Effect of Kefir Whey Postbiotics on Muscle Strength in Older Adults

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

This study is testing if a special drink made from kefir can help older adults build muscle strength and improve their gut health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Hanyang University Seoul Hospital (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06144021 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of whey postbiotics derived from kefir lactic acid bacteria in improving muscle strength and intestinal microbiome in elderly individuals. Participants aged 40 and older will be randomly assigned to receive either the kefir-derived postbiotics or a placebo for 12 weeks, with evaluations including grip strength tests and dual energy x-ray absorptiometry (DXA) to assess muscle strength. The study aims to analyze changes in the intestinal microbiome through fecal collection and next-generation sequencing. Follow-up visits will occur at Hanyang University Hospital to monitor progress and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 years or older with low skeletal muscle mass and no significant comorbidities.

Not a fit: Patients with significant hypersensitivity to whey or lactic acid bacteria, or those with serious chronic diseases, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel dietary intervention to enhance muscle strength and gut health in older adults, potentially reducing the risk of sarcopenia.

How similar studies have performed: Previous studies have shown promising results with similar probiotic approaches, suggesting potential for success in this novel application.

Eligibility criteria

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

Where this trial is running

Seoul

• Hanyang University Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Jun Yup Kim, MD, MS

Conditions: Sarcopenia