Impact of Oligonol to Cardiometabolic Risk and Muscular Health

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Muscle Weakness; Muscle Loss
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Oligonol intake

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Taipei Veteran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline muscle after 12 weeks	Change from baseline muscle via MRI after 12 weeks.	baseline,12 weeks
Changes from baseline fat content of leg after 12 weeks	Change from baseline fat content of leg via MRI after 12 weeks.	baseline,12 weeks
Changes form baseline chair-stand after 12 weeks	measured by the time of chair-stand after 12 weeks.	baseline, 12 weeks
Changes form baseline muscle strength after 12 weeks	measured by hand grip distance after 12 weeks.	baseline, 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	baseline, 12 weeks
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	baseline, 12 weeks
Change from baseline endurance after 12 weeks	measured by 6-minute walk distance	baseline, 12 weeks
Change from baseline walking speed after 12 weeks	measured by six-meter walking speed	baseline, 12 weeks
Change from baseline timed up and go test after 12 weeks	measured by timed up and go test (TUG)	baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline numbers of Complete blood count after 12 weeks	Change from baseline numbers of Complete blood count after 12 weeks	baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks	Change from baseline concentration of Albumin after 12 weeks	baseline,12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.	Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.	baseline,12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.	Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.	baseline,12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks	Change from baseline concentration of blood urea nitrogen after 12 weeks	baseline,12 weeks
Change from baseline concentration of Creatinin after 12 weeks	Change from baseline concentration of Creatinin after 12 weeks	baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks	Change from baseline concentration of Fasting glucose after 12 weeks	baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks	Change from baseline concentration of Total Cholesterol after 12 weeks	baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks	Change from baseline concentration of Triglyceride after 12 weeks	baseline,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	baseline,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	baseline,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	baseline,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks	Change from baseline concentration of dehydroepiandrosterone after 12 weeks	baseline,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	baseline,12 weeks
Change from baseline concentration of Leptin after 12 weeks	Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks	baseline,12 weeks
Change from baseline concentration of urine protein after 12 weeks	Change from baseline concentration of urine protein after 12 weeks	baseline,12 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Investigators: Principal Investigator: Liang-Kung Chen, MD.PhD., Center for Healthy Longevity and Aging Sciences, National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (Actual): December 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2023
• Last Update Submitted That Met QC Criteria: April 13, 2023
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 2018-05-004B

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