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

• ClinicalTrials.gov Identifier: NCT03784456
• Recruitment Status: Completed
• First Posted: December 24, 2018
• Last Update Posted: February 27, 2020
• Sponsor: National Yang Ming University
• Collaborator: Laurel Corporation, Taiwan
• Information provided by (Responsible Party): National Yang Ming University

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 .

Condition or disease	Intervention/treatment	Phase
Muscle Loss; Muscle Weakness; Fragility	Dietary Supplement: 25% protein; Dietary Supplement: 15% protein	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This program is designed as a double blind parallel randomized intervention. The primary purpose of this program is Prevention.
• Masking: Single (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.
• Primary Purpose: Prevention
• Official Title: Impact of Increased Protein Density Diet to Muscle Mass and Strength Among Mid-aged and Older Adults
• Actual Study Start Date: February 13, 2019
• Actual Primary Completion Date: July 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Changes from baseline muscle strength after 12 weeks [ Time Frame: baseline,12 weeks ]
   measured by hand grip
2. Changes form baseline QUALITY OF LIFE after 12 weeks [ Time Frame: baseline, 12 weeks ]
   measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition
3. Change from baseline Nutrition intake after 12 weeks [ Time Frame: baseline, 12 weeks. ]
   measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition
4. Change from baseline depression after 12 weeks [ Time Frame: baseline,12 weeks ]
   measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition
5. Change from baseline cognitive ability after 12 weeks [ Time Frame: baseline, 12 weeks ]
   measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition
6. Change from baseline endurance after 12 weeks [ Time Frame: baseline, 12 weeks ]
   measured by 6-minute walk distance
7. Change from baseline walking speed after 12 weeks [ Time Frame: baseline, 12 weeks ]
   measured by six-meter walking speed
8. Change from baseline timed up and go test after 12 weeks [ Time Frame: baseline, 12 weeks ]
   measured by timed up and go test (TUG) and six-meter walking speed

Secondary Outcome Measures :

1. Change from baseline numbers of Complete blood count after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline numbers of Complete blood count after 12 weeks
2. Change from baseline concentration of Albumin after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Albumin after 12 weeks
3. Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks
4. Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks
5. Change from baseline concentration of blood urea nitrogen after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of blood urea nitrogen after 12 weeks
6. Change from baseline concentration of Creatinin after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Creatinin after 12 weeks
7. Change from baseline concentration of Fasting glucose after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Fasting glucose after 12 weeks
8. Change from baseline concentration of Fasting insulin after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Fasting insulin after 12 weeks
9. Change from baseline concentration of Total Cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
   Change from baseline concentration of Total Cholesterol after 12 weeks
10. Change from baseline concentration of Triglyceride after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of Triglyceride after 12 weeks
11. Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks
12. Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks
13. Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks
14. Change from baseline concentration of dehydroepiandrosterone after 12 weeks [ Time Frame: baseline,12 weeks ]
    Change from baseline concentration of dehydroepiandrosterone after 12 weeks
15. Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks [ Time Frame: baseline, 12 weeks ]
    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks
16. Change from baseline concentration of Leptin after 12 weeks [ Time Frame: baseline, 12 weeks ]
    Change from baseline concentration of Leptin after 12 weeks
17. Change from baseline concentration of urine protein after 12 weeks [ Time Frame: baseline, 12 weeks ]
    Change from baseline concentration of urine routine after 12 weeks

Eligibility Criteria

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

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

Contacts and Locations

Locations

Taiwan

National Yang Ming University

Taipei, Taiwan, 112

Sponsors and Collaborators

National Yang Ming University

Laurel Corporation, Taiwan

Investigators

• Principal Investigator: Liang-Kung Chen, MD.PhD.; Aging and Health Research Center, National Yang Ming University

More Information

• Responsible Party: National Yang Ming University
• ClinicalTrials.gov Identifier: NCT03784456
• Other Study ID Numbers: 19-001-A-2
• First Posted: December 24, 2018
• Last Update Posted: February 27, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Muscle Weakness; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes