Dietary Nitrate and Healthy Older Adults

• Sponsor: University of Exeter (Other)
• Overall Status: Completed
• CT.gov ID: NCT03473678
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 46.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Feb 12, 2014
• Actual Primary Completion Date: May 28, 2015
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Blood pressure [10 days]

   Change in blood pressure between interventions

Secondary Outcome Measures

1. Oxygen cost of exercise [10 days]

   Change in oxygen consumption during exercise

2. Serial Subtraction test [10 days]

   change in performance of the Serial Subtraction test

3. Microbiome [10 days]

   change in oral microbiome measured by sequencing bacterial 16S rRNA genes

4. Brain metabolism [10 days]

   change in brain metabolites measured measured by 1H MRS

5. 6 minute walk test [10 days]

   change in performance of 6 minute walk test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sport and Health Sciences, University of Exeter	Exeter	Devon	United Kingdom	EX12LU

Sponsors and Collaborators

• University of Exeter

Investigators

• Principal Investigator: Andrew M Jones, PhD, University of Exeter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Exeter
• ClinicalTrials.gov Identifier: NCT03473678
• Other Study ID Numbers: 121964
• First Posted: Mar 22, 2018
• Last Update Posted: Mar 22, 2018
• Last Verified: Mar 1, 2018

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

Study Results

No Results Posted as of Mar 22, 2018