Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-12-15
2024-12-31
Brief Summary
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Detailed Description
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-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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
* In general, double blinding should not be lifted until all research subjects have completed the test and the data is locked. However, in the case of an emergency such as a health problem of a research subject during intervention, double blinding may be lifted at the discretion of the researcher. In this case, the research person must contact the principal investigator as quickly as possible.
* The date, time, and reason for lifting double blinding must be documented in an appropriate location in the case record and supporting documents. A copy of the double-blind code release confirmation document received from the principal investigator must be kept in the supporting documents.
Study Groups
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Kefir Postbiotics Group
* 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.
Whey postbiotics derived from kefir lactic acid bacteria
Kefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics
Control Group
* 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.
Placebo powder
A powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection.
Interventions
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Whey postbiotics derived from kefir lactic acid bacteria
Kefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics
Placebo powder
A powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection.
Eligibility Criteria
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Inclusion Criteria
2. Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening
3. 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
Exclusion Criteria
2. Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test
3. Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment.
4. 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
* Fasting blood sugar \> 126mg/dL
5. If there is 2+ or more proteinuria
6. Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders)
7. Those who consumed pro- or prebiotics within 1 month before the screening test
8. Those who have taken protein supplements regularly for more than 3 months within 6 months before the screening test
9. Those who received other investigational drugs within 1 month before the screening test
10. Those who received antibiotics within 2 months before the screening test
11. Those who are currently controlling their diet for disease management purposes
12. Those with a history of gastrointestinal resection (excluding the appendix)
13. Those who are performing or plan to perform regular resistance exercise
14. People with vegetarian beliefs
15. People with food allergies or restricted foods
16. 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)
17. Those taking constipation or diarrhea medication
18. Those who currently smoke
19. Those whose BMI exceeds 30kg/m2 at the time of screening test
20. Those who plan to control their weight within 6 months after screening
21. 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
40 Years
ALL
Yes
Sponsors
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Ottogi Ham Taiho Foundation
UNKNOWN
Hanyang University
OTHER
Hanyang University Seoul Hospital
OTHER
Responsible Party
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Jun Yup Kim
Clinical Assistant Professor
Locations
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Hanyang University Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Jun Yup Kim, MD PhD
Role: primary
Other Identifiers
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HYUH 2023-07-059-008
Identifier Type: -
Identifier Source: org_study_id
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