SarcopeniaNCT06144021
Efficacy and Safety of Kefir Whey Postbiotics
A study testing Whey postbiotics derived from kefir lactic acid bacteria in people with Sarcopenia, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
Research staff conduct screening tests only on applicants who provide written consent and select research subjects who meet the selection criteria. Study subjects will visit for the first time within 4 weeks from the screening visit to reexamine the suitability of the study subject selection/exclusion criteria and… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Whey postbiotics derived from kefir lactic acid bacteria
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Dec 2023to 31 Dec 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men and women aged 40 years or older at the time of screening test
- Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening
- Adult men and women with skeletal muscle mass less than 110% of the standard as measured by BIA (bioelectrical impedence analysis) at the time of screening test
Who cannot join
- Those with significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients
- Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test
- Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment.
- Those who show the following results in blood or urine tests:
- AST, ALT > 1.5 times the upper limit of the reference range
- Serum Creatinine > 1.4 mg/dL
Show all 24Show fewer
- Fasting blood sugar > 126mg/dL
- If there is 2+ or more proteinuria
- Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders)
- Those who consumed pro- or prebiotics within 1 month before the screening test
- Those who have taken protein supplements regularly for more than 3 months within 6 months before the screening test
- Those who received other investigational drugs within 1 month before the screening test
- Those who received antibiotics within 2 months before the screening test
- Those who are currently controlling their diet for disease management purposes
- Those with a history of gastrointestinal resection (excluding the appendix)
- Those who are performing or plan to perform regular resistance exercise
- People with vegetarian beliefs
- People with food allergies or restricted foods
- Persons with a history of diagnosed gastrointestinal disease (ex. ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel, and ileostomy)
- Those taking constipation or diarrhea medication
- Those who currently smoke
- Those whose BMI exceeds 30kg/m2 at the time of screening test
- Those who plan to control their weight within 6 months after screening
- Those who are likely to be uncooperative in this test or those who are determined by the researcher to be unable to proceed with the test
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Medical Center
Seoul
Jun Yup Kim, MD PhD
About this study
Official title: 12 Weeks, Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Kefir Whey Postbiotics
Research staff conduct screening tests only on applicants who provide written consent and select research subjects who meet the selection criteria. Study subjects will visit for the first time within 4 weeks from the screening visit to reexamine the suitability of the study subject selection/exclusion criteria and then be enrolled in the human application test. The participants will be randomly assigned to the kefir lactic acid bacteria-derived whey post-biotics group and the placebo group for the first time. Complete the baseline evaluation by the date of visit. Afterwards, the participants will consume whey postbiotics derived from kefir lactic acid bacteria and a placebo product twice a day, 3g per time, for 12 weeks, and visit the institution a total of four times to perform a grip strength test, DXA, etc. This survey will be conducted at Hanyang University Hospital. Research staff may conduct follow-up observations of study subjects as needed after final consumption of the kefir lactic acid bacteria-derived whey postbiotic group and placebo products or after early termination.
Read the detailed description
Purpose: Kefir (alcoholic fermented dairy product made by fermenting cow's milk, goat's milk, or sheep's milk) to determine the effect of 12 weeks of human consumption of whey postbiotics derived from lactic acid bacteria in improving muscle strength and intestinal microbiome in elderly people compared with placebo intake.
-Primary objective: To evaluate the effectiveness of whey postbiotics derived from kefir lactic acid bacteria compared to placebo intake through the results of the grip strength test for both hands.
-Secondary objective: To evaluate the effectiveness and safety of whey postbiotics derived from kefir lactobacilli for muscle strength improvement as assessed by dual energy x-ray absorptiometry (DXA), adipokines, myokines, and cytokines compared with placebo intake. The investigators aim to analyze the differences in the intestinal microbiome compared to placebo intake through fecal collection and NGS (Next Generation Sequencing).
Experimental product: Kefir lactic acid bacteria-derived whey postbiotics (oral intake of 6g per day (3g twice per day))
Control product: Flavor 2.7%, Calcium carbonate 13.8%, Lactose 41.3%, Maltodextrin 10.3%, Sugar 31.23%, Carboxy methyl cellulose 0.67% (oral intake of 6g per day (3g twice per day))
Number of subjects: In this human application test, in order to calculate the number of study subjects, the investigators referred to previous studies and calculated the lean mass gain (kg) of 3.3 ± 1.5 kg (mean ± SD) after consuming whey postbiotics derived from kefir lactic acid bacteria for 12 weeks. In the placebo group, it was assumed to be 1.8 ± 1.6 kg.
- The statistical hypothesis test of the evaluation variable is a two-sided test.
- The significance level is 5%. ③ The test power is maintained at 90% and the type 2 error is set at 0.2. ④ The ratio between the test group and the control group is divided at 1:1.
- The calculation of the number of subjects referred to existing research, and a T-test was performed using the G power program to use the mean of the statistical difference in muscle strength improvement between the two groups divided according to the intake of whey postbiotics derived from kefir lactic acid bacteria as the mean (test power) (1-β)=0.9, significance level (α)=0.05, effect size (ES)=0.97 (Cohen's d)). The total number of research subjects required for human application testing calculated through this is 48. Here, the investigators plan to recruit a total of 60 research subjects, assuming a dropout rate of 20%.
- Conditions
- Sarcopenia
- Being tested
- Whey postbiotics derived from kefir lactic acid bacteria, Placebo powder
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey postbiotics derived from kefir lactic acid bacteriaDietary supplement
Kefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics
Placebo powderDietary supplement
A powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection.
| Study group | Role | What they receive |
|---|---|---|
| Kefir Postbiotics Group | Experimental | * 30 healthy adult participants
* Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor
* Period of use: 12 months
* Storage method: Store at room temperature
* Manufacturing method: The whey postbiotics derived from kefir lactic acid bacteria used in the test food are produced in the laboratory at Hanyang University, and additional ingredients are purchased from finished products. Laboratory collects the ingredients and delivers them to the manufacturer, Neo Natural, to manufacture them so that there are no differences in properties and formulations. Receives: Dietary Supplement: Whey postbiotics derived from kefir lactic acid bacteria |
| Control Group | Placebo comparator | * 30 healthy adult participants
* Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor
* Period of use: 12 months
* Storage method: Store at room temperature
* Manufacturing method: The same product without whey postbiotics. Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength test for both hands
Handgrip strength should be measured using the JAMAR grip dynamometer (Jamar, Plus+ Digital Hand Dynamometer, Preferred, USA). While the research subject is sitting, the grip strength of both hands is measured three times each, and the average value is taken as the representative value. The unit of grip strength is kg.
Measured: 1) Day 0, 2) end of 12 weeks
Dual energy xray absorptiometry
Dexa imaging measures the whole body, lean mass, body fat mass, and bone mineral content using Hanyang University Hospital's DXA (Discovery W DEXA) equipment after fasting for more than 8 hours. Measurements will be taken with the study subject standing upright, rotating both feet inward about 15 degrees, and placing both hands next to the waist. Here, the investigators will measure skeletal muscle mass (SMM, kg) by subtracting bone mineral content (BMC) from lean body mass. And the SMM and the height (m) will be combined to report skeletal muscle mass index (SMMI) in kg/m^2 unit.
Measured: 1) Day 0, 2) end of 12 weeks
Secondary outcomes (2)
Biomarkers from blood
All in ng/mL
: 1) adipokines (leptin, adiponectin) 2) myokines (myostatin, irisin) 3) lipid analysis (TG, T-C, HDL-C, LDL-C) 4) cytokines (CRP, IL-2, IL-6, IL-1β, TNF-α, IGF-1)
Measured: 1) Day 0, 2) end of 12 weeks
Confirmation of intestinal microorganisms
Stool collection is collected directly by the research subject 1 day before (24 hours) before the start of consumption of whey postbiotics derived from kefir lactic acid bacteria and after the last intake, and stored at a frozen temperature (-20℃ or lower) until the first and third visits. do. Research staff collect stool samples, store them frozen (-70°C), and then perform next-generation sequencing (NGS analysis).
Measured: 1) Day 0, 2) end of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start15 Dec 2023
- Primary completion30 Oct 2024 (estimated)
- Study completion31 Dec 2024 (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.
- 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
- Model description
- Double-blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ottogi Ham Taiho Foundation, Hanyang University
- Responsible party
- Principal investigator, Jun Yup Kim, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144021
- Sponsor's protocol ID
- HYUH 2023-07-059-008
- Status last verified
- Jul 2024
- First submitted
- 9 Nov 2023
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12 Weeks, Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Kefir Whey Postbiotics
- ClinicalTrials.gov ID
- NCT06144021
- Acronym / sponsor ID
- HYUH 2023-07-059-008
- Conditions
- Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- Ottogi Ham Taiho Foundation, Hanyang University
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Nov 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.
Research staff conduct screening tests only on applicants who provide written consent and select research subjects who meet the selection criteria. Study subjects will visit for the first time within 4 weeks from the screening visit to reexamine the suitability of the study subject selection/exclusion criteria and then be enrolled in the human application test. The participants will be randomly assigned to the kefir lactic acid bacteria-derived whey post-biotics group and the placebo group for the first time. Complete the baseline evaluation by the date of visit. Afterwards, the participants will consume whey postbiotics derived from kefir lactic acid bacteria and a placebo product twice a day, 3g per time, for 12 weeks, and visit the institution a total of four times to perform a grip strength test, DXA, etc. This survey will be conducted at Hanyang University Hospital. Research staff may conduct follow-up observations of study subjects as needed after final consumption of the kefir lactic acid bacteria-derived whey postbiotic group and placebo products or after early termination.
Detailed description
Purpose: Kefir (alcoholic fermented dairy product made by fermenting cow's milk, goat's milk, or sheep's milk) to determine the effect of 12 weeks of human consumption of whey postbiotics derived from lactic acid bacteria in improving muscle strength and intestinal microbiome in elderly people compared with placebo intake.
-Primary objective: To evaluate the effectiveness of whey postbiotics derived from kefir lactic acid bacteria compared to placebo intake through the results of the grip strength test for both hands.
-Secondary objective: To evaluate the effectiveness and safety of whey postbiotics derived from kefir lactobacilli for muscle strength improvement as assessed by dual energy x-ray absorptiometry (DXA), adipokines, myokines, and cytokines compared with placebo intake. The investigators aim to analyze the differences in the intestinal microbiome compared to placebo intake through fecal collection and NGS (Next Generation Sequencing).
Experimental product: Kefir lactic acid bacteria-derived whey postbiotics (oral intake of 6g per day (3g twice per day))
Control product: Flavor 2.7%, Calcium carbonate 13.8%, Lactose 41.3%, Maltodextrin 10.3%, Sugar 31.23%, Carboxy methyl cellulose 0.67% (oral intake of 6g per day (3g twice per day))
Number of subjects: In this human application test, in order to calculate the number of study subjects, the investigators referred to previous studies and calculated the lean mass gain (kg) of 3.3 ± 1.5 kg (mean ± SD) after consuming whey postbiotics derived from kefir lactic acid bacteria for 12 weeks. In the placebo group, it was assumed to be 1.8 ± 1.6 kg.
- The statistical hypothesis test of the evaluation variable is a two-sided test.
- The significance level is 5%. ③ The test power is maintained at 90% and the type 2 error is set at 0.2. ④ The ratio between the test group and the control group is divided at 1:1.
- The calculation of the number of subjects referred to existing research, and a T-test was performed using the G power program to use the mean of the statistical difference in muscle strength improvement between the two groups divided according to the intake of whey postbiotics derived from kefir lactic acid bacteria as the mean (test power) (1-β)=0.9, significance level (α)=0.05, effect size (ES)=0.97 (Cohen's d)). The total number of research subjects required for human application testing calculated through this is 48. Here, the investigators plan to recruit a total of 60 research subjects, assuming a dropout rate of 20%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Kefir Postbiotics Group | Experimental | Dietary Supplement: Whey postbiotics derived from kefir lactic acid bacteria* 30 healthy adult participants * Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor * Period of use: 12 months * Storage method: Store at room temperature * Manufacturing method: The whey postbiotics derived from kefir lactic acid bacteria used in the test food are produced in the laboratory at Hanyang University, and additional ingredients are purchased from finished products. Laboratory collects the ingredients and delivers them to the manufacturer, Neo Natural, to manufacture them so that there are no differences in properties and formulations. |
| Control Group | Placebo comparator | Dietary Supplement: Placebo powder* 30 healthy adult participants * Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor * Period of use: 12 months * Storage method: Store at room temperature * Manufacturing method: The same product without whey postbiotics. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men and women aged 40 years or older at the time of screening test
- Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening
- Adult men and women with skeletal muscle mass less than 110% of the standard as measured by BIA (bioelectrical impedence analysis) at the time of screening test
Key exclusion criteria (24 listed)
- Those with significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients
- Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test
- Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment.
- Those who show the following results in blood or urine tests:
- If there is 2+ or more proteinuria
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 |
|---|---|---|
| Whey postbiotics derived from kefir lactic acid bacteriaKefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics | Dietary supplement | Kefir Postbiotics Group |
| Placebo powderA powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection. | Dietary supplement | Control Group |
Primary outcome
Grip strength test for both hands
Time frame: 1) Day 0, 2) end of 12 weeks
Handgrip strength should be measured using the JAMAR grip dynamometer (Jamar, Plus+ Digital Hand Dynamometer, Preferred, USA). While the research subject is sitting, the grip strength of both hands is measured three times each, and the average value is taken as the representative value. The unit of grip strength is kg.
Dual energy xray absorptiometry
Time frame: 1) Day 0, 2) end of 12 weeks
Dexa imaging measures the whole body, lean mass, body fat mass, and bone mineral content using Hanyang University Hospital's DXA (Discovery W DEXA) equipment after fasting for more than 8 hours. Measurements will be taken with the study subject standing upright, rotating both feet inward about 15 degrees, and placing both hands next to the waist. Here, the investigators will measure skeletal muscle mass (SMM, kg) by subtracting bone mineral content (BMC) from lean body mass. And the SMM and the height (m) will be combined to report skeletal muscle mass index (SMMI) in kg/m^2 unit.
2 secondary outcomes
Biomarkers from blood
Time frame: 1) Day 0, 2) end of 12 weeks
Confirmation of intestinal microorganisms
Time frame: 1) Day 0, 2) end of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey postbiotics derived from kefir lactic acid bacteria in people with Sarcopenia, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 24 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 10 Jul 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Yup Kim, MD, MS (821030385432, futurer22c@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength test for both hands (time frame: 1) Day 0, 2) end of 12 weeks). The study lists 2 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 10 Jul 2024.