SarcopeniaNCT05926375
Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
A study testing HINEX Jelly ( jelly high protein supplement) in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- HINEX Jelly ( jelly high protein supplement)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2022to 28 Jun 2023
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 40-85 years old, middle-aged and elderly subjects with possible sarcopenia or sarcopenia. According to AWGS 2019, possible sarcopenia is defined as (1) handgrip strength < 28 kg in men and < 18 kg in women or (2) 5-time chair stand test ≥ 12 seconds; sarcopenia is defined as meet (1) or (2) plus appendicular skeletal muscle mass index (ASMI) < 7.0 kg/m2 in men and < 5.7 kg/m2 in women.
Who cannot join
- BMI>35 kg/m2, Taking any special diet (i.e. vegan), be allergic to ingredient (i.e. milk or soy bean) and any seriously acute or chronic lung, liver, kidney, gastrointestinal, cancers diseases history.
Trial locations and contacts
1 site in 1 country.
About this study
HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. The screening, recruitment and trial period were carried out from Feb, 2022 to Mar, 2023. Patients were randomized to either a self-controlled phase,which intake 400~500 kcal breakfast, or a supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks. After a 4-week washout they cross over to the alternate treatment. The anthropometric measurements, sarcopenia parameters, nutritional assessment and hematology assessment data were measured at the week 0,8,12,20 and 24-hour dietary record were recorded at week 1,8,13,20.
Read the detailed description
Parameters of sarcopenia, including the muscle mass assessment, handgrip strength and physical performance assessment.Muscle mass and body composition were measured by bioelectrical impedance analysis (BIA). A hand dynamometer was used to measure handgrip strength. Physical performance was measured by short physical performance battery (SPPB), 6-meter gait speed and 5-time chair stand test. Mini nutritional assessment (MNA) used to measure nutritional status. The hematology assessment including total protein, albumin, pre-albumin, transferrin, c-reactive protein (CRP), vitamin D, calcium, glucose, insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR), total cholesterol, triacylglycerol, creatinine, creatine-kinase, alkaline phosphatase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) and complete blood count.
- Conditions
- Sarcopenia
- Being tested
- HINEX Jelly ( jelly high protein supplement)
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HINEX Jelly ( jelly high protein supplement)Dietary supplement
In self-controlled phase,which intake 400~500 kcal breakfast, or in supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| first intervention group (Supp-Con sequence) | Experimental | The first intervention group used HINEX Jelly as daily breakfast during the first to 8th weeks of the experiment, the 9th to 12th week is the wash out period, the 13th to the 20th week is the selfcontrol period. Receives: Dietary Supplement: HINEX Jelly ( jelly high protein supplement) |
| post intervention group (Con-Supp sequence) | Experimental | the post-intervention group is in the first to the 8th week of self-control period,the 9th to 12th week is the wash out period, and the 13th to the 20th week is used HINEX Jelly as daily breakfast. Receives: Dietary Supplement: HINEX Jelly ( jelly high protein supplement) |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle mass
the change of muscle mass and measured via bioelectrical impedance analysis(BIA)
Measured: week 0,8,12,20
hand grip strength
the change of hand grip strength as the marker of muscle strength.Measured via hand grip dynamometry.
Measured: week 0,8,12,20
5-time chair stand test
the change of 5-time chair stand test as the marker of physical performance.
Measured: week 0,8,12,20
Secondary outcomes (3)
short physical performance battery
the change of short physical performance battery as the marker of physical performance.
Measured: week 0,8,12,20
6-meter gait speed
the change of 6-meter gait speed as the marker of physical performance.
Measured: week 0,8,12,20
Mini nutritional assessment
the change of 6-meter gait speed as the marker of nutritional status.
Measured: week 0,8,12,20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Jan 2022
- Primary completion24 Mar 2023
- Study completion28 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Taipei Medical 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The experiment lasted for 20 weeks, including 8 weeks self-controlled phase, 8 weeks supplement phase and 4 weeks washout period. In self-controlled phase would intake 400\~500 kcal breakfast and in supplement phase consume one servings of jelly high protein supplement with 100\~200 kcal food at breakfast. Subjects were randomly divided into "first intervention group" and "post intervention group". The first intervention group used HINEX Jelly as daily breakfast during the first to 8th weeks of the experiment, the 9th to 12th week is the wash out period, the 13th to the 20th week is the selfcontrol period; the post-intervention group is in the first to the 8th week of self-control period,the 9th to 12th week is the wash out period, and the 13th to the 20th week is used HINEX Jelly as daily breakfast, as well as maintained their regular diet and medication, but do exercise lifestyle modification during 20-week experimental period.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Otsuka Pharm. Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Jane C-J Chao, Ph.D., Study chair, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926375
- Sponsor's protocol ID
- N202112052
- Status last verified
- Jan 2023
- First submitted
- 19 Jun 2023
- Last updated
- 3 Jul 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 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HINEX Jelly on Nutritional Status in People With Possible Sarcopenia or Sarcopenia
- ClinicalTrials.gov ID
- NCT05926375
- Acronym / sponsor ID
- N202112052
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Taiwan Otsuka Pharm. Co., Ltd
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 28 Jun 2023 (estimated)
- First posted
- 3 Jul 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.
HINEX Jelly is a jelly high protein supplement. This report is to investigate whether jelly high protein supplement can achieve greater muscle mass, muscle strength, physical performance and nutritional status in sarcopenia or possible sarcopenia subjects. It is 20 weeks randomized, crossover, self-controlled trials. The screening, recruitment and trial period were carried out from Feb, 2022 to Mar, 2023. Patients were randomized to either a self-controlled phase,which intake 400~500 kcal breakfast, or a supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks. After a 4-week washout they cross over to the alternate treatment. The anthropometric measurements, sarcopenia parameters, nutritional assessment and hematology assessment data were measured at the week 0,8,12,20 and 24-hour dietary record were recorded at week 1,8,13,20.
Detailed description
Parameters of sarcopenia, including the muscle mass assessment, handgrip strength and physical performance assessment.Muscle mass and body composition were measured by bioelectrical impedance analysis (BIA). A hand dynamometer was used to measure handgrip strength. Physical performance was measured by short physical performance battery (SPPB), 6-meter gait speed and 5-time chair stand test. Mini nutritional assessment (MNA) used to measure nutritional status. The hematology assessment including total protein, albumin, pre-albumin, transferrin, c-reactive protein (CRP), vitamin D, calcium, glucose, insulin, homeostasis model assessment-estimated insulin resistance (HOMA-IR), total cholesterol, triacylglycerol, creatinine, creatine-kinase, alkaline phosphatase, glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT) and complete blood count.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experiment lasted for 20 weeks, including 8 weeks self-controlled phase, 8 weeks supplement phase and 4 weeks washout period. In self-controlled phase would intake 400~500 kcal breakfast and in supplement phase consume one servings of jelly high protein supplement with 100~200 kcal food at breakfast. Subjects were randomly divided into "first intervention group" and "post intervention group". The first intervention group used HINEX Jelly as daily breakfast during the first to 8th weeks of the experiment, the 9th to 12th week is the wash out period, the 13th to the 20th week is the selfcontrol period; the post-intervention group is in the first to the 8th week of self-control period,the 9th to 12th week is the wash out period, and the 13th to the 20th week is used HINEX Jelly as daily breakfast, as well as maintained their regular diet and medication, but do exercise lifestyle modification during 20-week experimental period.
| Arm | Type | Receives |
|---|---|---|
| first intervention group (Supp-Con sequence) | Experimental | Dietary Supplement: HINEX Jelly ( jelly high protein supplement)The first intervention group used HINEX Jelly as daily breakfast during the first to 8th weeks of the experiment, the 9th to 12th week is the wash out period, the 13th to the 20th week is the selfcontrol period. |
| post intervention group (Con-Supp sequence) | Experimental | Dietary Supplement: HINEX Jelly ( jelly high protein supplement)the post-intervention group is in the first to the 8th week of self-control period,the 9th to 12th week is the wash out period, and the 13th to the 20th week is used HINEX Jelly as daily breakfast. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 40-85 years old, middle-aged and elderly subjects with possible sarcopenia or sarcopenia. According to AWGS 2019, possible sarcopenia is defined as (1) handgrip strength < 28 kg in men and < 18 kg in women or (2) 5-time chair stand test ≥ 12 seconds; sarcopenia is defined as meet (1) or (2) plus appendicular skeletal muscle mass index (ASMI) < 7.0 kg/m2 in men and < 5.7 kg/m2 in women.
Key exclusion criteria (1 listed)
- BMI>35 kg/m2, Taking any special diet (i.e. vegan), be allergic to ingredient (i.e. milk or soy bean) and any seriously acute or chronic lung, liver, kidney, gastrointestinal, cancers diseases history.
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 Jelly ( jelly high protein supplement)In self-controlled phase,which intake 400~500 kcal breakfast, or in supplement phase consume one servings of jelly high protein supplement (303 kcal, 15 g protein and 2400 mg BCAA per serving) and 100~200 kcal food at breakfast per day, for 8 weeks. | Dietary supplement | first intervention group (Supp-Con sequence), post intervention group (Con-Supp sequence) |
Primary outcome
muscle mass
Time frame: week 0,8,12,20
the change of muscle mass and measured via bioelectrical impedance analysis(BIA)
hand grip strength
Time frame: week 0,8,12,20
the change of hand grip strength as the marker of muscle strength.Measured via hand grip dynamometry.
5-time chair stand test
Time frame: week 0,8,12,20
the change of 5-time chair stand test as the marker of physical performance.
3 secondary outcomes
short physical performance battery
Time frame: week 0,8,12,20
6-meter gait speed
Time frame: week 0,8,12,20
Mini nutritional assessment
Time frame: week 0,8,12,20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Jane C-J Chao, Ph.D. study chair
Taipei Medical University, Taiwan, R.O.C.
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 ( jelly high protein supplement) in people with Sarcopenia, run by Taipei Medical 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 1 inclusion and 1 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 3 Jul 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. 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?
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?
muscle mass (time frame: week 0,8,12,20). The study lists 3 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 3 Jul 2023.