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RECRUITING

NCT06144021

Efficacy and Safety of Kefir Whey Postbiotics

Sponsor: Hanyang University Seoul Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-12-15

Completion Date

2024-12-31

Last Updated

2024-07-10

Healthy Volunteers

Yes

Conditions

Sarcopenia

Interventions

DIETARY_SUPPLEMENT

Whey postbiotics derived from kefir lactic acid bacteria

Kefir (alcoholic fermented dairy product made by fermenting cow, goat, or sheep milk) whey derived from lactic acid bacteria postbiotics

DIETARY_SUPPLEMENT

Placebo powder

A powder product including Flavor, Calcium carbonate, Lactose, Maltodextrin, Sugar, Carboxy methyl cellulose. This cannot be distinguished from the postbiotics by inspection.

Inclusion Criteria: 1. Adult men and women aged 40 years or older at the time of screening test 2. Adult men and women with a Charlson Comorbidity Index (CCI) score of 0 at the time of screening 3. 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 Exclusion Criteria: 1. Those with significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients 2. Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test 3. Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment. 4. Those who show the following results in blood or urine tests: * AST, ALT \> 1.5 times the upper limit of the reference range * Serum Creatinine \> 1.4 mg/dL * Fasting blood sugar \> 126mg/dL 5. If there is 2+ or more proteinuria 6. Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders) 7. Those who consumed pro- or prebiotics within 1 month before the screening test 8. Those who have taken protein supplements regularly for more than 3 months within 6 months before the screening test 9. Those who received other investigational drugs within 1 month before the screening test 10. Those who received antibiotics within 2 months before the screening test 11. Those who are currently controlling their diet for disease management purposes 12. Those with a history of gastrointestinal resection (excluding the appendix) 13. Those who are performing or plan to perform regular resistance exercise 14. People with vegetarian beliefs 15. People with food allergies or restricted foods 16. Persons with a history of diagnosed gastrointestinal disease (ex. ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel, and ileostomy) 17. Those taking constipation or diarrhea medication 18. Those who currently smoke 19. Those whose BMI exceeds 30kg/m2 at the time of screening test 20. Those who plan to control their weight within 6 months after screening 21. Those who are likely to be uncooperative in this test or those who are determined by the researcher to be unable to proceed with the test

Locations (1)

Hanyang University Medical Center

Seoul, South Korea