Clinical Trial of Astaxanthin Formulation With Exercise in Sarcopenia Elderly

December 6, 2017 updated by: Astavita, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center Prevention Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Astaxanthin and exercise
Astaxanthin formulation intake for one month followed by a 3-month exercise training program with astaxanthin formulation intake.
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
Other Names:
  • AstaMed MYO
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.
Placebo Comparator: Placebo and exercise
Placebo intake for one month followed by 3-month exercise training with placebo intake.
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.
Other: Placebo
Placebo will be orally administered starting on Day 1 until Day 120.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 30 - Day 120

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle energetics
Time Frame: Day 30-Day 120
Muscle energetics and size measured by 31p MRS: Baseline
Day 30-Day 120
Hand grip strength
Time Frame: Day 30-Day120
Hand grip strength
Day 30-Day120
6-minute walk test
Time Frame: Day 30-Day 120
6-minute walk test
Day 30-Day 120
Safety Measures
Time Frame: Baseline-Day 30-Day 120
Safety as assessed by measures such as adverse events
Baseline-Day 30-Day 120

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astavita, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ax sarcopenia study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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