Protein-enriched Soup Plus Exercise Improves Muscle Health and Physical Performance

• Sponsor: National Yang Ming University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05828134
• Collaborator: Laurel Enterprises Corporation (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 21.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

To evaluate the effects of protein-enriched soup plus exercise on muscle mass and muscle strength.

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 Assessment , and Mini Nutritional Assessment as outcome measures and to use the trial in validate additional supplement protein-enriched soup plus exercise could improve the vitality and health of mid-aged and old adults.

Condition or Disease	Intervention/Treatment	Phase
Muscle Loss; Muscle Weakness	Other: protein-enriched soup	N/A

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
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Protein-enriched Soup Plus Exercise Improves Muscle Health and Physical Performance: A Randomized Controlled Trial
• Actual Study Start Date: Mar 11, 2021
• Actual Primary Completion Date: Jan 4, 2023
• Actual Study Completion Date: Jan 4, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual care group The control group only performed routine data collection and gave them dietary suggestion.
Experimental: Protein-enriched soup group Protein-enriched soup /day for use as a supplement with meals and strength training /week	Other: protein-enriched soup; The participants in experimental group have a protein-enriched soup a day and do exercise a week

Outcome Measures

Primary Outcome Measures

1. Changes from baseline muscle strength after 12 weeks [baseline, 4, 12 weeks]

   measured by hand grip

2. Changes form baseline QUALITY OF LIFE after 12 weeks [baseline, 4, 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 [baseline, 4, 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 [baseline, 4, 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 [baseline, 4, 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 [baseline, 4, 12 weeks]

   measured by 6-minute walk distance

7. Change from baseline walking speed after 12 weeks [baseline, 4, 12 weeks]

   measured by six-meter walking speed

8. Change from baseline body composition analysis after 12 weeks [baseline, 4, 12 weeks]

   measured by RASM

9. Change from baseline concentration of Total Cholesterol after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of Total Cholesterol after 12 weeks

10. Change from baseline concentration of Triglyceride after 12 weeks [baseline, 4, 12 weeks]

    Change from baseline concentration of Triglyceride after 12 weeks

11. Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks [baseline, 4, 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 [baseline, 4, 12 weeks]

    Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks

13. Change from baseline concentration of dehydroepiandrosterone after 12 weeks [baseline, 4, 12 weeks]

    Change from baseline concentration of dehydroepiandrosterone after 12 weeks

14. Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks [baseline, 4, 12 weeks]

    Change in physical activity measured by IPAQ, indicates that spent being physically active thin the prior 7 days.There are no established thresholds for presenting MET-minutes, the IPAQ Research Committee proposes that reported as comparisons of median values and interquartile ranges for different populations from baseline to 12 weeks in all participants.

Secondary Outcome Measures

1. Change from baseline numbers of Complete blood count after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline numbers of Complete blood count after 12 weeks

2. Change from baseline concentration of Albumin after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of Albumin after 12 weeks

3. Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks [baseline, 4, 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 [baseline, 4, 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 [baseline, 4, 12 weeks]

   Change from baseline concentration of blood urea nitrogen after 12 weeks

6. Change from baseline concentration of Creatinin after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of Creatinin after 12 weeks

7. Change from baseline concentration of Fasting glucose after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of Fasting glucose after 12 weeks

8. Change from baseline concentration of Fasting insulin after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of Fasting insulin after 12 weeks

9. Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks [baseline, 4, 12 weeks]

   Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks

10. Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks [baseline, 4, 12 weeks]

    Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks

11. Change from baseline concentration of Leptin after 12 weeks [baseline, 4, 12 weeks]

    Change from baseline concentration of Leptin after 12 weeks

12. Change from baseline concentration of urine protein after 12 weeks [baseline, 4, 12 weeks]

    Change from baseline concentration of urine protein after 12 weeks

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. People who aged 50-75 years

2. Patients with following characteristics:

3. feeling loss in activity

4. detecting decline in self's walking speed.

5. feeling tired of doing everything.

6. having fell in last year.

7. People willing to follow the program and cooperate with us for following tracking.

8. People who are neither vegan nor vegetarian

9. People agree and be able to sign the informed consent.

10. the protein of the daily meal are less than 1.0g/kg

Exclusion Criteria:

1. People cannot intake provided meals (e.g.: vegans or vegetarians) or any other who is allergic to our diets.

2. People with any disease affecting their limbs, including:

3. having fracture on limbs in the past 6 months

4. having severe arthritis in the past 6 months

5. any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).

6. People with intermittent limp caused by peripheral artery diseases

7. People with weak control of mental disorder

8. People with weak control of Cardiopulmonary disease

9. People with weak control of Malignant tumor

10. People with weak control of kidney diseases (eGFR <60ml/min/1.73)

11. People with Visual impairment and Hearing disorder which cannot help to complete the program.

12. People who have underwent hormone treatment and planned to undergo hormone treatment during program session.

13. Any other condition that PI recognized as not suitable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Yang Ming Chiao Tung University	Taipei		Taiwan

Sponsors and Collaborators

• National Yang Ming University
• Laurel Enterprises Corporation

Investigators

• Principal Investigator: Liang-Kung Chen, MD.PhD., Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Yang Ming University
• ClinicalTrials.gov Identifier: NCT05828134
• Other Study ID Numbers: YM109172F
• First Posted: Apr 25, 2023
• Last Update Posted: Apr 27, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Yang Ming University: Laurel Corporation; Protein-Enriched Soup
• Additional relevant MeSH terms: Muscle Weakness

Study Results

No Results Posted as of Apr 27, 2023