Buddhist Tzu Chi General Hospital
Hualien City, 97071, Taiwan
NCT Number: NCT05243472
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.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Hualien City, 97071, Taiwan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products.
Time frame: baseline, 12 weeks
measured by hand grip strength
Time frame: baseline, 12 weeks
measured by six-meter walking speed
Time frame: baseline, 12 weeks
measured by Short Physical Performance Battery
Time frame: baseline, 12 weeks
measured by Clinical Frailty Scale
Time frame: baseline, 12 weeks
measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale
Time frame: baseline, 12 weeks
measured by Mini-Mental Status Examination
Time frame: baseline, 12 weeks
measured by Geriatric Depression Scale
Time frame: baseline, 12 weeks
measured by WHOQOL-BREF (Taiwan Version)
Time frame: baseline, 12 weeks
measured by the International Physical Activity Questionnaire (IPAQ)
Time frame: baseline, 12 weeks
measured by Mini-Nutritional Assessment-Short Form (MNA-SF)
Time frame: baseline, 12 weeks
measured by Food Frequency Questionnaires (FFQ)
Time frame: baseline, 12 weeks
Change from baseline complete blood count 12 weeks
Time frame: baseline, 12 weeks
Change from baseline differential count 12 weeks
Time frame: baseline, 12 weeks
Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Creatinine after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of sodium after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of potassium after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of uric acid after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of total protein after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of albumin after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of globulin after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of cholesterol after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of triglyceride after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of fasting glucose after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of fasting insulin after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Vitamin D after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of Vitamin B12 after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of homocysteine after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of cystatin C after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline concentration of DHEA-S after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline body weight after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline fat mass after 12 weeks
Time frame: baseline, 12 weeks
Change from baseline muscle mass after 12 weeks
Buddhist Tzu Chi General Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05860556
Atrophy, Malnutrition
Pavia, PV, Italy
View Trial DetailsNCT05212285
Atrophy, Bronchial Neoplasms
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT05795556
Atrophy, Fall Patients
Copenhagen, Hellerup, Denmark
View Trial DetailsNCT06829121
Atrophy, Muscle Loss
Mainz, Rhineland-Palatinate, Germany
View Trial Details