NCT03473678

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

January 31, 2018

Last Update Submit

March 14, 2018

Conditions

Blood PressureCognitive ChangeFunctional CapacityBrain Metabolism

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Change in blood pressure between interventions

    10 days

Secondary Outcomes (5)

  • Oxygen cost of exercise

    10 days

  • Serial Subtraction test

    10 days

  • Microbiome

    10 days

  • Brain metabolism

    10 days

  • 6 minute walk test

    10 days

Study Arms (2)

Nitrate-rich beetroot juice

ACTIVE COMPARATOR

2 x 70mL concentrated juice per day for 10 days

Dietary Supplement: Nitrate-rich beetroot juice

Nitrate-depleted beetroot juice

PLACEBO COMPARATOR

2 x 70mL concentrated juice per day for 10 days

Dietary Supplement: Nitrate-depleted beetroot juice

Interventions

Nitrate-rich beetroot juiceDIETARY_SUPPLEMENT

concentrated beetroot juice

Nitrate-rich beetroot juice
Nitrate-depleted beetroot juiceDIETARY_SUPPLEMENT

concentrated beetroot juice

Nitrate-depleted beetroot juice

Eligibility Criteria

Age70 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age
  • male or female

You may not qualify if:

  • involved in regular structured exercise
  • receiving medication for:
  • pulmonary conditions
  • cardiovascular conditions
  • metabolic conditions
  • musculoskeletal conditions
  • ulcerative colitis
  • renal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Health Sciences, University of Exeter

Exeter, Devon, EX12LU, United Kingdom

Location

Study Officials

  • Andrew M Jones, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2018

First Posted

March 22, 2018

Study Start

February 12, 2014

Primary Completion

May 28, 2015

Study Completion

January 1, 2018

Last Updated

March 22, 2018

Record last verified: 2018-03

Locations

GB(1)