Status:
COMPLETED
Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Collaborating Sponsors:
Laurel Corporation, Taiwan
Conditions:
Sarcopenia
Muscle Loss
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The study is a 12-week randomized controlled trial designed to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance a...
Detailed Description
As age increases, the muscle mass of the individual will gradually decrease, which will affect muscle strength and function. If the condition continues to deteriorate, the individual may develop a syn...
Eligibility Criteria
Inclusion
- People aged 65 years or older
- People with nutritional risk: Mini Nutritional Assessment (MNA) is less than or equal to eleven points.
- People with risk of sarcopenia: SARC-F questionnaire greater than or equal to four points or SARC-CalF questionnaire greater than or equal to eleven points.
- People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the following tracking.
Exclusion
- People that are unable to cooperate with or accept lacto-vegetarian-based/nuts/gluten foods, such as those who are allergic to dietary content, nuts or gluten, etc.
- According to the PI's judgment, people with severe or poorly controlled conditions include acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.
- People with liver cirrhosis
- People with chronic kidney diseases (eGFR \<30ml/min/1.73m2)
- People with severe visual or hearing impairment that prevent the completion of assessment and testing
- People with malignant tumors that have just been diagnosed or are undergoing treatment or are still at risk of recurrence
- People are known to be infected with human immunodeficiency virus or HIV antibody-positive.
- People have received hormone therapy within three months before the trial or are expected to receive hormone therapy during the trial
- People are currently or expected to join any other physical training courses or nutrition plans during the trial
- Others are based on the judgment of the PI that participating in this trial may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the trial.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05243472
Start Date
March 1 2022
End Date
August 31 2023
Last Update
August 7 2024
Active Locations (1)
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1
Buddhist Tzu Chi General Hospital
Hualien City, Taiwan, 97071