Impact of Oligonol to Cardiometabolic Risk and Muscular Health

NCT ID: NCT03788577

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2020-04-01

Brief Summary

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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

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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.

Conditions

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Muscle Loss Muscle Weakness Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oligonol intake group

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

Group Type EXPERIMENTAL

Oligonol intake

Intervention Type DIETARY_SUPPLEMENT

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Oligonol intake

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liang-Kung Chen, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Center for Healthy Longevity and Aging Sciences, National Yang Ming University

Locations

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Taipei Veteran General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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2018-05-004B

Identifier Type: -

Identifier Source: org_study_id

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