Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 65 - 85 |
Updated: | 12/13/2017 |
Start Date: | October 2015 |
End Date: | August 2016 |
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.
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.
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
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