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Impact of Oligonol to Cardiometabolic Risk and Muscular Health

Primary Purpose

Muscle Loss, Muscle Weakness, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Oligonol intake
Placebo
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Muscle Loss

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taipei Veteran General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oligonol intake group

Placebo group

Arm Description

This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.

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

Outcomes

Primary Outcome Measures

Changes from baseline muscle after 12 weeks
Change from baseline muscle via MRI after 12 weeks.
Changes from baseline fat content of leg after 12 weeks
Change from baseline fat content of leg via MRI after 12 weeks.
Changes form baseline chair-stand after 12 weeks
measured by the time of chair-stand after 12 weeks.
Changes form baseline muscle strength after 12 weeks
measured by hand grip distance after 12 weeks.
Change from baseline Nutrition intake after 12 weeks
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
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
Change from baseline endurance after 12 weeks
measured by 6-minute walk distance
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Change from baseline timed up and go test after 12 weeks
measured by timed up and go test (TUG)

Secondary Outcome Measures

Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
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
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine protein after 12 weeks

Full Information

First Posted
December 19, 2018
Last Updated
April 13, 2023
Sponsor
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT03788577
Brief Title
Impact of Oligonol to Cardiometabolic Risk and Muscular Health
Official Title
Impact of Oligonol to Cardiometabolic Risk and Muscular Health: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 4, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Loss, Muscle Weakness, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oligonol intake group
Arm Type
Experimental
Arm Description
This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Oligonol intake
Intervention Description
Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Changes from baseline muscle after 12 weeks
Description
Change from baseline muscle via MRI after 12 weeks.
Time Frame
baseline,12 weeks
Title
Changes from baseline fat content of leg after 12 weeks
Description
Change from baseline fat content of leg via MRI after 12 weeks.
Time Frame
baseline,12 weeks
Title
Changes form baseline chair-stand after 12 weeks
Description
measured by the time of chair-stand after 12 weeks.
Time Frame
baseline, 12 weeks
Title
Changes form baseline muscle strength after 12 weeks
Description
measured by hand grip distance after 12 weeks.
Time Frame
baseline, 12 weeks
Title
Change from baseline Nutrition intake after 12 weeks
Description
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Time Frame
baseline, 12 weeks
Title
Change from baseline depression after 12 weeks
Description
measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
Time Frame
baseline, 12 weeks
Title
Change from baseline endurance after 12 weeks
Description
measured by 6-minute walk distance
Time Frame
baseline, 12 weeks
Title
Change from baseline walking speed after 12 weeks
Description
measured by six-meter walking speed
Time Frame
baseline, 12 weeks
Title
Change from baseline timed up and go test after 12 weeks
Description
measured by timed up and go test (TUG)
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline numbers of Complete blood count after 12 weeks
Description
Change from baseline numbers of Complete blood count after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Albumin after 12 weeks
Description
Change from baseline concentration of Albumin after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
Description
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
Description
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of blood urea nitrogen after 12 weeks
Description
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Creatinin after 12 weeks
Description
Change from baseline concentration of Creatinin after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Fasting glucose after 12 weeks
Description
Change from baseline concentration of Fasting glucose after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Total Cholesterol after 12 weeks
Description
Change from baseline concentration of Total Cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Triglyceride after 12 weeks
Description
Change from baseline concentration of Triglyceride after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Description
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Description
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Description
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Leptin after 12 weeks
Description
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of urine protein after 12 weeks
Description
Change from baseline concentration of urine protein after 12 weeks
Time Frame
baseline,12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Kung Chen, MD.PhD.
Organizational Affiliation
Center for Healthy Longevity and Aging Sciences, National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veteran General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Oligonol to Cardiometabolic Risk and Muscular Health

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