Bioindicators Associated With Sarcopenia Before and After Intensive Lifestyle Intervention

The goal of this clinical trial is to explore whether the bioindicators of body composition, nutrition-related indicators (lymphocytes, albumin), lipids, and thyroid hormones are associated with sarcopenia and the changes in these indicators after an intensive lifestyle intervention. The main questions it aims to answer are:

• whether the bioindicators such as lymphocytes, albumin, lipids, thyroid hormones, fat mass, fat-free mass, and basal metabolic mass are associated with the development of sarcopenia.
• the changes of these bioindicators that occur in older adults after going through an intensive intervention.

Participants will receive a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions are co-designed through a nutritionist and rehabilitation physician.

Researchers will compare bioindicators in the sarcopenia group before and after intensive lifestyle intervention to determine the association with sarcopenia.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Combination product: 3-month intensive intervention

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Suzhou Municipal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1) Resident elderly aged 65-90 years old in the district.
• 2) Voluntary participation in the trial and signing the informed consent form.

Exclusion Criteria:

• 1) People with systemic severe diseases, organ failure, malignant tumors, neuromuscular degenerative diseases, or active weight loss.
• 2) People with cognitive impairment, incapacitation, or severe mental illnesses who cannot cooperate with the test.
• 3) People with cardiac pacemakers and artificial joint implantation or others who cannot undergo the BIA test.
• 4) People with severe cardiorespiratory dysfunction and physical disabilities who cannot complete the exercise training.
• 5) Incomplete data, refusal to participate in the survey, body composition analysis, and blood collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sarcopenia group; After completing screening, 30 subjects in the sarcopenia group received a 3-month intensive intervention consisting of an intensive nutritional intervention and an individually designed exercise intervention. Nutritional and exercise prescriptions were co-designed through a nutritionist and rehabilitation physician.	Combination product: 3-month intensive intervention; Intensive nutritional interventions were as follows: i）Estimation of ideal body weight according to height, calculation of calories by giving 30-40kcal/kg/day according to BMI stratification, and calculation of daily protein requirement at 1.5g/kg/day, which was finally converted into daily dietary recommendations according to the results of the calculations. ii）Distribution of additional protein supplementation by whey protein, each sachet containing 15g of whey protein. The resistance training program included 5 min of warm-up, 20 min of muscle strength training, and 5 min of slow walking and was performed three times a week. Resistance training involved a dumbbell and sandbags as weights for the major muscles of the upper and lower limbs. In the study, aerobic training is brisk walking or jogging for 30 minutes/day, five times a week.; Other Names: Sarcopenia group
No Intervention: Normal control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMMI(appendicular muscle mass index)	Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height^2 (kg/m^2).	baseline and 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fat mass	Bioelectrical impedance analysis was used to obtain fat mass. The unit of fat mass was represented as kilogram.	baseline and 3 month
Fat-free mass	Bioelectrical impedance analysis was used to obtain fat-free mass. The unit of fat-free mass was represented as kilogram.	baseline and 3 month
Basal metabolic mass	Bioelectrical impedance analysis was used to obtain basal metabolic mass. The unit of basal metabolic mass was represented as kilocalorie.	baseline and 3 month
Lymphocyte count	Lymphocyte counts were detected using a fully automated hematology analyzer (Mindray BC-6800, Shenzhen, China). The unit of lymphocyte count was represented as 10^9/L.	baseline and 3 month
Albumin	Albumin was detected using a fully automated biochemistry analyzer (Hitachi 7600, Hitachi, Ltd., Tokyo, Japan). The unit of albumin was represented as g/L.	baseline and 3 month
Five items of blood lipid (triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), very low-density lipoprotein cholesterol (VLDL-C))	Five items of blood lipid were detected using a fully automated biochemistry analyzer (Hitachi 7600, Hitachi, Ltd., Tokyo, Japan). The units of the five items of blood lipid were all represented as mmol/L.	baseline and 3 month
Thyroid hormones (thyroid stimulating hormone (TSH), free thyroxine (FT4), and free triiodothyronine (FT3))	Thyroid hormones were measured by chemiluminescence immunoassay (Abbott I2000, Abbott, Chicago, USA). The units of FT4 and FT3 were represented as pmol/L. The unit of TSH was represented as μIU/mL.	baseline and 3 month

Collaborators and Investigators

• Sponsor: Lijun Yang
• Collaborators: Suzhou Municipal Hospital
• Investigators: Study Director: Lijun j Yang, Master, Suzhou Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): July 31, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Estimated): November 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Sarcopenia; Nutritional intervention; Exercise intervention; Intensive lifestyle intervention; Bioindicators
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: LCZX201911

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No