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Completed

NCT Number: NCT03368872

Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia 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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center Prevention Center, Seattle, Washington, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Astaxanthin formulation

Other

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

Other names: AstaMed MYO

Placebo

Other

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

Exercise training

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.

Primary outcomes

  1. Skeletal muscle strength and performance measured by 31P-magnetic resonance spectroscopy (31p MRS)

    Time frame: Day 30 - Day 120

    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.

Secondary outcomes

  1. Muscle energetics

    Time frame: Day 30-Day 120

    Muscle energetics and size measured by 31p MRS: Baseline

  2. Hand grip strength

    Time frame: Day 30-Day120

    Hand grip strength

  3. 6-minute walk test

    Time frame: Day 30-Day 120

    6-minute walk test

  4. Safety Measures

    Time frame: Baseline-Day 30-Day 120

    Safety as assessed by measures such as adverse events

Sponsors and collaborators

Lead sponsor

Astavita, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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