Skip to main content
OpenTrials
Completed

NCT Number: NCT03788577

Impact of Oligonol to Cardiometabolic Risk and Muscular Health

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Muscle Loss Atrophy Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veteran General Hospital

Taipei, 112, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Oligonol intake

Dietary Supplement

Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.

Placebo

Dietary Supplement

Placebo

Primary outcomes

  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 outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Impact of Oligonol to Cardiometabolic Risk and Muscular Health: a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 27, 2018
Registry last updated
Apr 14, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.