Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly

NCT ID: NCT03368872

Last Updated: 2017-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Sarcopenia

Keywords

Sarcopenia, muscle function, muscle endurance, fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo and exercise

Placebo intake for one month followed by 3-month exercise training with placebo intake.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo will be orally administered starting on Day 1 until Day 120.

Exercise training

Intervention Type: OTHER

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.

Astaxanthin and exercise

Astaxanthin formulation intake for one month followed by a 3-month exercise training program with astaxanthin formulation intake.

Group Type: EXPERIMENTAL

Astaxanthin formulation

Intervention Type: OTHER

Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120

Exercise training

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

Placebo

Placebo will be orally administered starting on Day 1 until Day 120.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

AstaMed MYO

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Astavita, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fred Hutchinson Cancer Research Center Prevention Center

Seattle, Washington, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

Ax sarcopenia study

Identifier Type: -

Identifier Source: org_study_id