Nutrition, HealthyNCT05917353
A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity
A study testing Hinex Jelly in people with Nutrition, Healthy and Muscle Weakness, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy, Muscle Weakness, Elderly
- What is being tested?
- Hinex Jelly
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 30 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults over the age of 50 (include 50 years old).
- Can cooperate with the study.
- No surgical intervention within 3 months.
Who cannot join
- Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study.
- Those who are equipped with pacemakers or internal electronic medical devices.
- Pregnant women.
- Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.).
- Allergic to dairy or soy products.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University Hospital
Kaohsiung City, 807
Chen-Cheng Yang, MD, +886-7-803-6783 ext. 3460, kmshhinexjelly@gmail.com
About this study
Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. It is characterized by persistent and general loss of skeletal muscle mass and function throughout the body, which may lead to disability, decreased quality of life, and even inability to take care of yourself and an increased risk of death. Human skeletal muscle decreases with age. After the age of 40, muscle mass will be lost at a rate of 8% per decade; after the age of 70, it will be lost at a faster rate of 15% per decade in average. Although all elderly will lose muscle mass due to aging, the degree and speed of loss vary from person to person. In addition to aging, it may also be caused by chronic diseases.
Exercise intervention and nutritional intervention are the first choices for sarcopenia intervention. Regarding nutritional requirements, the elderly need at least 15 grams of essential amino acids per day for muscle building. Among them, leucine is the most important, which can increase protein production and reduce decomposition. Foods rich in leucine include soybeans, fish or beef. However, elderly people may not be able to get enough protein from their daily diet smoothly, often because of dysphagia, such as dental problems or chewing and swallowing problems. Therefore, oral nutritional supplements are relatively important for the improvement of muscle mass. Nutritional Supplement Hinex Jelly has 303 calories per serving, contains up to 15g of high-quality protein and a high amount of branched-chain amino acids, which is beneficial for muscle synthesis and tissue repair, plus a variety of minerals, vitamins, water-soluble dietary fiber, hydrolyzed collagen and other ingredients can strengthen nutritional supplements, maintain good health.
In summary, this study intends to explore the effect of Hinex Jelly nutritional supplemental intervention on muscle mass quality and quantity changes by means of randomized intervention and controlled trials.
- Conditions
- Nutrition, Healthy, Muscle Weakness, Elderly
- Being tested
- Hinex Jelly
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hinex JellyDietary supplement
- Name: Hinex Jelly
- Dosage form: Semi-solid jelly/ A-114001297-00000-2
- Dose(s): 300g/pack (per serving)
- Dosing schedule: one pack (serving) per day
- Mechanism of action: Nutritional supplement semi-solid food (content 61-91g/100g, protein 4.0-6.0/100g, saturated fatty acid 0.72-1.08g/100g, carbohydrate 12.56-18.84g/100g, dietary fiber 1.0-1.4g/100g), It is used as a nutritional supplement food.
| Study group | Role | What they receive |
|---|---|---|
| Hinex Jelly Nutritional Supplement Intervention Group | Experimental | Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), diet and exercise health education was given, with daily intervention of Hinex Jelly nutritional supplements 1 serving per day during 0th to 8th Week; Receives: Dietary Supplement: Hinex Jelly |
| Routine care group | No intervention | Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), the subjects were given regular dietary and exercise health education. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Appendicular skeletal muscle mass index at 8 weeks
Appendicular skeletal muscle mass index assessed using the Inbody S10
Measured: 8 weeks after the first session
Change from Baseline handgrip strength at 8 weeks
assessed with a Jamar handheld dynamometer in kilograms
Measured: 8 weeks after the first session
Change from Baseline performance on the 5-repetition sit-to-stand test at 8 weeks
assessed in seconds
Measured: 8 weeks after the first session
Change from Baseline performance on 6-metre walk test at 8 weeks
assessed in seconds
Measured: 8 weeks after the first session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Mar 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917353
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220124
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 18 Jan 2024
- 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 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity
- ClinicalTrials.gov ID
- NCT05917353
- Acronym / sponsor ID
- KMUHIRB-F(I)-20220124
- Conditions
- Nutrition, Healthy, Muscle Weakness, Elderly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Jun 2023 (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.
Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. It is characterized by persistent and general loss of skeletal muscle mass and function throughout the body, which may lead to disability, decreased quality of life, and even inability to take care of yourself and an increased risk of death. Human skeletal muscle decreases with age. After the age of 40, muscle mass will be lost at a rate of 8% per decade; after the age of 70, it will be lost at a faster rate of 15% per decade in average. Although all elderly will lose muscle mass due to aging, the degree and speed of loss vary from person to person. In addition to aging, it may also be caused by chronic diseases.
Exercise intervention and nutritional intervention are the first choices for sarcopenia intervention. Regarding nutritional requirements, the elderly need at least 15 grams of essential amino acids per day for muscle building. Among them, leucine is the most important, which can increase protein production and reduce decomposition. Foods rich in leucine include soybeans, fish or beef. However, elderly people may not be able to get enough protein from their daily diet smoothly, often because of dysphagia, such as dental problems or chewing and swallowing problems. Therefore, oral nutritional supplements are relatively important for the improvement of muscle mass. Nutritional Supplement Hinex Jelly has 303 calories per serving, contains up to 15g of high-quality protein and a high amount of branched-chain amino acids, which is beneficial for muscle synthesis and tissue repair, plus a variety of minerals, vitamins, water-soluble dietary fiber, hydrolyzed collagen and other ingredients can strengthen nutritional supplements, maintain good health.
In summary, this study intends to explore the effect of Hinex Jelly nutritional supplemental intervention on muscle mass quality and quantity changes by means of randomized intervention and controlled trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hinex Jelly Nutritional Supplement Intervention Group | Experimental | Dietary Supplement: Hinex JellyWeek 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), diet and exercise health education was given, with daily intervention of Hinex Jelly nutritional supplements 1 serving per day during 0th to 8th Week; |
| Routine care group | No intervention | –Week 0th, Week 4th (14 days before and after), Week 8th (14 days before and after), Week 12th (14 days before and after), the subjects were given regular dietary and exercise health education. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults over the age of 50 (include 50 years old).
- Can cooperate with the study.
- No surgical intervention within 3 months.
Key exclusion criteria (5 listed)
- Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study.
- Those who are equipped with pacemakers or internal electronic medical devices.
- Pregnant women.
- Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.).
- Allergic to dairy or soy products.
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 |
|---|---|---|
| Hinex Jelly1. Name: Hinex Jelly 2. Dosage form: Semi-solid jelly/ A-114001297-00000-2 3. Dose(s): 300g/pack (per serving) 4. Dosing schedule: one pack (serving) per day 5. Mechanism of action: Nutritional supplement semi-solid food (content 61-91g/100g, protein 4.0-6.0/100g, saturated fatty acid 0.72-1.08g/100g, carbohydrate 12.56-18.84g/100g, dietary fiber 1.0-1.4g/100g), It is used as a nutritional supplement food. | Dietary supplement | Hinex Jelly Nutritional Supplement Intervention Group |
Primary outcome
Change from Baseline Appendicular skeletal muscle mass index at 8 weeks
Time frame: 8 weeks after the first session
Appendicular skeletal muscle mass index assessed using the Inbody S10
Change from Baseline handgrip strength at 8 weeks
Time frame: 8 weeks after the first session
assessed with a Jamar handheld dynamometer in kilograms
Change from Baseline performance on the 5-repetition sit-to-stand test at 8 weeks
Time frame: 8 weeks after the first session
assessed in seconds
Change from Baseline performance on 6-metre walk test at 8 weeks
Time frame: 8 weeks after the first session
assessed in seconds
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Nutrition, Healthy
RecruitingPhase 1
A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity
Overweight and/or Obesity, Healthy Participants
Not yet recruitingPhase 1
A Phase I Clinical Trial of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of UBT48128 Tablets in Healthy Participants
Overweight , Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Active, not recruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08653944 in Otherwise Healthy Chinese Adults With Overweight or Obesity
Overweight, Obesity
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hinex Jelly in people with Nutrition, Healthy and Muscle Weakness, run by Kaohsiung Medical University Chung-Ho Memorial Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Cheng Yang, MD (+886-7-803-6783 ext. 3460, kmshhinexjelly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Appendicular skeletal muscle mass index at 8 weeks (time frame: 8 weeks after the first session). The study lists 4 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 18 Jan 2024.