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

NCT ID: NCT04755400

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-03-15

Brief Summary

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.

Detailed 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Potassium Nitrate

4 days treatment with 24 mmol potassium nitrate capsules

Group Type: ACTIVE_COMPARATOR

isotonic saline 9%

Intervention Type: OTHER

1 Liter of Isotonic saline administered I.V.

Potassium nitrate

Intervention Type: DIETARY_SUPPLEMENT

24 mmol of Potassium nitrate is the active comparator substance, that is ingested every morning for 4 days before and on the examination day.

Potassium Chloride

4 days treatment 24 mmol potassium chloride capsules

Group Type: PLACEBO_COMPARATOR

isotonic saline 9%

Intervention Type: OTHER

1 Liter of Isotonic saline administered I.V.

Potassium chloride

Intervention Type: DIETARY_SUPPLEMENT

24 mmol of Potassium nitrate is the placebo substance, that is ingested every morning for 4 days before and on the examination day.

Interventions

isotonic saline 9%

1 Liter of Isotonic saline administered I.V.

Intervention Type: OTHER

Potassium nitrate

24 mmol of Potassium nitrate is the active comparator substance, that is ingested every morning for 4 days before and on the examination day.

Intervention Type: DIETARY_SUPPLEMENT

Potassium chloride

24 mmol of Potassium nitrate is the placebo substance, that is ingested every morning for 4 days before and on the examination day.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Sodium Chloride 9%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herning Hospital

OTHER

Sponsor Role: collaborator

Frank Mose

OTHER

Sponsor Role: lead

Responsible Party

Frank Mose

Associate professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jesper N Bech, Ph.D., M.D.

Role: STUDY_DIRECTOR

University of Aarhus

Locations

Godstrup Hospital

Herning, , Denmark

Countries

Denmark

Other Identifiers

AMH-1-2016

Identifier Type: -

Identifier Source: org_study_id