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Evaluation of the Effects of Rice Germ Extract-Enriched Functional Food on Muscle Strength in Middle-aged and Older Adults.

Efficacy Study of Functional Foods Containing Rice Germ Extract-Based Complex for Muscle Strength Improvement in Middle-aged and Elderly Subjects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010503
Enrollment
50
Registered
2025-05-22
Start date
2024-10-28
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Intervention Group (Experimental): Participants in the intervention group consumed a functional food containing rice germ extract at a dose of 3 g once daily for a period of 3 mon

Sponsors

Kyung Hee University Global Campus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Individuals aged between 50 and 79 years. ? Individuals whose handgrip strength in both hands falls below the standard reference values for their respective age and sex: 1) Age 50–59: = 42.0 kg for men, = 25.1 kg for women 2) Age 60–69: = 38.5 kg for men, = 24.1 kg for women 3) Age 70–79: = 33.2 kg for men, = 20.9 kg for women ? Individuals capable of performing normal physical activities and who have provided written informed consent to participate in the study. ? Individuals who are capable of oral intake.

Exclusion criteria

Exclusion criteria: ? Individuals whose handgrip strength exceeds the age-specific reference range. ? Individuals whose handgrip strength is below 28 kg for men or below 18 kg for women in both hands. ? Individuals with a BMI of 30 kg/m² or higher. ? Individuals who have musculoskeletal disorders (e.g., history of orthopedic surgery, current treatment for arthritis, or hip fractures), spinal disorders (e.g., spondylitis, ankylosing conditions), cognitive impairment (e.g., dementia, mild cognitive impairment), or neurological diseases (e.g., neuritis, stroke, cerebral hemorrhage) that hinder regular walking, daily activities, or exercise. ? Individuals currently taking psychiatric medications due to a diagnosed mental disorder. (However, those with insomnia receiving intermittent treatment or with adequately managed depression may participate at the discretion of the investigator.) ? Individuals with gastrointestinal disorders that may interfere with the consumption of the test product. ? Individuals with dietary restrictions due to diabetes, renal diseases (e.g., renal failure, dialysis), or hepatic diseases (e.g., cirrhosis, liver cancer), or those currently undergoing cancer treatment (e.g., surgery, chemotherapy, or radiation therapy). ? Individuals who have taken systemic corticosteroids (e.g., cortisol) or hormone therapies (e.g., testosterone, estrogen, androgen, growth hormone, or adrenal cortex hormones) within 4 weeks prior to the first visit. ? Individuals who have taken muscle-strength-related supplements (e.g., amino acids, creatine) or health functional foods associated with muscle strength improvement (e.g., calcium, vitamin D), or probiotics (more than 4 times per week) within 2 weeks prior to the first visit. (Participants taking calcium or vitamin D for more than 3 months without dosage change may be included.) ? Individuals with a history of alcohol abuse or those who chronically consume alcohol. * Defined as average daily alcohol intake exceeding 40 g (280 g/week) for men, or 20 g (140 g/week) for women. ? Individuals who have participated in other interventional clinical trials (including human studies) within 2 months prior to the first visit or who plan to participate in other interventional clinical trials during the study period. ? Individuals who are allergic or sensitive to any component of the investigational product (test or placebo). ? Individuals deemed inappropriate for participation by the investigator for other reasons (e.g., those who may cause disruption in the study environment).

Design outcomes

Primary

MeasureTime frame
Change in handgrip strength

Secondary

MeasureTime frame
Change in isokinetic muscle strength

Countries

Korea, Republic of

Contacts

Public ContactHee-Sook Lim

Kyung Hee University Global Campus

limhsgeron@khu.ac.kr+82-31-201-2936

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026