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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

Tracking Information
First Submitted Date  ICMJE January 31, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date March 22, 2018
Actual Study Start Date  ICMJE February 12, 2014
Actual Primary Completion Date May 28, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Blood pressure [ Time Frame: 10 days ]
Change in blood pressure between interventions
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • Oxygen cost of exercise [ Time Frame: 10 days ]
    Change in oxygen consumption during exercise
  • Serial Subtraction test [ Time Frame: 10 days ]
    change in performance of the Serial Subtraction test
  • Microbiome [ Time Frame: 10 days ]
    change in oral microbiome measured by sequencing bacterial 16S rRNA genes
  • Brain metabolism [ Time Frame: 10 days ]
    change in brain metabolites measured measured by 1H MRS
  • 6 minute walk test [ Time Frame: 10 days ]
    change in performance of 6 minute walk test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dietary Nitrate and Healthy Older Adults
Official Title  ICMJE Influence of Dietary Nitrate Supplementation on Blood Pressure, Walking Economy, Functional Physical Capacity and Cognitive Function in Healthy Older Adults
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Blood Pressure
  • Cognitive Change
  • Functional Capacity
  • Brain Metabolism
Intervention  ICMJE
  • Dietary Supplement: Nitrate-rich beetroot juice
    concentrated beetroot juice
  • Dietary Supplement: Nitrate-depleted beetroot juice
    concentrated beetroot juice
Study Arms  ICMJE
  • Active Comparator: Nitrate-rich beetroot juice
    2 x 70mL concentrated juice per day for 10 days
    Intervention: Dietary Supplement: Nitrate-rich beetroot juice
  • Placebo Comparator: Nitrate-depleted beetroot juice
    2 x 70mL concentrated juice per day for 10 days
    Intervention: Dietary Supplement: Nitrate-depleted beetroot juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date May 28, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years to 80 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03473678
Other Study ID Numbers  ICMJE 121964
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Exeter
Study Sponsor  ICMJE University of Exeter
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew M Jones, PhD University of Exeter
PRS Account University of Exeter
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP