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

Primary Purpose

Muscle Loss, Muscle Weakness, Fragility

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
25% protein
15% protein
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Loss

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Yang Ming University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

25% protein group

15% protein group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Changes from baseline muscle strength after 12 weeks
measured by hand grip
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
Change from baseline Nutrition intake after 12 weeks
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
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
Change from baseline cognitive ability after 12 weeks
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Change from baseline endurance after 12 weeks
measured by 6-minute walk distance
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Change from baseline timed up and go test after 12 weeks
measured by timed up and go test (TUG) and six-meter walking speed

Secondary Outcome Measures

Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline numbers of Complete blood count after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Albumin after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of blood urea nitrogen after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Creatinin after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting glucose after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of Fasting insulin after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Total Cholesterol after 12 weeks
Change from baseline concentration of Triglyceride after 12 weeks
Change from baseline concentration of Triglyceride after 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
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol after 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
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Change from baseline concentration of dehydroepiandrosterone after 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
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of Leptin after 12 weeks
Change from baseline concentration of urine protein after 12 weeks
Change from baseline concentration of urine routine after 12 weeks

Full Information

First Posted
December 6, 2018
Last Updated
February 25, 2020
Sponsor
National Yang Ming University
Collaborators
Laurel Corporation, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03784456
Brief Title
Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
Official Title
Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
Collaborators
Laurel Corporation, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Loss, Muscle Weakness, Fragility

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25% protein group
Arm Type
Experimental
Arm 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.
Arm Title
15% protein group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
25% protein
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
15% protein
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline muscle strength after 12 weeks
Description
measured by hand grip
Time Frame
baseline,12 weeks
Title
Changes form baseline QUALITY OF LIFE after 12 weeks
Description
measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition
Time Frame
baseline, 12 weeks
Title
Change from baseline Nutrition intake after 12 weeks
Description
measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
Time Frame
baseline, 12 weeks.
Title
Change from baseline depression after 12 weeks
Description
measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
Time Frame
baseline,12 weeks
Title
Change from baseline cognitive ability after 12 weeks
Description
measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
Time Frame
baseline, 12 weeks
Title
Change from baseline endurance after 12 weeks
Description
measured by 6-minute walk distance
Time Frame
baseline, 12 weeks
Title
Change from baseline walking speed after 12 weeks
Description
measured by six-meter walking speed
Time Frame
baseline, 12 weeks
Title
Change from baseline timed up and go test after 12 weeks
Description
measured by timed up and go test (TUG) and six-meter walking speed
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline numbers of Complete blood count after 12 weeks
Description
Change from baseline numbers of Complete blood count after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Albumin after 12 weeks
Description
Change from baseline concentration of Albumin after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Description
Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Description
Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of blood urea nitrogen after 12 weeks
Description
Change from baseline concentration of blood urea nitrogen after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Creatinin after 12 weeks
Description
Change from baseline concentration of Creatinin after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Fasting glucose after 12 weeks
Description
Change from baseline concentration of Fasting glucose after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Fasting insulin after 12 weeks
Description
Change from baseline concentration of Fasting insulin after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Total Cholesterol after 12 weeks
Description
Change from baseline concentration of Total Cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of Triglyceride after 12 weeks
Description
Change from baseline concentration of Triglyceride after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Description
Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Description
Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Description
Change from baseline concentration of dehydroepiandrosterone after 12 weeks
Time Frame
baseline,12 weeks
Title
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Description
Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of Leptin after 12 weeks
Description
Change from baseline concentration of Leptin after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of urine protein after 12 weeks
Description
Change from baseline concentration of urine routine after 12 weeks
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Kung Chen, MD.PhD.
Organizational Affiliation
Aging and Health Research Center, National Yang Ming University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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