SarcopeniaNCT05460351
Beetroot Juice Resistance Training Older Adults
A study testing BRJ+Nitrate in people with Sarcopenia and Old Age; Atrophy, run by Wake Forest University.
Trial summary
The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Old Age; Atrophy
- What is being tested?
- BRJ+Nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide own transportation to study testing visits and intervention
- Able to read and write in English
- Nondiabetic, i.e. fasting glucose < 126 mg/dl
- Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)
- Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.
Who cannot join
- Smoking or use of chewing tobacco
- Involved in another intervention research study
- Diabetic (type 1 or 2)
- Atrophic gastritis
- Hypo- or hyperthyroidism
- Gout or history of kidney stones
Show all 16Show fewer
- History of hypotension
- Premenopausal (women)
- Aversion to study-related testing procedures
- Allergy/sensitivity/aversion to beetroot beverages or protein supplement
- Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement
- Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases)
- Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism
- Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons
- Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program
- Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively.
About this study
Official title: Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement
The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.
- Conditions
- Sarcopenia, Old Age; Atrophy
- Being tested
- BRJ+Nitrate, Control
- Medical subject headings
- Sarcopenia, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRJ+NitrateDietary supplement
Participants in this group drank a 70 mL bottle of Beet It Sport drink with nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program
ControlDietary supplement
Participants in this group drank a 70 mL bottle of Beet It Sport drink without nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program
| Study group | Role | What they receive |
|---|---|---|
| BRJ+Nitrate | Experimental | This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 380 mg of nitrate plus a 15 dose of whey protein after each exercise session. Receives: Dietary Supplement: BRJ+Nitrate |
| Control | Placebo comparator | This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 0 mg of nitrate plus a 15 dose of whey protein after each exercise session. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body fat free mass
Mass of fat free tissue
Measured: Collected at baseline
Whole body fat mass
Mass of fat tissue
Measured: Collected at baseline
Thigh muscle
Volume of thigh muscle
Measured: Collected at baseline
Thigh intermuscular fat
Volume of fat in the thigh muscle
Measured: Collected at baseline
Thigh subcutaneous fat
Volume of subcutaneous fat in the thigh
Measured: Collected at baseline
Visceral fat
Volume of visceral fat
Measured: Collected at baseline
Muscle strength
Strength of quadriceps muscle at a speed of 60 degrees per second
Measured: Collected at baseline
400 meter walk
Time to walk 400 meters
Measured: Collected at baseline
Stair climb time
Time to ascend and descend 12 stairs
Measured: Collected at baseline
Peak oxygen consumption
Peak oxygen consumed at maximal exercise during graded exercise testing
Measured: Collected at baseline
Whole body fat free mass
mass of fat free tissue
Measured: Collected at 10-weeks
Whole body fat mass
Mass of fat tissue
Measured: Collected at 10-weeks
Thigh muscle
Volume of thigh muscle
Measured: Collected at 10-weeks
Thigh intermuscular fat
Volume of fat in the thigh muscle
Measured: Collected at 10-weeks
Thigh subcutaneous fat
Volume of subcutaneous fat in the thigh
Measured: Collected at 10-weeks
Visceral fat
Volume of visceral fat
Measured: Collected at 10-weeks
Muscle strength
Strength of quadriceps muscle at a speed of 60 degrees per second
Measured: Collected at 10-weeks
400 meter walk
Time to walk 400 meters
Measured: Collected at 10-weeks
Stair climb time
Time to ascend and descend 12 stairs
Measured: Collected at 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study startFeb 2014
- Primary completionDec 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Parallel groups
- Model description
- Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed. Both groups will undergo resistance exercise training and consume a protein supplement
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Miller, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460351
- Sponsor's protocol ID
- IRB00025941
- Status last verified
- Jul 2022
- First submitted
- 4 Jul 2022
- Last updated
- 15 Jul 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 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement
- ClinicalTrials.gov ID
- NCT05460351
- Acronym / sponsor ID
- IRB00025941
- Conditions
- Sarcopenia, Old Age; Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jul 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.
The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into one of two groups. The first group will consume daily beetroot juice containing 380 mg of nitrate and the second group will consume daily beetroot juice with nitrate removed. Both groups will undergo resistance exercise training and consume a protein supplement
| Arm | Type | Receives |
|---|---|---|
| BRJ+Nitrate | Experimental | Dietary Supplement: BRJ+NitrateThis arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 380 mg of nitrate plus a 15 dose of whey protein after each exercise session. |
| Control | Placebo comparator | Dietary Supplement: ControlThis arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 0 mg of nitrate plus a 15 dose of whey protein after each exercise session. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to provide own transportation to study testing visits and intervention
- Able to read and write in English
- Nondiabetic, i.e. fasting glucose < 126 mg/dl
- Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)
- Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.
Key exclusion criteria (16 listed)
- Smoking or use of chewing tobacco
- Involved in another intervention research study
- Diabetic (type 1 or 2)
- Atrophic gastritis
- Hypo- or hyperthyroidism
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 |
|---|---|---|
| BRJ+NitrateParticipants in this group drank a 70 mL bottle of Beet It Sport drink with nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program | Dietary supplement | BRJ+Nitrate |
| ControlParticipants in this group drank a 70 mL bottle of Beet It Sport drink without nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program | Dietary supplement | Control |
Primary outcome
Whole body fat free mass
Time frame: Collected at baseline
Mass of fat free tissue
Whole body fat mass
Time frame: Collected at baseline
Mass of fat tissue
Thigh muscle
Time frame: Collected at baseline
Volume of thigh muscle
Thigh intermuscular fat
Time frame: Collected at baseline
Volume of fat in the thigh muscle
Thigh subcutaneous fat
Time frame: Collected at baseline
Volume of subcutaneous fat in the thigh
Visceral fat
Time frame: Collected at baseline
Volume of visceral fat
Muscle strength
Time frame: Collected at baseline
Strength of quadriceps muscle at a speed of 60 degrees per second
400 meter walk
Time frame: Collected at baseline
Time to walk 400 meters
Stair climb time
Time frame: Collected at baseline
Time to ascend and descend 12 stairs
Peak oxygen consumption
Time frame: Collected at baseline
Peak oxygen consumed at maximal exercise during graded exercise testing
Whole body fat free mass
Time frame: Collected at 10-weeks
mass of fat free tissue
Whole body fat mass
Time frame: Collected at 10-weeks
Mass of fat tissue
Thigh muscle
Time frame: Collected at 10-weeks
Volume of thigh muscle
Thigh intermuscular fat
Time frame: Collected at 10-weeks
Volume of fat in the thigh muscle
Thigh subcutaneous fat
Time frame: Collected at 10-weeks
Volume of subcutaneous fat in the thigh
Visceral fat
Time frame: Collected at 10-weeks
Volume of visceral fat
Muscle strength
Time frame: Collected at 10-weeks
Strength of quadriceps muscle at a speed of 60 degrees per second
400 meter walk
Time frame: Collected at 10-weeks
Time to walk 400 meters
Stair climb time
Time frame: Collected at 10-weeks
Time to ascend and descend 12 stairs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing BRJ+Nitrate in people with Sarcopenia and Old Age; Atrophy, run by Wake Forest University.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body fat free mass (time frame: Collected at baseline). The study lists 19 primary outcomes in all. 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 15 Jul 2022.