Efficacy and Safety of Kefir Whey Postbiotics
12 Weeks, Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Kefir Whey Postbiotics
Hanyang University Seoul Hospital
60 participants
Dec 15, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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
Exclusion Criteria24
- Those with significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients
- Those who participated in other human application tests, diet, or exercise programs within 3 months before the screening test
- Persons with clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal and urinary, neuropsychiatric, or gastrointestinal diseases requiring treatment.
- 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
- If there is 2+ or more proteinuria
- Persons taking medication for psychiatric illness (excluding cases of intermittent medication due to sleep disorders)
- Those who consumed pro- or prebiotics within 1 month before the screening test
- Those who have taken protein supplements regularly for more than 3 months within 6 months before the screening test
- Those who received other investigational drugs within 1 month before the screening test
- Those who received antibiotics within 2 months before the screening test
- Those who are currently controlling their diet for disease management purposes
- Those with a history of gastrointestinal resection (excluding the appendix)
- Those who are performing or plan to perform regular resistance exercise
- People with vegetarian beliefs
- People with food allergies or restricted foods
- 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)
- Those taking constipation or diarrhea medication
- Those who currently smoke
- Those whose BMI exceeds 30kg/m2 at the time of screening test
- Those who plan to control their weight within 6 months after screening
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06144021