Clinical trial NCT05313490: Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation
Official title: Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in fatigability of the knee extensor muscles with beetroot juice supplementation
timeFrame: 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:
measure: Change in femoral artery blood flow with beetroot juice supplementation
timeFrame: 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)
measure: Change in muscle efficiency with beetroot juice supplementation
timeFrame: 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:
measure: Change in plasma nitrate concentration with beetroot juice supplementation
timeFrame: 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)
measure: Change in plasma nitrite concentration with beetroot juice supplementation
timeFrame: 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)
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: