- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03473678
Dietary Nitrate and Healthy Older Adults
March 14, 2018 updated by: University of Exeter
Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
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
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Devon
-
Exeter, Devon, United Kingdom, EX12LU
- Sport and Health Sciences, University of Exeter
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years to 80 years (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 70 - 80 years of age
- male or female
Exclusion Criteria:
- involved in regular structured exercise
receiving medication for:
- pulmonary conditions
- cardiovascular conditions
- metabolic conditions
- musculoskeletal conditions
- ulcerative colitis
- renal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Nitrate-rich beetroot juice
2 x 70mL concentrated juice per day for 10 days
|
concentrated beetroot juice
|
PLACEBO_COMPARATOR: Nitrate-depleted beetroot juice
2 x 70mL concentrated juice per day for 10 days
|
concentrated beetroot juice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 10 days
|
Change in blood pressure between interventions
|
10 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oxygen cost of exercise
Time Frame: 10 days
|
Change in oxygen consumption during exercise
|
10 days
|
Serial Subtraction test
Time Frame: 10 days
|
change in performance of the Serial Subtraction test
|
10 days
|
Microbiome
Time Frame: 10 days
|
change in oral microbiome measured by sequencing bacterial 16S rRNA genes
|
10 days
|
Brain metabolism
Time Frame: 10 days
|
change in brain metabolites measured measured by 1H MRS
|
10 days
|
6 minute walk test
Time Frame: 10 days
|
change in performance of 6 minute walk test
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew M Jones, PhD, University of Exeter
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 12, 2014
Primary Completion (ACTUAL)
May 28, 2015
Study Completion (ACTUAL)
January 1, 2018
Study Registration Dates
First Submitted
January 31, 2018
First Submitted That Met QC Criteria
March 14, 2018
First Posted (ACTUAL)
March 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 14, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 121964
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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