Muscle LossNCT03788577
Impact of Oligonol to Cardiometabolic Risk and Muscular Health
A study testing Oligonol intake in people with Muscle Loss and Muscle Weakness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Muscle Loss, Muscle Weakness, Quality of Life
- What is being tested?
- Oligonol intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Dec 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Loss, Muscle Weakness, Quality of Life
- Being tested
- Oligonol intake, Placebo
- Medical subject headings
- Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oligonol intakeDietary supplement
Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Oligonol intake group | Experimental | This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks. Receives: Dietary Supplement: Oligonol intake |
| Placebo group | Placebo comparator | This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline muscle after 12 weeks
Change from baseline muscle via MRI after 12 weeks.
Measured: 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.
Measured: baseline,12 weeks
Changes form baseline chair-stand after 12 weeks
measured by the time of chair-stand after 12 weeks.
Measured: baseline, 12 weeks
Changes form baseline muscle strength after 12 weeks
measured by hand grip distance after 12 weeks.
Measured: 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
Measured: 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
Measured: baseline, 12 weeks
Change from baseline endurance after 12 weeks
measured by 6-minute walk distance
Measured: baseline, 12 weeks
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Measured: baseline, 12 weeks
Change from baseline timed up and go test after 12 weeks
measured by timed up and go test (TUG)
Measured: baseline, 12 weeks
Secondary outcomes (16)
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline,12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: baseline,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Measured: 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
Measured: baseline,12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Measured: baseline,12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Measured: baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start4 Dec 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle LossStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liang-Kung Chen, MD.PhD., Principal investigator, Center for Healthy Longevity and Aging Sciences, National Yang Ming University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788577
- Sponsor's protocol ID
- 2018-05-004B
- Status last verified
- Feb 2020
- First submitted
- 19 Dec 2018
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oligonol to Cardiometabolic Risk and Muscular Health: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03788577
- Acronym / sponsor ID
- 2018-05-004B
- Conditions
- Muscle Loss, Muscle Weakness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oligonol intake group | Experimental | Dietary Supplement: Oligonol intakeThis experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oligonol intakeMajor intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day. | Dietary supplement | Oligonol intake group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Changes from baseline muscle after 12 weeks
Time frame: baseline,12 weeks
Change from baseline muscle via MRI after 12 weeks.
Changes from baseline fat content of leg after 12 weeks
Time frame: baseline,12 weeks
Change from baseline fat content of leg via MRI after 12 weeks.
Changes form baseline chair-stand after 12 weeks
Time frame: baseline, 12 weeks
measured by the time of chair-stand after 12 weeks.
Changes form baseline muscle strength after 12 weeks
Time frame: baseline, 12 weeks
measured by hand grip distance after 12 weeks.
Change from baseline Nutrition intake after 12 weeks
Time frame: baseline, 12 weeks
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Change from baseline depression after 12 weeks
Time frame: baseline, 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
Time frame: baseline, 12 weeks
measured by 6-minute walk distance
Change from baseline walking speed after 12 weeks
Time frame: baseline, 12 weeks
measured by six-meter walking speed
Change from baseline timed up and go test after 12 weeks
Time frame: baseline, 12 weeks
measured by timed up and go test (TUG)
16 secondary outcomes
Change from baseline numbers of Complete blood count after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks.
Time frame: baseline,12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks.
Time frame: baseline,12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of Leptin after 12 weeks
Time frame: baseline,12 weeks
Change from baseline concentration of urine protein after 12 weeks
Time frame: baseline,12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Muscle Loss
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A Study of Bimagrumab in Participants With HFpEF
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MF-300 for Treatment of Age-Related Sarcopenia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liang-Kung Chen, MD.PhD. principal investigator
Center for Healthy Longevity and Aging Sciences, National Yang Ming University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oligonol intake in people with Muscle Loss and Muscle Weakness, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline muscle after 12 weeks (time frame: baseline,12 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.