Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03368872
• Other study ID #: Ax sarcopenia study
• Status: Completed
• Phase: N/A
• First received: December 6, 2017
• Last updated: December 6, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: Astavita, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 dysfunction/sarcopenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Other:
• Astaxanthin formulation
Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120
• Placebo
Placebo will be orally administered starting on Day 1 until Day 120.
• Exercise training
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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center Prevention Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Astavita, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 30 - Day 120
Secondary	Muscle energetics	Muscle energetics and size measured by 31p MRS: Baseline	Day 30-Day 120
Secondary	Hand grip strength	Hand grip strength	Day 30-Day120
Secondary	6-minute walk test	6-minute walk test	Day 30-Day 120
Secondary	Safety Measures	Safety as assessed by measures such as adverse events	Baseline-Day 30-Day 120