SarcopeniaNCT03368872
Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly
A study testing Astaxanthin formulation and Exercise training in people with Sarcopenia, run by Astavita, Inc. at 2 sites in United States.
Trial summary
The primary objective of this trial is to evaluate the effect of oral administration of an Astaxanthin formulation compared to placebo after one month alone and after an additional 3 months of exercise training on mitochondrial and skeletal muscle function in elderly subjects with evidence of mitochondrial… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Astaxanthin formulation and Exercise training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to Aug 2016
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to travel to and from the study facilities
- Informed consent obtained
Who cannot join
- Have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the trial or may influence either the results of the trial or the subject's ability to participate in the trial
- Hospitalization within 3 months for major atherosclerotic events (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery and stroke) and for any hospitalization within 2 months.
- Have any metal implant in the right upper limb, including metal stents, titanium pins/markers, etc.
- Have an implanted cardiac pacemaker or other implanted cardiac device
- Chronic, uncontrolled hypertension as judged by the Investigator (ie, Baseline SBP >150 mm Hg, DBP >90 mm Hg) or a SBP > 150 mm Hg or DBP > 95 mm Hg at the time of screening or baseline. If the initial BP reading is above these values, the reading may be repeated one time within 20 minutes of the initial reading.
- Body mass index <18 or >32 kg/m2
Show all 17Show fewer
- Creatinine clearance calculated by the Cr/G method calculated to be <45 mL/min
- Additional laboratory abnormalities determined as clinically significant by the Investigator Clinically significant abnormalities on physical examination (as judged by the Investigator)
- History or evidence of renal, hepatic, pulmonary (including chronic asthma), endocrine (eg, diabetes, hypo- and hyperthyroidism, adrenal insufficiency), central nervous or neurologic disorders (MS, epilepsy, history of seisures), or gastrointestinal (cirrhosis or viral hepatitis) system dysfunction
- History of seizures or epilepsy
- History of serious mental illness as judged by the Investigator
- Oral temperature >37.5°C at the time of the physical
- Suspicion, or recent history, of alcohol or substance abuse or tobacco use, including positive results from the laboratory screening panels conducted at screening
- Donated blood or blood products within the past 30 days
- Subjects who in the opinion of the Investigator have a clinically significant abnormal 12-lead ECG during the screening period. Presence of atrial fibrillation, varying degrees of AV block, existence of a left bundle branch block, or evidence of previous myocardial infarction.
- Subjects who are either unwilling to agree to refrain from using or found to be using supplementary antioxidant vitamins (eg, Coenzyme Q10) from 7 days prior to dosing and throughout the confinement period
- Are currently enrolled in a clinical trial involving an investigational product or non approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Have participated, within the last 30 days from a clinical trial involving an investigational product. If the previous investigational product has a long half life, 3 months or 5 half-lives (whichever is longer) should have passed
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center Prevention Center
Seattle, Washington, 98109
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Impact of a Daily Dose of an Astaxanthin Formulation Alone and With Exercise Training on Skeletal Muscle Function in the Elderly
The primary objective of this trial is to evaluate the effect of oral administration of an Astaxanthin formulation compared to placebo after one month alone and after an additional 3 months of exercise training on mitochondrial and skeletal muscle function in elderly subjects with evidence of mitochondrial dysfunction/sarcopenia.
- Conditions
- Sarcopenia
- Being tested
- Astaxanthin formulation, Placebo, Exercise training
- Keywords
- Sarcopenia, muscle function, muscle endurance, fatigue
- Medical subject headings
- Sarcopenia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin formulationOther
Also called AstaMed MYO
Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120
PlaceboOther
Placebo will be orally administered starting on Day 1 until Day 120.
Exercise trainingOther
The subjects will undergo interval treadmill incline protocol (target 85% HR max, 3 times a week for 40 to 60 minutes) starting on Day 31 until Day 120.
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin and exercise | Experimental | Astaxanthin formulation intake for one month followed by a 3-month exercise training program with astaxanthin formulation intake. Receives: Other: Astaxanthin formulation; Other: Exercise training |
| Placebo and exercise | Placebo comparator | Placebo intake for one month followed by 3-month exercise training with placebo intake. Receives: Other: Placebo; Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS)
Skeletal muscle strength and performance will be evaluated by changes from baseline in muscle work rate calculated from the results of the leg muscle fatigue protocol testing: Baseline-Day 30-Day 120.
Measured: Day 30 - Day 120
Secondary outcomes (4)
Muscle energetics
Muscle energetics and size measured by 31p MRS: Baseline
Measured: Day 30-Day 120
Hand grip strength
Hand grip strength
Measured: Day 30-Day120
6-minute walk test
6-minute walk test
Measured: Day 30-Day 120
Safety Measures
Safety as assessed by measures such as adverse events
Measured: Baseline-Day 30-Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astavita, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368872
- Sponsor's protocol ID
- Ax sarcopenia study
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 11 Dec 2017
- 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 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol for a Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Impact of a Daily Dose of an Astaxanthin Formulation Alone and With Exercise Training on Skeletal Muscle Function in the Elderly
- ClinicalTrials.gov ID
- NCT03368872
- Acronym / sponsor ID
- Ax sarcopenia study
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, muscle function, muscle endurance, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Astavita, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 11 Dec 2017 (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 primary objective of this trial is to evaluate the effect of oral administration of an Astaxanthin formulation compared to placebo after one month alone and after an additional 3 months of exercise training on mitochondrial and skeletal muscle function in elderly subjects with evidence of mitochondrial dysfunction/sarcopenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin and exercise | Experimental | Other: Astaxanthin formulation, Other: Exercise trainingAstaxanthin formulation intake for one month followed by a 3-month exercise training program with astaxanthin formulation intake. |
| Placebo and exercise | Placebo comparator | Other: Placebo, Other: Exercise trainingPlacebo intake for one month followed by 3-month exercise training with placebo intake. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to travel to and from the study facilities
- Informed consent obtained
Key exclusion criteria (17 listed)
- Have significant disease(s) or condition(s) which, in the opinion of the investigator, may put the subject at risk because of their participation in the trial or may influence either the results of the trial or the subject's ability to participate in the trial
- Hospitalization within 3 months for major atherosclerotic events (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery and stroke) and for any hospitalization within 2 months.
- Have any metal implant in the right upper limb, including metal stents, titanium pins/markers, etc.
- Have an implanted cardiac pacemaker or other implanted cardiac device
- Chronic, uncontrolled hypertension as judged by the Investigator (ie, Baseline SBP >150 mm Hg, DBP >90 mm Hg) or a SBP > 150 mm Hg or DBP > 95 mm Hg at the time of screening or baseline. If the initial BP reading is above these values, the reading may be repeated one time within 20 minutes of the initial reading.
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 |
|---|---|---|
| Astaxanthin formulationAlso: AstaMed MYOAstaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120 | Other | Astaxanthin and exercise |
| PlaceboPlacebo will be orally administered starting on Day 1 until Day 120. | Other | Placebo and exercise |
| Exercise trainingThe subjects will undergo interval treadmill incline protocol (target 85% HR max, 3 times a week for 40 to 60 minutes) starting on Day 31 until Day 120. | Other | Astaxanthin and exercise, Placebo and exercise |
Primary outcome
Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS)
Time frame: Day 30 - Day 120
Skeletal muscle strength and performance will be evaluated by changes from baseline in muscle work rate calculated from the results of the leg muscle fatigue protocol testing: Baseline-Day 30-Day 120.
4 secondary outcomes
Muscle energetics
Time frame: Day 30-Day 120
Hand grip strength
Time frame: Day 30-Day120
6-minute walk test
Time frame: Day 30-Day 120
Safety Measures
Time frame: Baseline-Day 30-Day 120
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 11 Dec 2017.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin formulation and Exercise training in people with Sarcopenia, run by Astavita, Inc. at 2 sites 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 2 inclusion and 17 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS) (time frame: Day 30 - Day 120). 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 11 Dec 2017.