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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03473678
Other study ID # 121964
Secondary ID
Status Completed
Phase N/A
First received January 31, 2018
Last updated March 14, 2018
Start date February 12, 2014
Est. completion date January 2018

Study information

Verified date March 2018
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study investigates the influence of dietary nitrate supplementation on cardiovascular health and physical and cognitive performance in older adults. Participants will receive both a nitrate containing beetroot juice for 10 days and a nitrate depleted beetroot juice for 10 days


Description:

A recent exciting finding is that dietary nitrate supplementation (in the form of beetroot juice) appears to reduce the amount of oxygen needed to complete moderate intensity walking in healthy, young individuals. Nitrate is known to be converted in the body to nitric oxide (NO), a substance which reduces blood pressure and may affect the energy-producing mechanisms inside muscle cells. Exercise tolerance and muscle function typically declines with age and nitrate supplementation therefore may help improve cardiovascular health and the ability to carry out low-intensity daily activities in aging populations. The purpose of this study is to see if healthy, elderly individuals benefit from beetroot juice intake similarly to the effects seen in young adults. If this is indeed the case, then it may suggest that dietary supplementation with a relatively cheap, widely available, and natural food product may improve the ability of healthy elderly individuals to undergo everyday tasks and ultimately improve their quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2018
Est. primary completion date May 28, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years to 80 Years
Eligibility Inclusion Criteria:

1. 70 - 80 years of age

2. male or female

Exclusion Criteria:

1. involved in regular structured exercise

2. receiving medication for:

- pulmonary conditions

- cardiovascular conditions

- metabolic conditions

- musculoskeletal conditions

- ulcerative colitis

- renal disease

Study Design


Intervention

Dietary Supplement:
Nitrate-rich beetroot juice
concentrated beetroot juice
Nitrate-depleted beetroot juice
concentrated beetroot juice

Locations

Country Name City State
United Kingdom Sport and Health Sciences, University of Exeter Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure Change in blood pressure between interventions 10 days
Secondary Oxygen cost of exercise Change in oxygen consumption during exercise 10 days
Secondary Serial Subtraction test change in performance of the Serial Subtraction test 10 days
Secondary Microbiome change in oral microbiome measured by sequencing bacterial 16S rRNA genes 10 days
Secondary Brain metabolism change in brain metabolites measured measured by 1H MRS 10 days
Secondary 6 minute walk test change in performance of 6 minute walk test 10 days
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