Efficacy and Safety of Kefir Whey Postbiotics

NCT06230302 | Enrolling By Invitation

• 1 other identifier: HYUH 2023-07-059-009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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. 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

Sarcopenia

Outcome Measures

Primary Outcomes (2)

• Grip strength test for both hands

  Handgrip strength should be measured using the JAMAR grip dynamometer (Jamar, Plus+ Digital Hand Dynamometer, Preferred, USA). While the research subject is sitting, the grip strength of both hands is measured three times each, and the average value is taken as the representative value. The unit of grip strength is kg.

  1) Day 0, 2) end of 12 weeks

• Dual energy xray absorptiometry

  Dexa imaging measures the whole body, lean mass, body fat mass, bone mineral content, and height using Hanyang University Hospital's DXA (Discovery W DEXA) equipment after fasting for more than 8 hours. Measurements will be taken with the study subject standing upright, rotating both feet inward about 15 degrees, and placing both hands next to the waist. Here, the investigators will measure skeletal muscle mass (SMM, kg) by subtracting bone mineral content from lean body mass. And the SMM (kg) and the height (m) will be combined to report skeletal muscle mass index (SMMI) in kg/m\^2 unit.

  Time Frame: 1) Day 0, 2) end of 12 weeks

Secondary Outcomes (2)

• Biomarkers from blood

  Time Frame: 1) Day 0, 2) end of 12 weeks

• Confirmation of intestinal microorganisms

  Time Frame: 1) Day 0, 2) end of 12 weeks

Study Arms (2)

Kefir Postbiotics Group

EXPERIMENTAL

* 30 healthy adult participants * Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor * Period of use: 12 months * Storage method: Store at room temperature * Manufacturing method: The whey postbiotics derived from kefir lactic acid bacteria used in the test food are produced in the laboratory at Hanyang University, and additional ingredients are purchased from finished products. Laboratory collects the ingredients and delivers them to the manufacturer, Neo Natural, to manufacture them so that there are no differences in properties and formulations.

Dietary Supplement: Whey postbiotics derived from kefir lactic acid bacteria

Control Group

PLACEBO COMPARATOR

* 30 healthy adult participants * Appearance and formulation: Yellow powder/capsule with unique flavor and no off-flavor * Period of use: 12 months * Storage method: Store at room temperature * Manufacturing method: The same product without whey postbiotics.

Dietary Supplement: Placebo powder

Interventions

Whey postbiotics derived from kefir lactic acid bacteria DIETARY_SUPPLEMENT

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

Kefir Postbiotics Group

Placebo powder DIETARY_SUPPLEMENT

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

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University: lead
• Hanyang University Seoul Hospital: collaborator

Study Sites (1)

Hanyang University

Seoul, South Korea

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jun Yup Kim, MD,MS

  Hanyang University Seoul Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the trial period, neither the researcher nor the research subjects know the randomization information of the research subjects. In principle, the randomization code is maintained and stored by the researcher. In general, double blinding should not be lifted until all research subjects have completed the test and the data is locked. However, in the case of an emergency such as a health problem of a research subject during intervention, double blinding may be lifted at the discretion of the researcher. In this case, the research person must contact the principal investigator as quickly as possible. The date, time, and reason for lifting double blinding must be documented in an appropriate location in the case record and supporting documents. A copy of the double-blind code release confirmation document received from the principal investigator must be kept in the supporting documents.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind randomized controlled trial

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 30, 2024
• Study Start: December 26, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)