12 Weeks, Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Kefir Whey Postbiotics

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• Adult men and women aged 40 years or older at the time of screening test

• Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening

• 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

Locations
Other Locations
Republic of Korea
Hanyang University Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jun Yup Kim, MD, MS
futurer22c@gmail.com
821030385432
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 60
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Ottogi Ham Taiho Foundation, Hanyang University
Leads: Hanyang University Seoul Hospital

This content was sourced from clinicaltrials.gov