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

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 .

Study Overview

• Status: Completed
• Conditions: Muscle Weakness; Muscle Loss; Fragility
• Intervention / Treatment: Dietary supplement: 25% protein; Dietary supplement: 15% protein

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • National Yang Ming University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 25% protein group; 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; 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.
Active Comparator: 15% protein group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline numbers of Complete blood count after 12 weeks	Change from baseline numbers of Complete blood count after 12 weeks	baseline,12 weeks
Change from baseline concentration of Albumin after 12 weeks	Change from baseline concentration of Albumin after 12 weeks	baseline,12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks	Change from baseline concentration of blood urea nitrogen after 12 weeks	baseline,12 weeks
Change from baseline concentration of Creatinin after 12 weeks	Change from baseline concentration of Creatinin after 12 weeks	baseline,12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks	Change from baseline concentration of Fasting glucose after 12 weeks	baseline,12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks	Change from baseline concentration of Total Cholesterol after 12 weeks	baseline,12 weeks
Change from baseline concentration of Triglyceride after 12 weeks	Change from baseline concentration of Triglyceride after 12 weeks	baseline,12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks	Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks	baseline,12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks	Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks	baseline,12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks	Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks	baseline,12 weeks
Change from baseline concentration of dehydroepiandrosterone after 12 weeks	Change from baseline concentration of dehydroepiandrosterone after 12 weeks	baseline,12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 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	Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks	baseline,12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks	Change from baseline concentration of Fasting insulin after 12 weeks	baseline,12 weeks
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks	Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks	baseline, 12 weeks
Change from baseline concentration of Leptin after 12 weeks	Change from baseline concentration of Leptin after 12 weeks	baseline, 12 weeks
Change from baseline concentration of urine protein after 12 weeks	Change from baseline concentration of urine routine after 12 weeks	baseline, 12 weeks

Collaborators and Investigators

• Sponsor: National Yang Ming University
• Collaborators: Laurel Corporation, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness
• Other Study ID Numbers: 19-001-A-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No