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

NCT05313490 | Unknown

• 1 other identifier: HR-4040
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Change in fatigability of the knee extensor muscles with beetroot juice supplementation

  Fatigability will be quantified as the reduction in limb muscle power output during a 4-minute dynamic fatiguing exercise task using a dynamometer. Fatigability after 7 days of beetroot juice supplementation will be compared with fatigability after 7 days of placebo supplementation, with the outcome measure being the change (or difference) between these two supplementation conditions.

  Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)

Secondary Outcomes (2)

• Change in femoral artery blood flow with beetroot juice supplementation

  Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)

• Change in muscle efficiency with beetroot juice supplementation

  Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)

Other Outcomes (2)

• Change in plasma nitrate concentration with beetroot juice supplementation

  Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)

• Change in plasma nitrite concentration with beetroot juice supplementation

  Day 8 (after 7 days of placebo supplementation) and day 29 (after 14 days of a washout period with no supplementation plus 7 days of beetroot juice supplementation)

Study Arms (2)

Beetroot Juice

ACTIVE COMPARATOR

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

Dietary Supplement: Beetroot Juice

Placebo Beetroot Juice

PLACEBO COMPARATOR

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

Other: Placebo Beetroot Juice

Interventions

Beetroot Juice DIETARY_SUPPLEMENT

7 days of 140 mL per day of beetroot juice

Also known as: James White Drinks Beet It Sport 400

Beetroot Juice

Placebo Beetroot Juice OTHER

7 days of 140 mL per day of placebo beetroot juice

Placebo Beetroot Juice

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women ≥ 60 years old

You may not qualify if:

• body mass index ≥40 kg/m2;
• type 1 or type 2 diabetes or HbA1c \>6.5%
• uncontrolled hypertension;
• active cancer, cancer in remission, or having received treatment for any form of cancer in the previous five years;
• coronary artery disease;
• cardiovascular disease (e.g., PAD, PVD);
• abnormal and untreated thyroid function;
• chronic and/or regular nonsteroidal anti-inflammatory drugs (NSAID) consumption,
• tobacco use (includes smoking);
• 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).

Sponsors & Collaborators

• Marquette University: lead

Study Sites (1)

Marquette University

Milwaukee, Wisconsin, 53233, United States

RECRUITING

Central Study Contacts

Timothy Fulton, PhD

CONTACT

319-290-5529; timothy.fulton@marquette.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: April 6, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)