Efficacy and Safety of Protein Product in Volunteers With Sarcopenia
1 other identifier
interventional
45
0 countries
N/A
Brief Summary
The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
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
First Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
May 22, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 20, 2024
CompletedMay 24, 2023
May 1, 2023
8 months
May 11, 2023
May 22, 2023
Conditions
Outcome Measures
Primary Outcomes (6)
Muscle strength
Using handgrip strength instrument (high value means high strength)
12 weeks
Muscle mass
Using Bioelectrical Impedance Analysis instrument (high value means high mass)
12 weeks
Physical performance
Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance.
12 weeks
Sarcopenia score
Sarcopenia questionnaires (score 1 to 10 means low severity to high severity)
12 weeks
Body weight
Body weight of the patients
12 weeks
Body mass index
Body mass index of the patients
12 weeks
Secondary Outcomes (17)
Nutritional status
12 weeks
Hungry feeling
12 weeks
Quality of life of the patient
12 weeks
Concentration of total protein in serum
12 weeks
Concentration of immunoglobulin in serum
12 weeks
- +12 more secondary outcomes
Study Arms (3)
whey protein isolate group
EXPERIMENTALWhey protein isolate is contained in the sachet.
isolated soy protein group
EXPERIMENTALIsolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet.
placebo group
EXPERIMENTALBase powder without proteins is contained in the sachet
Interventions
Eligibility Criteria
You may qualify if:
- Age more than 20 years
- Sarcopenia score more than 4
- Handgrip strength less than 28 kg in male and less than 18 kg in female and muscle mass less than 7 kg/m2 in male and less than 5.7 kg/m2 in female or Gait speed (6-meter walk) less than 1 m/s
- Can take protein from animal
- Can read and write or have people to look after
- Willing to participate in this study
You may not qualify if:
- Allergic to protein from animals and plants
- Hepatitis or cirrhosis
- Glomerular disease or glomerular filtration rate less than 60 ml/min/1.73m2
- Cancer or heart disease
- Cannot walk
- Pregnancy and lactation
- Duodenal surgery
- Take protein supplement within 2 weeks
- Take protein in normal food more than 1.2 g/body weight/day
- Participating in other studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2023
First Posted
May 22, 2023
Study Start
June 1, 2023
Primary Completion
February 1, 2024
Study Completion
March 20, 2024
Last Updated
May 24, 2023
Record last verified: 2023-05