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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03784456
• Other study ID #: 19-001-A-2
• Status: Completed
• Phase: N/A
• Start date: February 13, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fragility
• Muscle Loss
• Muscle Weakness

Intervention

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.
• 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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming University	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Laurel Corporation, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline muscle strength after 12 weeks	measured by hand grip	baseline,12 weeks
Primary	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
Primary	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.
Primary	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
Primary	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
Primary	Change from baseline endurance after 12 weeks	measured by 6-minute walk distance	baseline, 12 weeks
Primary	Change from baseline walking speed after 12 weeks	measured by six-meter walking speed	baseline, 12 weeks
Primary	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	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
Secondary	Change from baseline concentration of Albumin after 12 weeks	Change from baseline concentration of Albumin after 12 weeks	baseline,12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline concentration of Creatinin after 12 weeks	Change from baseline concentration of Creatinin after 12 weeks	baseline,12 weeks
Secondary	Change from baseline concentration of Fasting glucose after 12 weeks	Change from baseline concentration of Fasting glucose after 12 weeks	baseline,12 weeks
Secondary	Change from baseline concentration of Fasting insulin after 12 weeks	Change from baseline concentration of Fasting insulin after 12 weeks	baseline,12 weeks
Secondary	Change from baseline concentration of Total Cholesterol after 12 weeks	Change from baseline concentration of Total Cholesterol after 12 weeks	baseline,12 weeks
Secondary	Change from baseline concentration of Triglyceride after 12 weeks	Change from baseline concentration of Triglyceride after 12 weeks	baseline,12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline concentration of dehydroepiandrosterone after 12 weeks	Change from baseline concentration of dehydroepiandrosterone after 12 weeks	baseline,12 weeks
Secondary	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
Secondary	Change from baseline concentration of Leptin after 12 weeks	Change from baseline concentration of Leptin after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of urine protein after 12 weeks	Change from baseline concentration of urine routine after 12 weeks	baseline, 12 weeks