Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

NCT07309120 | Completed

• 1 other identifier: 202100551A3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.

Conditions

Low Muscle Strength; Low Physical Function; Low Muscle Mass

Keywords

metabolomics; supplemenation; pre-sarcopenia

Outcome Measures

Primary Outcomes (3)

• Appendicular Skeletal Muscle Index (ASMI)

  Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).

  Baseline and 12 weeks after intervention

• Handgrip Strength (HGS)

  Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.

  Baseline and 12 weeks after intervention

• Gait speed (m/s)

  Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).

  Baseline and 12 weeks after intervention

Study Arms (1)

Protein Supplementation Group

EXPERIMENTAL

Dietary Supplement: Participants consume two sachets daily over a 12-week intervention period.

Interventions

Participants consume two sachets daily over a 12-week intervention period. DIETARY_SUPPLEMENT

Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates.

Protein Supplementation Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide written informed consent.
• Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.
• Adults aged 60 years or older, male or female.
• Able to ambulate independently.
• Meets at least one of the following sarcopenia criteria:
• Grip strength: Men \< 28 kg; Women \< 18 kg Gait speed: \< 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men \< 7.0 kg/m²; Women \< 5.7 kg/m²

You may not qualify if:

• Impaired renal function.
• Allergy or intolerance to protein supplements.
• Currently undergoing cancer treatment.
• Autoimmune diseases.
• Assessed by a physician as unsuitable to participate.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Guishan, 333, Taiwan

Location

Related Publications (2)

• Prado CM, Landi F, Chew STH, Atherton PJ, Molinger J, Ruck T, Gonzalez MC. Advances in muscle health and nutrition: A toolkit for healthcare professionals. Clin Nutr. 2022 Oct;41(10):2244-2263. doi: 10.1016/j.clnu.2022.07.041. Epub 2022 Aug 7.

  PMID: 36081299 BACKGROUND

• Lee SY, Lee HJ, Lim JY. Effects of leucine-rich protein supplements in older adults with sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104758. doi: 10.1016/j.archger.2022.104758. Epub 2022 Jun 24.

  PMID: 35777246 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 30, 2025
• Study Start: December 24, 2021
• Primary Completion: May 31, 2023
• Study Completion: June 20, 2023
• Last Updated: January 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)