NCT05828134

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 4, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
Last Updated

June 15, 2023

Status Verified

April 1, 2023

Enrollment Period

1.8 years

First QC Date

April 13, 2023

Last Update Submit

June 13, 2023

Conditions

Muscle LossMuscle Weakness

Keywords

Laurel CorporationProtein-Enriched Soup

Outcome Measures

Primary Outcomes (1)

  • Changes from baseline physical function after 12 weeks

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

    baseline, 4, 12 weeks

Secondary Outcomes (23)

  • Change from baseline numbers of Complete blood count after 12 weeks

    baseline, 4, 12 weeks

  • Change from baseline concentration of Albumin after 12 weeks

    baseline, 4, 12 weeks

  • Change from baseline concentration of Alanine Aminotransferase (ALT) after 12 weeks

    baseline, 4, 12 weeks

  • Change from baseline concentration of Aspartate Aminotransferase (AST) after 12 weeks

    baseline, 4, 12 weeks

  • Change from baseline concentration of blood urea nitrogen after 12 weeks

    baseline, 4, 12 weeks

  • +18 more secondary outcomes

Study Arms (2)

Usual care group

NO INTERVENTION

The control group only performed routine data collection and gave them dietary suggestion.

Protein-enriched soup group

EXPERIMENTAL

Protein-enriched soup /day for use as a supplement with meals and strength training /week

Other: protein-enriched soup

Interventions

protein-enriched soupOTHER

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

Protein-enriched soup group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, Taiwan

Location

MeSH Terms

Conditions

Muscular AtrophyMuscle Weakness

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsMuscular DiseasesMusculoskeletal DiseasesPathologic Processes

Study Officials

  • Liang-Kung Chen, MD.PhD.

    Center for Healthy Longevity and Aging Sciences, National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2023

First Posted

April 25, 2023

Study Start

March 11, 2021

Primary Completion

January 4, 2023

Study Completion

January 4, 2023

Last Updated

June 15, 2023

Record last verified: 2023-04

Locations

TW(1)