AgingNCT05313490
Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation
A study testing Beetroot Juice in people with Aging, run by Marquette University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Beetroot Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women ≥ 60 years old
Who cannot join
- 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);
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marquette University
Milwaukee, Wisconsin, 53233
Lauren J Opielinski, MS, hunterlab@marquette.edu
About this study
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
- Being tested
- Beetroot Juice, Placebo Beetroot Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot JuiceDietary supplement
Also called James White Drinks Beet It Sport 400
7 days of 140 mL per day of beetroot juice
Placebo Beetroot JuiceOther
7 days of 140 mL per day of placebo beetroot juice
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Juice | Active comparator | The subject will ingest 140mL of a nitrate-rich beetroot juice each day for 7 consecutive days. Receives: 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. Receives: Other: Placebo Beetroot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Fulton, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313490
- Sponsor's protocol ID
- HR-4040
- Status last verified
- Aug 2022
- First submitted
- 14 Feb 2022
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Fatiguability in Older Adults: The Protective Effects of Dietary Nitrate Supplementation
- ClinicalTrials.gov ID
- NCT05313490
- Acronym / sponsor ID
- HR-4040
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot Juice | Active comparator | Dietary Supplement: Beetroot JuiceThe subject will ingest 140mL of a nitrate-rich beetroot juice each day for 7 consecutive days. |
| Placebo Beetroot Juice | Placebo comparator | Other: Placebo Beetroot JuiceThe subject will ingest 140mL of a placebo (nitrate-depleted) beetroot juice each day for 7 consecutive days. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy men and women ≥ 60 years old
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot JuiceAlso: James White Drinks Beet It Sport 4007 days of 140 mL per day of beetroot juice | Dietary supplement | Beetroot Juice |
| Placebo Beetroot Juice7 days of 140 mL per day of placebo beetroot juice | Other | Placebo Beetroot Juice |
Primary outcome
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)
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.
2 secondary outcomes
Change in femoral artery blood flow 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)
Change in muscle efficiency 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot Juice in people with Aging, run by Marquette University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timothy Fulton, PhD (319-290-5529, timothy.fulton@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.