Impact of Oligonol to Cardiometabolic Risk and Muscular Health

Study Overview
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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.

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

Conditions
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Muscle Loss, Muscle Weakness, Quality of Life

Intervention / Treatment
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* Dietary Supplement: Oligonol intake
* Dietary Supplement: Placebo


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oligonol intake group<br>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<br>* Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.<br>|
| Placebo Comparator: Placebo group<br>This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks. | Dietary Supplement: Placebo<br>* Placebo<br>|

What is the study measuring?
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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 |