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

Last updated: August 5, 2024
Sponsor: Buddhist Tzu Chi General Hospital
Overall Status: Completed

Phase

N/A

Condition

Diet And Nutrition

Weight Loss

Sarcopenia

Treatment

Protein nutritional supplement

Clinical Study ID

NCT05243472
IRB110-246-A
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • People aged 65 years or older

  • People with nutritional risk: Mini Nutritional Assessment (MNA) is less than orequal to eleven points.

  • People with risk of sarcopenia: SARC-F questionnaire greater than or equal to fourpoints 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

Exclusion Criteria:

  • People that are unable to cooperate with or acceptlacto-vegetarian-based/nuts/gluten foods, such as those who are allergic to dietarycontent, nuts or gluten, etc.

  • According to the PI's judgment, people with severe or poorly controlled conditionsinclude acute diseases, severe infections, severe abnormal laboratory tests, orserious 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 ofassessment and testing

  • People with malignant tumors that have just been diagnosed or are undergoingtreatment or are still at risk of recurrence

  • People are known to be infected with human immunodeficiency virus or HIVantibody-positive.

  • People have received hormone therapy within three months before the trial or areexpected to receive hormone therapy during the trial

  • People are currently or expected to join any other physical training courses ornutrition plans during the trial

  • Others are based on the judgment of the PI that participating in this trial mayadversely affect the safety of the subjects, hinder the progress of the experiment,or interfere with the evaluation of the outcomes of the trial.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Protein nutritional supplement
Phase:
Study Start date:
March 01, 2022
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Buddhist Tzu Chi General Hospital

    Hualien City, 97071
    Taiwan

    Site Not Available

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