Recruiting

Dietary Nitrate

Sponsor:

Marquette University

Code:

NCT05313490

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Beetroot Juice

Placebo Beetroot Juice

Study Details

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

Study ID

NCT05313490

Start date

May 1, 2022

Status verified date

Aug, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Beetroot Juice

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

placebo comparator: Placebo Beetroot Juice

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

Interventions

Beetroot Juice

7 days of 140 mL per day of beetroot juice

Placebo Beetroot Juice

7 days of 140 mL per day of placebo beetroot juice

Primary outcome measure

  • Change in fatigability of the knee extensor muscles with beetroot juice supplementation [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Timothy Fulton, PhD

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

Locations

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Lauren J Opielinski, MS

hunterlab@marquette.edu

More Information

Sponsor

Marquette University

Last update posted

Aug 24, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Marquette University on 2022-08-24.