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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313490
• Other study ID #: HR-4040
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2022
• Source: Marquette University
• Contact: Timothy Fulton, PhD
• Phone: 319-290-5529
• Email: timothy.fulton[@]marquette.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• Beetroot Juice
7 days of 140 mL per day of beetroot juice

Other:
• Placebo Beetroot Juice
7 days of 140 mL per day of placebo beetroot juice

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma nitrate concentration with beetroot juice supplementation	Plasma nitrate concentration will be quantified using a nitrate colorimetric assay. Plasma nitrate concentration after 7 days of beetroot juice supplementation will be compared with plasma nitrate concentration 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)
Other	Change in plasma nitrite concentration with beetroot juice supplementation	Plasma nitrite concentration will be quantified using a nitrite colorimetric assay. Plasma nitrite concentration after 7 days of beetroot juice supplementation will be compared with plasma nitrite concentration 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)
Primary	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	Change in femoral artery blood flow with beetroot juice supplementation	Femoral artery blood flow will be quantified as the change in femoral artery blood flow during a 4-minute dynamic fatiguing exercise task using a ultrasonography. Femoral artery blood flow after 7 days of beetroot juice supplementation will be compared with Femoral artery blood flow 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	Change in muscle efficiency with beetroot juice supplementation	Muscle efficiency will be quantified as the ATP cost of contraction using phosphorus magnetic resonance spectroscopy (P-MRS). Muscle efficiency after 7 days of beetroot juice supplementation will be compared with muscle efficiency 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)