Actively Recruiting
Efficacy and Safety of Kefir Whey Postbiotics
Led by Hanyang University Seoul Hospital · Updated on 2024-07-10
60
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
H
Hanyang University Seoul Hospital
Lead Sponsor
O
Ottogi Ham Taiho Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Kefir Whey Postbiotics
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 40 years or older at screening
- Charlson Comorbidity Index (CCI) score of 0 at screening
- Skeletal muscle mass less than 110% of the standard measured by bioelectrical impedance analysis at screening
You will not qualify if you...
- Significant hypersensitivity to melon gourd, whey, or lactic acid bacteria ingredients
- Participation in other human studies, diet, or exercise programs within 3 months before screening
- Clinically significant acute or chronic cardiovascular, diabetes, endocrine, immune, respiratory, hepatobiliary, renal, neuropsychiatric, or gastrointestinal diseases requiring treatment
- Blood or urine test results showing AST or ALT > 1.5 times the upper limit, serum creatinine > 1.4 mg/dL, or fasting blood sugar > 126 mg/dL
- Proteinuria of 2+ or more
- Taking medication for psychiatric illness (except intermittent sleep disorder medication)
- Consumption of pro- or prebiotics within 1 month before screening
- Regular use of protein supplements for more than 3 months within 6 months before screening
- Use of investigational drugs within 1 month before screening
- Use of antibiotics within 2 months before screening
- Currently controlling diet for disease management
- History of gastrointestinal resection (excluding appendix)
- Performing or planning regular resistance exercise
- Vegetarian beliefs
- Food allergies or restricted foods
- History of diagnosed gastrointestinal diseases such as ulcerative colitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiac disease, short bowel, or ileostomy
- Use of constipation or diarrhea medication
- Current smoking
- Body mass index (BMI) over 30 kg/m2 at screening
- Planning weight control within 6 months after screening
- Likely to be uncooperative or unable to proceed with the test as determined by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hanyang University Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jun Yup Kim, MD, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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