Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults

National Yang Ming Chiao Tung University

Status: Completed

Conditions: Muscle Weakness; Fragility; Muscle Loss

Treatments: Dietary Supplement: 25% protein; Dietary Supplement: 15% protein

Study type: Interventional

Funder types: Other

Identifiers

NCT03784456

19-001-A-2

Details and patient eligibility

About

The subjects of this intervention program are mainly based on community-dwelling mid-aged and older adults. The investigator's program will provide meals containing different proportionated protein.As this project is a double blind test, only the investigators will know which subject corresponding to specific group of diets.

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 Assesment ,and Mini Nutritional Assessment as outcome measures and to use the randomized controlled trial design to validate if increased protein density diet could improve the vitality and health of mid-aged and old adults .

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• People who aged 40-75 years
• Patients with following characteristics:
• feeling loss in activity
• detecting decline in self's walking speed.
• feeling tired of doing everything.
• having fell in last year.
• People can accept undergoing MRI
• People willing to follow the program and cooperate with us for following tracking.
• People who are neither vegan nor vegetarian
• People agree and be able to sign the informed consent.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

25% protein group

Experimental group

Description:

This experimental arm will be given meals containing 25% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.

Treatment:

Dietary Supplement: 25% protein

15% protein group

Active Comparator group

Description:

This control arm will be given meals containing 15% protein under same estimated calorie menus and protein may come from either egg, meat, fish, soy, or milk product. The meals would be provided 2 times per day, 5 days per week. The program will last for 12 weeks.

Treatment:

Dietary Supplement: 15% protein