Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults

NCT ID: NCT05828134

Last Updated: 2023-06-15

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2023-01-04

Brief Summary

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To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle strength.

Besides, the investigators use the valued-based healthcare standard set as well as the Center for Epidemiological Studies-Depression, Charlson's comorbidity index Montreal Cognitive Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in validate additional supplement protein-enriched soup plus exercise could improve the vitality and health of mid-aged and old adults.

Detailed Description

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With aging, functions of every organs become to decline. Muscle mass, is one of the decline. According to previous research, adults would lose 40% among from aged 20 to 70. If muscle mass decline combining with the decline of muscle strength is so called Sarcopenia.When muscle mass decline, infectious risk gets higher, and resilience after illness gets lower. In addition, activity and life quality are also responsible for falling, cognitive difficulty, disability and mortality among seniors. We hope to find out the etiologies of Sarcopenia through this program and develop prevention strategy and model to mollify the the negative effect of rapid aging society.

Conditions

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Muscle Loss Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual care group

The control group only performed routine data collection and gave them dietary suggestion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Protein-enriched soup group

Protein-enriched soup /day for use as a supplement with meals and strength training /week

Group Type EXPERIMENTAL

protein-enriched soup

Intervention Type OTHER

The participants in experimental group have a protein-enriched soup a day and do exercise a week

Interventions

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protein-enriched soup

The participants in experimental group have a protein-enriched soup a day and do exercise a week

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. People who aged 50-75 years
2. Patients with following characteristics:
3. feeling loss in activity
4. detecting decline in self's walking speed.
5. feeling tired of doing everything.
6. having fell in last year.
7. People willing to follow the program and cooperate with us for following tracking.
8. People who are neither vegan nor vegetarian
9. People agree and be able to sign the informed consent.
10. the protein of the daily meal are less than 1.0g/kg

Exclusion Criteria

1. People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.
2. People with any disease affecting their limbs, including:
3. having fracture on limbs in the past 6 months
4. having severe arthritis in the past 6 months
5. any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
6. People with intermittent limp caused by peripheral artery diseases
7. People with weak control of mental disorder
8. People with weak control of Cardiopulmonary disease
9. People with weak control of Malignant tumor
10. People with weak control of kidney diseases (eGFR \<60ml/min/1.73)
11. People with Visual impairment and Hearing disorder which cannot help to complete the program.
12. People who have underwent hormone treatment and planned to undergo hormone treatment during program session.
13. Any other condition that PI recognized as not suitable
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laurel Enterprises Corporation

UNKNOWN

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liang-Kung Chen, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Locations

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National Yang Ming Chiao Tung University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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YM109172F

Identifier Type: -

Identifier Source: org_study_id

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