Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly

NCT03368872 | Completed

• 1 other identifier: Ax sarcopenia study
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Muscle energetics

  Day 30-Day 120

• Hand grip strength

  Day 30-Day120

• 6-minute walk test

  Day 30-Day 120

• Safety Measures

  Baseline-Day 30-Day 120

Study Arms (2)

Astaxanthin and exercise

EXPERIMENTAL

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

Other: Astaxanthin formulation; Other: Exercise training

Placebo and exercise

PLACEBO COMPARATOR

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

Other: Placebo; Other: Exercise training

Interventions

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

Also known as: AstaMed MYO

Astaxanthin and exercise

Placebo OTHER

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

Placebo and exercise

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.

Astaxanthin and exercise; Placebo and exercise

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Able to travel to and from the study facilities
• Informed consent obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astavita, Inc.: lead

Study Sites (2)

Fred Hutchinson Cancer Research Center Prevention Center

Seattle, Washington, 98109, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Sarcopenia; Fatigue

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 11, 2017
• Study Start: October 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)