Status:
COMPLETED
Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly
Lead Sponsor:
Astavita, Inc.
Conditions:
Sarcopenia
Eligibility:
All Genders
65-85 years
Phase:
NA
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 exercis...
Eligibility Criteria
Inclusion
- Able to travel to and from the study facilities
- Informed consent obtained
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2016
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03368872
Start Date
October 1 2015
End Date
August 1 2016
Last Update
December 11 2017
Active Locations (2)
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1
Fred Hutchinson Cancer Research Center Prevention Center
Seattle, Washington, United States, 98109
2
University of Washington Medical Center
Seattle, Washington, United States, 98195