Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144021
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2023-11-09
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:
RECRUITING
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:
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 selectionexclusion 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 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