Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia

Clinical Intervention of Idecalcitol Combined With Whey Protein Powder and Exercise for Sarcopenia：a RCT Trial

This clinical trial is a multicenter, single-blind, prospective, randomized controlled clinical application study. Subjects who met the trial criteria and signed the informed consent form were randomly divided into a control group, an experimental group 1, and an experimental group 2. After enrollment, the control group underwent a comprehensive assessment of their underlying conditions by professional physicians and received routine interventions, including basic nutritional intervention program guidance, progressive resistance exercise intervention program guidance, safety precautions, and symptomatic treatment for different complications, for a total intervention period of 24 weeks. The experimental group 1, in addition to the interventions provided to the control group, received whey protein powder supplementation for 12 weeks. The experimental group 2, on the other hand, received both whey protein powder and eldecalcitol supplementation on top of the interventions given to the control group, also for 12 weeks. The entire intervention period lasted for 24 weeks. Through regular general assessments, blood tests, measurements of muscle mass, muscle strength, and physical function, as well as analyses of negative adverse events, statistical methods were employed to evaluate the safety and efficacy of the comprehensive intervention methods for sarcopenia.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: exercise; Dietary supplement: whey protein powder; Drug: Eldecalcitol

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jianfeng Tu, Doctor; Phone Number: +86 15925669920; Email: tutu5800@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Jianfeng Tu, Doctor; Phone Number: +86 15925669920; Email: tutu5800@163.com
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First People's Hospital of Chun'an County
      • Contact: Yunsheng Li, Bachelor
    • Huzhou, Zhejiang, China
      • Recruiting
      • Huzhou Nanxun District People's Hospital
      • Contact: Haiyang Tang, Master
    • Taizhou, Zhejiang, China
      • Recruiting
      • Xianju People's Hospital
      • Contact: Hui Wu, Doctor
    • Zhoushan, Zhejiang, China
      • Recruiting
      • Dinghai Central Hospital of Zhoushan City
      • Contact: Kairui Deng, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 30 or above;

  • Meeting the diagnostic criteria for sarcopenia according to the definition of AWGS; ③ Able to walk, willing to accept a comprehensive intervention plan, and guarantee to complete the treatment course; ④ Both patients and their families agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

• Resting systolic blood pressure > 200 mmHg or resting diastolic blood pressure > 100 mmHg;

  • Severe heart disease: moderate to severe aortic valve stenosis, acute pericarditis, acute myocarditis, myocardial infarction, uncontrollable arrhythmia;

    • Acute stroke within the past 2 years;

      • Severe airway obstruction;

        • Lower limb fractures in the past 1 year or upper limb fractures in the past 6 months;

          • Hypercalcemia (corrected albumin serum calcium > 2.60 mmol/L);

            • Active malignant tumors; ⑧ Chronic kidney disease stages 5;

              • Mental illness or severe cognitive impairment;

                • Long-term immobilization; ⑪ Other diseases that may interfere with the evaluation of muscle mass, muscle strength, and physical function; ⑫ Unable to cooperate with treatment due to other reasons; ⑬ Life expectancy less than 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; After enrollment, professional doctors will conduct a comprehensive assessment of their basic conditions and provide routine interventions, mainly including basic nutrition intervention program guidance, progressive resistance exercise intervention program guidance, safety protection advice, and symptomatic treatment for different complications, with a total intervention period of 24 weeks.	Behavioral: exercise; progressive resistance exercise
Other: experimental group 1; On the basis of the control group, whey protein powder was given to supplement for 12 weeks.60 grams of protein per day is taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.	Behavioral: exercise; progressive resistance exercise; Dietary supplement: whey protein powder; The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.
Other: experimental group 2; On the basis of the control group, whey protein powder and eldecalcitol were given for supplementation for 12 weeks. (Supplementing whey protein powder: The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient. Supplementing eldecalcitol: eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.)	Behavioral: exercise; progressive resistance exercise; Dietary supplement: whey protein powder; The protein intake is 60 grams per day, taken in three divided doses for 12 consecutive weeks. Attention should be paid to monitoring liver and kidney function, and the dosage of protein powder should be adjusted according to the condition of the patient.; Drug: Eldecalcitol; Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle mass	The DXA equipment is used to detect the muscle mass.	up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip strength	Using a spring dynamometer, stand upright with the elbow joint fully extended, and use the muscle strength of the dominant hand to record the maximum reading (in kg) from three trials.	up to 24 weeks
6-meter walking speed	Record the time required to walk 6 meters from the starting point at a normal speed without decelerating, and use the average result of 3 trials as the recorded walking speed (in m/s).	up to 24 weeks
incidence of adverse reactions	The number of patients with adverse events within a unit time / the total number of patients in the experimental or control group during the same period * 100%.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital
• Investigators: Principal Investigator: Jianfang Ni, bachelor, Zhejiang Provincial People's Hospital

Publications and helpful links

General Publications

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.
• Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3. Erratum In: Lancet. 2019 Jun 29;393(10191):2590. doi: 10.1016/S0140-6736(19)31465-5.
• Maeda K, Imatani J, Moritani S, Kondo H. Effects of eldecalcitol alone or a bone resorption inhibitor with eldecalcitol on bone mineral density, muscle mass, and exercise capacity for postmenopausal women with distal radius fractures. J Orthop Sci. 2022 Jan;27(1):139-145. doi: 10.1016/j.jos.2020.11.009. Epub 2020 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 2, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: exercise; intervention; Sarcopenia; idecalcitol; whey protein powder
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia; Physiological Effects of Drugs; Bone Density Conservation Agents; Eldecalcitol
• Other Study ID Numbers: KY2024041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The raw data will be uploaded to the ResMan platform for raw data sharing, whose website is: http://www.medresman.org.cn/.
• IPD Sharing Time Frame: After the completion of the study,for 3 years
• IPD Sharing Access Criteria: username and password
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

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