Clinical trial NCT03368872: Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia, muscle function, muscle endurance, fatigue
Lead sponsor: Astavita, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-11
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief 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 dysfunction/sarcopenia.


Eligibility criteria: Inclusion Criteria:

* Able to travel to and from the study facilities
* Informed consent obtained

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS)
timeFrame: Day 30 - Day 120
Secondary outcomes:
measure: Muscle energetics
timeFrame: Day 30-Day 120
measure: Hand grip strength
timeFrame: Day 30-Day120
measure: 6-minute walk test
timeFrame: Day 30-Day 120
measure: Safety Measures
timeFrame: Baseline-Day 30-Day 120
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center Prevention Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
References: