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

NCT ID: NCT05243472

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2023-08-31

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.

Conditions

Sarcopenia; Muscle Loss; Malnutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Protein nutritional supplement group

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.

Group Type: EXPERIMENTAL

Protein nutritional supplement

Intervention Type: DIETARY_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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laurel Corporation, Taiwan

UNKNOWN

Sponsor Role: collaborator

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Hui Loh, MD.PhD.

Role: PRINCIPAL_INVESTIGATOR

Buddhist Tzu Chi General Hospital

Locations

Buddhist Tzu Chi General Hospital

Hualien City, , Taiwan

Countries

Taiwan

Other Identifiers

IRB110-246-A

Identifier Type: -

Identifier Source: org_study_id