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

NCT03784456 | Completed

• 1 other identifier: 19-001-A-2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Muscle Loss; Muscle Weakness; Fragility

Outcome Measures

Primary Outcomes (8)

• Changes from baseline muscle strength after 12 weeks

  measured by hand grip

  baseline,12 weeks

• Changes form baseline QUALITY OF LIFE after 12 weeks

  measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition

  baseline, 12 weeks

• Change from baseline Nutrition intake after 12 weeks

  measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

  baseline, 12 weeks.

• Change from baseline depression after 12 weeks

  measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

  baseline,12 weeks

• Change from baseline cognitive ability after 12 weeks

  measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition

  baseline, 12 weeks

• Change from baseline endurance after 12 weeks

  measured by 6-minute walk distance

  baseline, 12 weeks

• Change from baseline walking speed after 12 weeks

  measured by six-meter walking speed

  baseline, 12 weeks

• Change from baseline timed up and go test after 12 weeks

  measured by timed up and go test (TUG) and six-meter walking speed

  baseline, 12 weeks

Secondary Outcomes (17)

• Change from baseline numbers of Complete blood count after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of Albumin after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks

  baseline,12 weeks

• Change from baseline concentration of blood urea nitrogen after 12 weeks

  baseline,12 weeks

Study Arms (2)

25% protein group

EXPERIMENTAL

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.

Dietary Supplement: 25% protein

15% protein group

ACTIVE COMPARATOR

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.

Dietary Supplement: 15% protein

Interventions

25% protein DIETARY_SUPPLEMENT

Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.

25% protein group

15% protein DIETARY_SUPPLEMENT

Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.

15% protein group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead
• Laurel Corporation, Taiwan: collaborator

Study Sites (1)

National Yang Ming University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Muscular Atrophy; Muscle Weakness

Interventions

Proteins

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Liang-Kung Chen, MD.PhD.

  Aging and Health Research Center, National Yang Ming University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The program is designed as a double blind test, randomized intervention. Which meant that neither the subjects nor the PI and co-PI would not know which kind of diet they're going to obtain. Only investigators and test provider would know the meals corresponding to respective groups of subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 24, 2018
• Study Start: February 13, 2019
• Primary Completion: July 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

TW (1)