NCT02593305

Brief Summary

The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity, and blood pressure responsiveness to a variety of physiological stressors in older healthy adults. We will also examine the effect of dietary nitrate supplementation on measures of central artery stiffness and aortic blood pressure in older adults. Lastly, we will also recruit a group of young subjects in order to help characterize the age-related changes associated with the physiological outcome measures of the present study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2019

Completed
Last Updated

October 14, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

October 27, 2015

Results QC Date

October 12, 2018

Last Update Submit

September 24, 2019

Conditions

Keywords

nitrateblood flowblood pressurevascular functionhypoxia

Outcome Measures

Primary Outcomes (2)

  • Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults

    Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.

    Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.

  • Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.

    Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.

    Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.

Study Arms (3)

Beetroot crystals (nitrate), then placebo

EXPERIMENTAL

Participants will receive a nitrate rich beetroot powder (10g/day) for 4 weeks. After a washout period of 4 weeks, they will then receive the placebo (beetroot powder, no nitrate) for 4 weeks.

Dietary Supplement: Super BeetsDietary Supplement: Super Beets Placebo

Placebo, then beetroot crystals (nitrate)

EXPERIMENTAL

Participants will receive a beetroot powder placebo (no nitrate) for 4 weeks. After a 4 week washout period, they will receive the nitrate rich beetroot powder for 4 weeks.

Dietary Supplement: Super BeetsDietary Supplement: Super Beets Placebo

Young Comparison

NO INTERVENTION

Young control group, used for age-related comparisons. This group did not go through any intervention.

Interventions

Super BeetsDIETARY_SUPPLEMENT

Nitrate rich beetroot powder (10g/day) for 4 weeks

Also known as: Beetroot crystals
Beetroot crystals (nitrate), then placeboPlacebo, then beetroot crystals (nitrate)
Super Beets PlaceboDIETARY_SUPPLEMENT

Nitrate deficient beetroot powder (10g/day) for 4 weeks

Also known as: Beetroot crystals no nitrate
Beetroot crystals (nitrate), then placeboPlacebo, then beetroot crystals (nitrate)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy young adults 18-35 years of age (comparison group)
  • Healthy older adults 60-85 years of age (intervention group)

You may not qualify if:

  • Hypertension, hyperlipidemia, current smoker or smoker within the last year, heart disease, diabetes, Chronic obstructive pulmonary disease, asthma, sleep apnea, Raynaud's disease, body mass index (BMI) \> 30 kg/m2, allergy medication, clinical depression, autonomic disorders and other conditions or medications that might normally alter cardiovascular function, exercise tolerance, and/or blood pressure responses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

All subjects (young and older) completed the initial study visit. The young adults were used as a comparison group only and did not go through any intervention. The older adults underwent the intervention and completed a total of four study visits.

Results Point of Contact

Title
Dr. Darren P. Casey
Organization
University of Iowa

Study Officials

  • Darren Casey, PhD.

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 27, 2015

First Posted

November 2, 2015

Study Start

October 1, 2015

Primary Completion

April 28, 2017

Study Completion

April 28, 2017

Last Updated

October 14, 2019

Results First Posted

October 14, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations