Clinical trial NCT03788577: 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
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Muscle Weakness
Quality of Life
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Changes from baseline muscle after 12 weeks
timeFrame: baseline,12 weeks
measure: Changes from baseline fat content of leg after 12 weeks
timeFrame: baseline,12 weeks
measure: Changes form baseline chair-stand after 12 weeks
timeFrame: baseline, 12 weeks
measure: Changes form baseline muscle strength after 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline Nutrition intake after 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline depression after 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline endurance after 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline walking speed after 12 weeks
timeFrame: baseline, 12 weeks
measure: Change from baseline timed up and go test after 12 weeks
timeFrame: baseline, 12 weeks
Secondary outcomes:
measure: Change from baseline numbers of Complete blood count after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Albumin after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of blood urea nitrogen after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Creatinin after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Fasting glucose after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Total Cholesterol after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Triglyceride after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of dehydroepiandrosterone after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of Leptin after 12 weeks
timeFrame: baseline,12 weeks
measure: Change from baseline concentration of urine protein after 12 weeks
timeFrame: baseline,12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Center for Healthy Longevity and Aging Sciences, National Yang Ming University
name: Liang-Kung Chen, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References: