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Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults

Primary Purpose

Sarcopenia, Muscle Loss, Malnutrition

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Protein nutritional supplement
Sponsored by
Buddhist Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sarcopenia focused on measuring Older adults, Sarcopenia, Malnutrition

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Sites / Locations

  • Buddhist Tzu Chi General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Protein nutritional supplement group

Arm Description

Participants in the control group will not receive any intervention during the study period.

Participants in the intervention group will receive protein-enriched soups (24-30g of protein) per day for 12 weeks. Protein may come from either soy, bean or milk products.

Outcomes

Primary Outcome Measures

Changes from baseline muscle strength measure by hand grip strength after 12 weeks
measured by hand grip strength
Change from baseline walking speed after 12 weeks
measured by six-meter walking speed
Changes from baseline physical performance after 12 weeks
measured by Short Physical Performance Battery
Changes from baseline frailty after 12 weeks
measured by Clinical Frailty Scale
Changes from baseline frail status after 12 weeks
measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale
Changes from baseline cognition after 12 weeks
measured by Mini-Mental Status Examination
Changes from baseline depression after 12 weeks
measured by Geriatric Depression Scale
Changes from baseline quality of life after 12 weeks
measured by WHOQOL-BREF (Taiwan Version)
Changes from baseline physical activity after 12 weeks
measured by the International Physical Activity Questionnaire (IPAQ)
Changes from baseline nutritional status after 12 weeks
measured by Mini-Nutritional Assessment-Short Form (MNA-SF)
Changes from baseline dietary assessment after 12 weeks
measured by Food Frequency Questionnaires (FFQ)

Secondary Outcome Measures

Change from baseline complete blood count 12 weeks
Change from baseline complete blood count 12 weeks
Change from baseline differential count 12 weeks
Change from baseline differential count 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks
Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks
Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks
Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Change from baseline concentration of sodium after 12 weeks
Change from baseline concentration of sodium after 12 weeks
Change from baseline concentration of potassium after 12 weeks
Change from baseline concentration of potassium after 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Change from baseline concentration of total protein after 12 weeks
Change from baseline concentration of total protein after 12 weeks
Change from baseline concentration of albumin after 12 weeks
Change from baseline concentration of albumin after 12 weeks
Change from baseline concentration of globulin after 12 weeks
Change from baseline concentration of globulin after 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Change from baseline concentration of triglyceride after 12 weeks
Change from baseline concentration of triglyceride after 12 weeks
Change from baseline concentration of fasting glucose after 12 weeks
Change from baseline concentration of fasting glucose after 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Change from baseline concentration of fasting insulin after 12 weeks
Change from baseline concentration of fasting insulin after 12 weeks
Change from baseline concentration of Vitamin D after 12 weeks
Change from baseline concentration of Vitamin D after 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Change from baseline body weight after 12 weeks
Change from baseline body weight after 12 weeks
Change from baseline fat mass after 12 weeks
Change from baseline fat mass after 12 weeks
Change from baseline muscle mass after 12 weeks
Change from baseline muscle mass after 12 weeks

Full Information

First Posted
January 6, 2022
Last Updated
July 30, 2023
Sponsor
Buddhist Tzu Chi General Hospital
Collaborators
Laurel Corporation, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT05243472
Brief Title
Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults
Official Title
Clinical Efficacy of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Community-Dwelling Older Adults:A 12-Week Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Buddhist Tzu Chi General Hospital
Collaborators
Laurel Corporation, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 among community-dwelling older adults. Participants are randomly assigned to either an intervention group, which is provided one commercial soup (24-30g of protein) per day for 12 weeks, or the control group, which does not receive this supplement. The investigators also assess the frail status, Mini-Mental Status Examination, Geriatric Depression Scale, Mini Nutritional Assessment, WHOQOL-BREF, and blood tests as outcome measures.
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 syndrome of "sarcopenia" in the elderly. In addition to age, risk factors related to sarcopenia include living alone, excessive drinking, lack of physical activity, malnutrition, and oral and dental problems. Among them, lack of physical activity and malnutrition are considered potential risk factors for preventing or improving sarcopenia. Sufficient protein intake is an important method for frail elderly people to improve malnutrition and further prevent or reverse sarcopenia. There were few studies in the past. Some studies had enrolled older adults with sarcopenia, but the participants did not necessarily have nutritional risks; other studies had enrolled individuals with nutritional risks but without complete evaluation for sarcopenia (especially muscle mass). In addition, the components of nutritional supplements should also be adjusted in response to different dietary preferences. For example, past studies have rarely provided protein-enriched nutritional supplements that can be used by Lacto-vegetarian. Therefore, this study aims to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults with risk of sarcopenia and malnutrition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Muscle Loss, Malnutrition
Keywords
Older adults, Sarcopenia, Malnutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This program is designed as a parallel randomized intervention. The primary purpose of this program is Prevention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will not receive any intervention during the study period.
Arm Title
Protein nutritional supplement group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive protein-enriched soups (24-30g of protein) per day for 12 weeks. Protein may come from either soy, bean or milk products.
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein nutritional supplement
Intervention Description
Participants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products.
Primary Outcome Measure Information:
Title
Changes from baseline muscle strength measure by hand grip strength after 12 weeks
Description
measured by hand grip strength
Time Frame
baseline, 12 weeks
Title
Change from baseline walking speed after 12 weeks
Description
measured by six-meter walking speed
Time Frame
baseline, 12 weeks
Title
Changes from baseline physical performance after 12 weeks
Description
measured by Short Physical Performance Battery
Time Frame
baseline, 12 weeks
Title
Changes from baseline frailty after 12 weeks
Description
measured by Clinical Frailty Scale
Time Frame
baseline, 12 weeks
Title
Changes from baseline frail status after 12 weeks
Description
measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale
Time Frame
baseline, 12 weeks
Title
Changes from baseline cognition after 12 weeks
Description
measured by Mini-Mental Status Examination
Time Frame
baseline, 12 weeks
Title
Changes from baseline depression after 12 weeks
Description
measured by Geriatric Depression Scale
Time Frame
baseline, 12 weeks
Title
Changes from baseline quality of life after 12 weeks
Description
measured by WHOQOL-BREF (Taiwan Version)
Time Frame
baseline, 12 weeks
Title
Changes from baseline physical activity after 12 weeks
Description
measured by the International Physical Activity Questionnaire (IPAQ)
Time Frame
baseline, 12 weeks
Title
Changes from baseline nutritional status after 12 weeks
Description
measured by Mini-Nutritional Assessment-Short Form (MNA-SF)
Time Frame
baseline, 12 weeks
Title
Changes from baseline dietary assessment after 12 weeks
Description
measured by Food Frequency Questionnaires (FFQ)
Time Frame
baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline complete blood count 12 weeks
Description
Change from baseline complete blood count 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline differential count 12 weeks
Description
Change from baseline differential count 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Description
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks
Description
Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks
Description
Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Description
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of Creatinine after 12 weeks
Description
Change from baseline concentration of Creatinine after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of sodium after 12 weeks
Description
Change from baseline concentration of sodium after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of potassium after 12 weeks
Description
Change from baseline concentration of potassium after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of uric acid after 12 weeks
Description
Change from baseline concentration of uric acid after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of total protein after 12 weeks
Description
Change from baseline concentration of total protein after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of albumin after 12 weeks
Description
Change from baseline concentration of albumin after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of globulin after 12 weeks
Description
Change from baseline concentration of globulin after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of cholesterol after 12 weeks
Description
Change from baseline concentration of cholesterol after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Description
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Description
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of triglyceride after 12 weeks
Description
Change from baseline concentration of triglyceride after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of fasting glucose after 12 weeks
Description
Change from baseline concentration of fasting glucose after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Description
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of fasting insulin after 12 weeks
Description
Change from baseline concentration of fasting insulin after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of Vitamin D after 12 weeks
Description
Change from baseline concentration of Vitamin D after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of Vitamin B12 after 12 weeks
Description
Change from baseline concentration of Vitamin B12 after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of homocysteine after 12 weeks
Description
Change from baseline concentration of homocysteine after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of cystatin C after 12 weeks
Description
Change from baseline concentration of cystatin C after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline concentration of DHEA-S after 12 weeks
Description
Change from baseline concentration of DHEA-S after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline body weight after 12 weeks
Description
Change from baseline body weight after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline fat mass after 12 weeks
Description
Change from baseline fat mass after 12 weeks
Time Frame
baseline, 12 weeks
Title
Change from baseline muscle mass after 12 weeks
Description
Change from baseline muscle mass after 12 weeks
Time Frame
baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hui Loh, MD.PhD.
Phone
+886-3-8561825
Ext
17607
Email
twdoc1960@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hui Loh, MD.PhD.
Organizational Affiliation
Buddhist Tzu Chi General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
ZIP/Postal Code
97071
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Lun Kao, MD
Phone
+886-3-8561825
Ext
15599
Email
stevenkao7434@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Protein-Enriched Lacto-Vegetarian Soup on Muscle Mass and Muscle Strength Among Older Adults

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