Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation

NCT ID: NCT05313490

Last Updated: 2022-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-12-31

Brief Summary

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Vascular and skeletal muscle function decline with age and are associated with decreased nitric oxide (NO) bioavailability. Dietary nitrate supplementation in the form of beet root juice increases NO bioavailability and improves exercise tolerance in younger adults, yet its effects on fatigability in older adults are largely unknown. The proposed research will investigate the impact of increased NO bioavailability on vascular function, skeletal muscle bioenergetics, and fatigability in older (≥65 yrs) men and women.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Beetroot Juice

The subject will ingest 140mL of a nitrate-rich beetroot juice each day for 7 consecutive days.

Group Type ACTIVE_COMPARATOR

Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

7 days of 140 mL per day of beetroot juice

Placebo Beetroot Juice

The subject will ingest 140mL of a placebo (nitrate-depleted) beetroot juice each day for 7 consecutive days.

Group Type PLACEBO_COMPARATOR

Placebo Beetroot Juice

Intervention Type OTHER

7 days of 140 mL per day of placebo beetroot juice

Interventions

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Beetroot Juice

7 days of 140 mL per day of beetroot juice

Intervention Type DIETARY_SUPPLEMENT

Placebo Beetroot Juice

7 days of 140 mL per day of placebo beetroot juice

Intervention Type OTHER

Other Intervention Names

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James White Drinks Beet It Sport 400

Eligibility Criteria

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Inclusion Criteria

* Healthy men and women ≥ 60 years old

Exclusion Criteria

1. body mass index ≥40 kg/m2;
2. type 1 or type 2 diabetes or HbA1c \>6.5%
3. uncontrolled hypertension;
4. active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years;
5. coronary artery disease;
6. cardiovascular disease (e.g., PAD, PVD);
7. abnormal and untreated thyroid function;
8. chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption,
9. tobacco use (includes smoking);
10. any condition that presents a limitation to exercise (e.g., severe arthritis, COPD, neuromuscular disorder, moderate or severe cognitive impairment, Alzheimer's Disease, severe untreated sleep apnea).
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marquette University

OTHER

Sponsor Role lead

Responsible Party

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Timothy Fulton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Marquette University

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timothy Fulton, PhD

Role: CONTACT

319-290-5529

Facility Contacts

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Lauren J Opielinski, MS

Role: primary

Other Identifiers

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HR-4040

Identifier Type: -

Identifier Source: org_study_id

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