Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2025-12-17 @ 12:44 AM
Study NCT ID:
NCT06144021
Status:
None
Last Update Posted:
2024-07-10 00:00:00
First Post:
2023-11-09 00:00:00
Brief Title:
Efficacy and Safety of Kefir Whey Postbiotics
Sponsor:
Hanyang University Seoul Hospital
Organization:
Hanyang University Seoul Hospital
Study Overview
Official Title:
12 Weeks, Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Kefir Whey Postbiotics
Status:
None
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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%.
-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%.
Detailed Description:
Purpose Kefir alcoholic fermented dairy product made by fermenting cows milk goats milk or sheeps 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 27 Calcium carbonate 138 Lactose 413 Maltodextrin 103 Sugar 3123 Carboxy methyl cellulose 067 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 33 15 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 18 16 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 02 ④ The ratio between the test group and the control group is divided at 11
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-β09 significance level α005 effect size ES097 Cohens 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
-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 27 Calcium carbonate 138 Lactose 413 Maltodextrin 103 Sugar 3123 Carboxy methyl cellulose 067 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 33 15 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 18 16 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 02 ④ The ratio between the test group and the control group is divided at 11
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-β09 significance level α005 effect size ES097 Cohens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None