An interventional study of Whey postbiotics derived from kefir lactic acid bacteria and Placebo powder in Sarcopenia, sponsored by Hanyang University Seoul Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Hanyang University Seoul Hospital · Not applicable, Interventional, and Supportive care
Among 40 studies in Sarcopenia with a site in Korea, Republic of — 13 open to participants now, 15 under way, none of them phase 3. Sarcopenia · Korea, Republic of.
Among the 40 studies in Sarcopenia with a site in Korea, Republic of, this one is the 21st largest by planned enrollment of the 29 interventional ones that give a count, is one of 6 that started in 2023, is one of 19 with no phase, reaches primary completion later than 1 of the 14 other live ones, and was the 24th registered.
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
Browse Sarcopenia studies →13 of the 40 studies in Sarcopenia with a site in Korea, Republic of are open now. Recruiting first, the newest first:
Pusan National University Yangsan Hospital · Sites in Korea, Republic of
Pluto Inc. · Sites in Korea, Republic of
Animuscure Inc. · Sites in Korea, Republic of
Seoul National University Bundang Hospital · Sites in Korea, Republic of
Seoul National University Hospital · Sites in Korea, Republic of
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 247 Sarcopenia studies recruiting now, 153 (62%) set no upper age limit and 33 (13%) stop at 75 or younger; 9 take children under 18; 65 take healthy volunteers.
This study: 40 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 6 · Phase 4 3
First in 2009; this study’s year is marked. 6 started in 2023.
This study's planned enrollment of 60 is close to the median of 60 across 855 interventional studies indexed under Sarcopenia.
Median enrollment 80 across the 29 interventional studies, 150 across the 11 observational. Of the 19 that completed or were terminated, 2 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 40 have an industry lead sponsor. The 10 most frequent:
Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Hanyang University Seoul Hospital has 1 study filed under Sarcopenia — fewer than ten, so there is no comparison to draw.
3 of the studies in Sarcopenia with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07634523Seoul National University HospitalBranched Chain Amino Acids for Sarcopenia in Patients Undergoing Total Knee Arthroplasty | 2027-05-31 |
| NCT07749118Pusan National University Yangsan HospitalHB05P on Muscle Health | 2027-06-29 |
| NCT07390552Pluto Inc.A Study of PLH-2301 in Subjects With Sarcopenia | 2027-06-30 |
Among the 40 studies in Sarcopenia with a site in Korea, Republic of, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Those who show the following results in blood or urine tests:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* 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.
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 same product without whey postbiotics.
Dietary Supplement: Placebo powder
Kefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics
A powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection.
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.
Time frame: 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.
Time frame: 1) Day 0, 2) end of 12 weeks
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)
Time frame: 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).
Time frame: 1) Day 0, 2) end of 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2023 (actual). Primary completion is estimated for Oct 2024, 10 months after the start.
Of 492 non-industry interventional studies with no phase under Sarcopenia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 34. This study's planned 10 months is below that.
Counting every sponsor, half of 503 studies reached it within 18 months; a quarter within 8 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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Hanyang University Seoul Hospital