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Impact of Oligonol to Cardiometabolic Risk and Muscular Health

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ClinicalTrials.gov Identifier: NCT03788577
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
National Yang Ming University

Brief Summary:
This project will mainly focus on Middle and old-aged adults, and examine whether Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will develop strategies for improving muscle loss , muscle strength decline, and the quality life of the elderly.

Condition or disease Intervention/treatment Phase
Muscle Loss Muscle Weakness Quality of Life Dietary Supplement: Oligonol intake Dietary Supplement: Placebo Not Applicable

Detailed Description:
Cardiovascular diseases are common among the elder. However, previous researches mainly focus on observational research or small scale clinical trial, and the subjects are mainly youth. Therefore, this project hope to understand whether Oligonol can reduce Cardiovascular and metabolic risks among senior adults. Consequently,improve muscle loss muscle strength decline, quality of old adults life. This project design may potentially develop new strategies for curing Sarcopenia as well.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Impact of Oligonol to Cardiometabolic Risk and Muscular Health: a Randomized Controlled Trial
Actual Study Start Date : December 4, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Arm Intervention/treatment
Experimental: Oligonol intake group
This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.
Dietary Supplement: Oligonol intake
Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.

Placebo Comparator: Placebo group
This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks.
Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Changes from baseline muscle after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline muscle via MRI after 12 weeks.

  2. Changes from baseline fat content of leg after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline fat content of leg via MRI after 12 weeks.

  3. Changes form baseline chair-stand after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by the time of chair-stand after 12 weeks.

  4. Changes form baseline muscle strength after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by hand grip distance after 12 weeks.

  5. Change from baseline Nutrition intake after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

  6. Change from baseline depression after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

  7. Change from baseline endurance after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by 6-minute walk distance

  8. Change from baseline walking speed after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by six-meter walking speed

  9. Change from baseline timed up and go test after 12 weeks [ Time Frame: baseline, 12 weeks ]
    measured by timed up and go test (TUG)


Secondary Outcome Measures :
  1. Change from baseline numbers of Complete blood count after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline numbers of Complete blood count after 12 weeks

  2. Change from baseline concentration of Albumin after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Albumin after 12 weeks

  3. Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks. [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.

  4. Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks. [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.

  5. Change from baseline concentration of blood urea nitrogen after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of blood urea nitrogen after 12 weeks

  6. Change from baseline concentration of Creatinin after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Creatinin after 12 weeks

  7. Change from baseline concentration of Fasting glucose after 12 weeks [ Time Frame: baseline,12 weeks ]

    Change from baseline concentration of Fasting glucose after 12 weeks

    [Time Frame: baseline,12 weeks]


  8. Change from baseline concentration of Total Cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Total Cholesterol after 12 weeks

  9. Change from baseline concentration of Triglyceride after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Triglyceride after 12 weeks

  10. Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks

  11. Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks

  12. Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks

  13. Change from baseline concentration of dehydroepiandrosterone after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of dehydroepiandrosterone after 12 weeks

  14. Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

  15. Change from baseline concentration of Leptin after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

  16. Change from baseline concentration of urine protein after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of urine protein after 12 weeks



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • People who aged more than 50 years
  • Patients with following characteristics:
  • feeling loss in activity.
  • detecting decline in self's walking speed.
  • feeling tired of doing everything.
  • having fallen down last year.
  • People can accept undergoing MRI
  • People willing to follow the program and cooperate with us for following tracking.
  • People who are neither vegan nor vegetarian

Exclusion Criteria:

  • Walking speed less than 0.3m/s
  • People with any disease affecting their limbs, including:
  • having fracture on limbs in the past 6 months.
  • having severe arthritis in the past 6 months
  • any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
  • People with intermittent limp caused by peripheral artery diseases
  • People with weak control of mental disorder
  • People with weak control of Cardiopulmonary disease
  • People with weak control of Malignant tumor
  • People with weak control of kidney diseases (GFR < 30 mL/min/1.73 m2 for at least 3 months)
  • People with visual impairment and hearing disorder who cannot complete the program.
  • People who are unable to undertake MRI
  • Any other condition that PI recognized as not suitable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788577


Contacts
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Contact: Liang-Kung Chen, MD.PhD. 886-2-28239014 lkchen2@vghtpe.gov.tw

Locations
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Taiwan
Taipei Veteran General Hospital Recruiting
Taipei, Taiwan, 112
Contact: Liang-Kung Chen, MD.PhD.    886-2-28239014    lkchen2@vghtpe.gov.tw   
Sponsors and Collaborators
National Yang Ming University
Investigators
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Principal Investigator: Liang-Kung Chen, MD.PhD. Aging and Health Research Center, National Yang Ming University

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Responsible Party: National Yang Ming University
ClinicalTrials.gov Identifier: NCT03788577     History of Changes
Other Study ID Numbers: 2018-05-004B
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Muscle Weakness
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms