Status:
RECRUITING
Efficacy and Safety of Kefir Whey Postbiotics
Lead Sponsor:
Hanyang University Seoul Hospital
Collaborating Sponsors:
Ottogi Ham Taiho Foundation
Hanyang University
Conditions:
Sarcopenia
Eligibility:
All Genders
40+ years
Phase:
NA
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06144021
Start Date
December 15 2023
End Date
December 31 2024
Last Update
July 10 2024
Active Locations (1)
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1
Hanyang University Medical Center
Seoul, South Korea