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

NCT05243472 | Completed

• 1 other identifier: IRB110-246-A
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Muscle Loss; Malnutrition

Keywords

Older adults; Sarcopenia; Malnutrition

Outcome Measures

Primary Outcomes (11)

• Changes from baseline muscle strength measure by hand grip strength after 12 weeks

  measured by hand grip strength

  baseline, 12 weeks

• Change from baseline walking speed after 12 weeks

  measured by six-meter walking speed

  baseline, 12 weeks

• Changes from baseline physical performance after 12 weeks

  measured by Short Physical Performance Battery

  baseline, 12 weeks

• Changes from baseline frailty after 12 weeks

  measured by Clinical Frailty Scale

  baseline, 12 weeks

• Changes from baseline frail status after 12 weeks

  measured by Fatigue, Resistance, Ambulation, Illnesses, \& Loss of Weight scale

  baseline, 12 weeks

• Changes from baseline cognition after 12 weeks

  measured by Mini-Mental Status Examination

  baseline, 12 weeks

• Changes from baseline depression after 12 weeks

  measured by Geriatric Depression Scale

  baseline, 12 weeks

• Changes from baseline quality of life after 12 weeks

  measured by WHOQOL-BREF (Taiwan Version)

  baseline, 12 weeks

• Changes from baseline physical activity after 12 weeks

  measured by the International Physical Activity Questionnaire (IPAQ)

  baseline, 12 weeks

• Changes from baseline nutritional status after 12 weeks

  measured by Mini-Nutritional Assessment-Short Form (MNA-SF)

  baseline, 12 weeks

• Changes from baseline dietary assessment after 12 weeks

  measured by Food Frequency Questionnaires (FFQ)

  baseline, 12 weeks

Secondary Outcomes (28)

• Change from baseline complete blood count 12 weeks

  baseline, 12 weeks

• Change from baseline differential count 12 weeks

  baseline, 12 weeks

• Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks

  baseline, 12 weeks

• Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks

  baseline, 12 weeks

• Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks

  baseline, 12 weeks

Study Arms (2)

Control group

NO INTERVENTION

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

Protein nutritional supplement group

EXPERIMENTAL

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.

Dietary Supplement: Protein nutritional supplement

Interventions

Protein nutritional supplement 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.

Protein nutritional supplement group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead
• Laurel Corporation, Taiwan: collaborator

Study Sites (1)

Buddhist Tzu Chi General Hospital

Hualien City, 97071, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy; Malnutrition

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ching-Hui Loh, MD.PhD.

  Buddhist Tzu Chi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This program is designed as a parallel randomized intervention. The primary purpose of this program is Prevention.

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)