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Dietary Nitrate and Healthy Older Adults

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ClinicalTrials.gov Identifier: NCT03473678
Recruitment Status : Completed
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
University of Exeter

Brief 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

Condition or disease Intervention/treatment Phase
Blood Pressure Cognitive Change Functional Capacity Brain Metabolism Dietary Supplement: Nitrate-rich beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
Actual Study Start Date : February 12, 2014
Actual Primary Completion Date : May 28, 2015
Actual Study Completion Date : January 2018

Arm Intervention/treatment
Active Comparator: Nitrate-rich beetroot juice
2 x 70mL concentrated juice per day for 10 days
Dietary Supplement: Nitrate-rich beetroot juice
concentrated beetroot juice

Placebo Comparator: Nitrate-depleted beetroot juice
2 x 70mL concentrated juice per day for 10 days
Dietary Supplement: Nitrate-depleted beetroot juice
concentrated beetroot juice




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 10 days ]
    Change in blood pressure between interventions


Secondary Outcome Measures :
  1. Oxygen cost of exercise [ Time Frame: 10 days ]
    Change in oxygen consumption during exercise

  2. Serial Subtraction test [ Time Frame: 10 days ]
    change in performance of the Serial Subtraction test

  3. Microbiome [ Time Frame: 10 days ]
    change in oral microbiome measured by sequencing bacterial 16S rRNA genes

  4. Brain metabolism [ Time Frame: 10 days ]
    change in brain metabolites measured measured by 1H MRS

  5. 6 minute walk test [ Time Frame: 10 days ]
    change in performance of 6 minute walk test



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Ages Eligible for Study:   70 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473678


Locations
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United Kingdom
Sport and Health Sciences, University of Exeter
Exeter, Devon, United Kingdom, EX12LU
Sponsors and Collaborators
University of Exeter
Investigators
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Principal Investigator: Andrew M Jones, PhD University of Exeter

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Responsible Party: University of Exeter
ClinicalTrials.gov Identifier: NCT03473678     History of Changes
Other Study ID Numbers: 121964
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No