An interventional study of Whey postbiotics derived from kefir lactic acid bacteria and Placebo powder in Sarcopenia, sponsored by Hanyang University. Enrolling by invitation at 1 site in Korea, Republic of. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Hanyang University · Not applicable, Interventional, and Treatment
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. 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.
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
1,329 studies on the registry are indexed under Sarcopenia; 420 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 855 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Hanyang University is the lead sponsor of 52 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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, bone mineral content, and height 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 from lean body mass. And the SMM (kg) and the height (m) will be combined to report skeletal muscle mass index (SMMI) in kg/m\^2 unit.
Time frame: 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: 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: 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 Apr 2024, 4 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 4 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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