Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-24

Study Completion Date

2023-06-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Low Muscle Mass Low Muscle Strength Low Physical Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Protein Supplementation Group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

1. Willing to provide written informed consent.
2. 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.
3. Adults aged 60 years or older, male or female.
4. Able to ambulate independently.
5. 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

Exclusion Criteria

1. Impaired renal function.
2. Allergy or intolerance to protein supplements.
3. Currently undergoing cancer treatment.
4. Autoimmune diseases.
5. Assessed by a physician as unsuitable to participate.

Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes