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Completed

NCT Number: NCT05828134

Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults

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.

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Key information

Conditions

Muscle Loss Atrophy Muscle Weakness Muscular Atrophy Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People who aged 50-75 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 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.
  • the protein of the daily meal are less than 1.0g/kg

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 have underwent hormone treatment and planned to undergo hormone treatment during program session.
  • Any other condition that PI recognized as not suitable

Treatment and study plan

protein-enriched soup

Other

The participants in experimental group have a protein-enriched soup a day and do exercise a week

Primary outcomes

  1. Changes from baseline physical function after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by hand grip, 6-minute walk distance, six-meter walking speed, 5 times sit-to-stand

Secondary outcomes

  1. Change from baseline numbers of Complete blood count after 12 weeks

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: baseline, 4, 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, 4, 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, 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

    Time frame: 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

    Time frame: 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

    Time frame: baseline, 4, 12 weeks

    Change from baseline concentration of Leptin after 12 weeks

  12. Change from baseline concentration of urine protein after 12 weeks

    Time frame: baseline, 4, 12 weeks

    Change from baseline concentration of urine protein after 12 weeks

  13. Changes form baseline QUALITY OF LIFE after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by the 36-Item Short Form Health Survey (SF-36), ranged 0-100, higher values represent a better condition

  14. Change from baseline Nutrition intake after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition

  15. Change from baseline depression after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition

  16. Change from baseline cognitive ability after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by Montreal Cognitive Assessment (MoCA) , ranged 0-30, higher values represent a better condition

  17. Change from baseline body composition analysis after 12 weeks

    Time frame: baseline, 4, 12 weeks

    measured by RASM

  18. Change from baseline concentration of Total Cholesterol after 12 weeks

    Time frame: baseline, 4, 12 weeks

    Change from baseline concentration of Total Cholesterol after 12 weeks

  19. Change from baseline concentration of Triglyceride after 12 weeks

    Time frame: baseline, 4, 12 weeks

    Change from baseline concentration of Triglyceride after 12 weeks

  20. Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks

    Time frame: baseline, 4, 12 weeks

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

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

    Time frame: baseline, 4, 12 weeks

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

  22. Change from baseline concentration of dehydroepiandrosterone after 12 weeks

    Time frame: baseline, 4, 12 weeks

    Change from baseline concentration of dehydroepiandrosterone after 12 weeks

  23. Change in International Physical Activity Questionnaire (IPAQ) after 12 weeks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Collaborators

  • Laurel Enterprises Corporation

Registry information

Official study title

Enhancing Muscle Health and Metabolism in Pre-frail Middle-aged and Older Adults: A Randomized Controlled Trial Investigating the Benefits of Protein-enriched Supplementation and Weekly Exercise

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2023
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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