Comparator group

Description:

4 days treatment with 24 mmol potassium nitrate capsules

Treatment:

Dietary Supplement: Potassium nitrate

Other: isotonic saline 9%

Potassium Chloride

Placebo Comparator group

Description:

4 days treatment 24 mmol potassium chloride capsules

Treatment:

Dietary Supplement: Potassium chloride

Other: isotonic saline 9%