Dietary Nitrate and Healthy Older Adults | NCT03473678

Studies
Dietary Nitrate and Healthy Older Adults

NCT03473678

Sponsor

University of Exeter

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Blood Pressure
Cognitive Change
Functional Capacity
Brain Metabolism

Interventions

Nitrate-rich beetroot juice
Nitrate-depleted beetroot juice

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2014Actual

Primary Completion Date

May 28, 2015Actual

Completion Date

Jan 2018Actual

First Submitted Date

Jan 31, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2018

Last Update Posted Date

Mar 22, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nitrate-rich beetroot juice	Dietary Supplement	concentrated beetroot juice	Nitrate-rich beetroot juice

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure	Change in blood pressure between interventions	10 days

Secondary Outcomes

Measure	Description	Time Frame
Oxygen cost of exercise	Change in oxygen consumption during exercise	10 days
Serial Subtraction test	change in performance of the Serial Subtraction test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

80 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew M Jones, PhD	University of Exeter	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sport and Health Sciences, University of Exeter		Exeter	Devon	EX12LU	United Kingdom