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CompletedNCT03788577Updated Apr 14, 2023

Impact of Oligonol to Cardiometabolic Risk and Muscular Health

An interventional study of Oligonol intake and Placebo in Muscle Loss, Muscle Weakness and Quality of Life, sponsored by National Yang Ming Chiao Tung University. Completed at 1 site in Taiwan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-04-14.

Sponsored by National Yang Ming Chiao Tung University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Muscle Loss
  • Muscle Weakness
  • Quality of Life
03

In context

Muscular Atrophy

503 studies on the registry are indexed under Muscular Atrophy; 94 are open to participants now.

This study's enrollment of 120 is above the median of 34 across 342 interventional studies indexed under Muscular Atrophy.

Browse Muscular Atrophy studies →

Lead sponsor

National Yang Ming Chiao Tung University is the lead sponsor of 204 studies on the registry; 58 are open to participants now.

Browse National Yang Ming Chiao Tung University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementOligonol intake

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

  • Dietary supplementPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Changes from baseline muscle after 12 weeks

    Change from baseline muscle via MRI after 12 weeks.

    Time frame: baseline,12 weeks

  2. Changes from baseline fat content of leg after 12 weeks

    Change from baseline fat content of leg via MRI after 12 weeks.

    Time frame: baseline,12 weeks

  3. Changes form baseline chair-stand after 12 weeks

    measured by the time of chair-stand after 12 weeks.

    Time frame: baseline, 12 weeks

  4. Changes form baseline muscle strength after 12 weeks

    measured by hand grip distance after 12 weeks.

    Time frame: baseline, 12 weeks

  5. Change from baseline Nutrition intake after 12 weeks

    measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

    Time frame: baseline, 12 weeks

  6. Change from baseline depression after 12 weeks

    measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

    Time frame: baseline, 12 weeks

  7. Change from baseline endurance after 12 weeks

    measured by 6-minute walk distance

    Time frame: baseline, 12 weeks

  8. Change from baseline walking speed after 12 weeks

    measured by six-meter walking speed

    Time frame: baseline, 12 weeks

  9. Change from baseline timed up and go test after 12 weeks

    measured by timed up and go test (TUG)

    Time frame: baseline, 12 weeks

Secondary outcomes

  1. Change from baseline numbers of Complete blood count after 12 weeks

    Change from baseline numbers of Complete blood count after 12 weeks

    Time frame: baseline,12 weeks

  2. Change from baseline concentration of Albumin after 12 weeks

    Change from baseline concentration of Albumin after 12 weeks

    Time frame: baseline,12 weeks

  3. Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.

    Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.

    Time frame: baseline,12 weeks

  4. Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.

    Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.

    Time frame: baseline,12 weeks

  5. Change from baseline concentration of blood urea nitrogen after 12 weeks

    Change from baseline concentration of blood urea nitrogen after 12 weeks

    Time frame: baseline,12 weeks

  6. Change from baseline concentration of Creatinin after 12 weeks

    Change from baseline concentration of Creatinin after 12 weeks

    Time frame: baseline,12 weeks

  7. Change from baseline concentration of Fasting glucose after 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

    Change from baseline concentration of Total Cholesterol after 12 weeks

    Time frame: baseline,12 weeks

  9. Change from baseline concentration of Triglyceride after 12 weeks

    Change from baseline concentration of Triglyceride after 12 weeks

    Time frame: baseline,12 weeks

  10. Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks

    Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks

    Time frame: baseline,12 weeks

  11. Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks

    Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks

    Time frame: baseline,12 weeks

  12. Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks

    Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks

    Time frame: baseline,12 weeks

  13. Change from baseline concentration of dehydroepiandrosterone after 12 weeks

    Change from baseline concentration of dehydroepiandrosterone after 12 weeks

    Time frame: baseline,12 weeks

  14. Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

    Time frame: baseline,12 weeks

  15. Change from baseline concentration of Leptin after 12 weeks

    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

    Time frame: baseline,12 weeks

  16. Change from baseline concentration of urine protein after 12 weeks

    Change from baseline concentration of urine protein after 12 weeks

    Time frame: baseline,12 weeks

07

Study locations

1 site
  • Taipei Veteran General Hospital
    Taipei, 112, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03788577
Lead sponsor
National Yang Ming Chiao Tung University
Responsible party
Sponsor
First posted
Dec 27, 2018
Start date
Dec 4, 2018
Primary completion
Apr 1, 2020
Completion
Apr 1, 2020
Last update
Apr 14, 2023

Study contacts

Liang-Kung Chen, MD.PhD.
principal investigator · Center for Healthy Longevity and Aging Sciences, National Yang Ming University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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