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

Sarcopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05243472
• Other study ID #: IRB110-246-A
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2023
• Source: Buddhist Tzu Chi General Hospital
• Contact: Ching-Hui Loh, MD.PhD.
• Phone: +886-3-8561825
• Email: twdoc1960[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Malnutrition
• Muscle Loss
• Sarcopenia

Intervention

Dietary Supplement:
• Protein nutritional supplement
Participants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products.

Locations

Country	Name	City	State
Taiwan	Buddhist Tzu Chi General Hospital	Hualien City

Sponsors (2)

Lead Sponsor	Collaborator
Buddhist Tzu Chi General Hospital	Laurel Corporation, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline muscle strength measure by hand grip strength after 12 weeks	measured by hand grip strength	baseline, 12 weeks
Primary	Change from baseline walking speed after 12 weeks	measured by six-meter walking speed	baseline, 12 weeks
Primary	Changes from baseline physical performance after 12 weeks	measured by Short Physical Performance Battery	baseline, 12 weeks
Primary	Changes from baseline frailty after 12 weeks	measured by Clinical Frailty Scale	baseline, 12 weeks
Primary	Changes from baseline frail status after 12 weeks	measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale	baseline, 12 weeks
Primary	Changes from baseline cognition after 12 weeks	measured by Mini-Mental Status Examination	baseline, 12 weeks
Primary	Changes from baseline depression after 12 weeks	measured by Geriatric Depression Scale	baseline, 12 weeks
Primary	Changes from baseline quality of life after 12 weeks	measured by WHOQOL-BREF (Taiwan Version)	baseline, 12 weeks
Primary	Changes from baseline physical activity after 12 weeks	measured by the International Physical Activity Questionnaire (IPAQ)	baseline, 12 weeks
Primary	Changes from baseline nutritional status after 12 weeks	measured by Mini-Nutritional Assessment-Short Form (MNA-SF)	baseline, 12 weeks
Primary	Changes from baseline dietary assessment after 12 weeks	measured by Food Frequency Questionnaires (FFQ)	baseline, 12 weeks
Secondary	Change from baseline complete blood count 12 weeks	Change from baseline complete blood count 12 weeks	baseline, 12 weeks
Secondary	Change from baseline differential count 12 weeks	Change from baseline differential count 12 weeks	baseline, 12 weeks
Secondary	Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks	Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks	Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks	Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks	Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of Creatinine after 12 weeks	Change from baseline concentration of Creatinine after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of sodium after 12 weeks	Change from baseline concentration of sodium after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of potassium after 12 weeks	Change from baseline concentration of potassium after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of uric acid after 12 weeks	Change from baseline concentration of uric acid after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of total protein after 12 weeks	Change from baseline concentration of total protein after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of albumin after 12 weeks	Change from baseline concentration of albumin after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of globulin after 12 weeks	Change from baseline concentration of globulin after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of cholesterol after 12 weeks	Change from baseline concentration of cholesterol after 12 weeks	baseline, 12 weeks
Secondary	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	baseline, 12 weeks
Secondary	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	baseline, 12 weeks
Secondary	Change from baseline concentration of triglyceride after 12 weeks	Change from baseline concentration of triglyceride after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of fasting glucose after 12 weeks	Change from baseline concentration of fasting glucose after 12 weeks	baseline, 12 weeks
Secondary	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	baseline, 12 weeks
Secondary	Change from baseline concentration of fasting insulin after 12 weeks	Change from baseline concentration of fasting insulin after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of Vitamin D after 12 weeks	Change from baseline concentration of Vitamin D after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of Vitamin B12 after 12 weeks	Change from baseline concentration of Vitamin B12 after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of homocysteine after 12 weeks	Change from baseline concentration of homocysteine after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of cystatin C after 12 weeks	Change from baseline concentration of cystatin C after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline concentration of DHEA-S after 12 weeks	Change from baseline concentration of DHEA-S after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline body weight after 12 weeks	Change from baseline body weight after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline fat mass after 12 weeks	Change from baseline fat mass after 12 weeks	baseline, 12 weeks
Secondary	Change from baseline muscle mass after 12 weeks	Change from baseline muscle mass after 12 weeks	baseline, 12 weeks