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

NCT06537115 | Recruiting Phase 4

• 1 other identifier: KY2024041
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; intervention; idecalcitol; whey protein powder; exercise

Outcome Measures

Primary Outcomes (1)

• muscle mass

  The DXA equipment is used to detect the muscle mass.

  up to 24 weeks

Secondary Outcomes (3)

• Grip strength

  up to 24 weeks

• 6-meter walking speed

  up to 24 weeks

• incidence of adverse reactions

  up to 24 weeks

Study Arms (3)

Control group

OTHER

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

experimental group 1

OTHER

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; Dietary Supplement: whey protein powder

experimental group 2

OTHER

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; Dietary Supplement: whey protein powder; Drug: Eldecalcitol

Interventions

exercise BEHAVIORAL

progressive resistance exercise

Control group; experimental group 1; experimental group 2

whey protein powder DIETARY_SUPPLEMENT

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.

experimental group 1; experimental group 2

Eldecalcitol DRUG

Eldecalcitol soft gel capsules are taken at an oral dose of 0.75μg once a day for 12 consecutive weeks.

experimental group 2

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (5)

The First People's Hospital of Chun'an County

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

RECRUITING

Huzhou Nanxun District People's Hospital

Huzhou, Zhejiang, China

RECRUITING

Xianju People's Hospital

Taizhou, Zhejiang, China

RECRUITING

Dinghai Central Hospital of Zhoushan City

Zhoushan, Zhejiang, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32033882 BACKGROUND

• 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.

  PMID: 31171417 BACKGROUND

• 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.

  PMID: 33349543 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise; eldecalcitol

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jianfang Ni, bachelor

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianfeng Tu, Doctor

CONTACT

+86 15925669920; tutu5800@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 5, 2024
• Study Start: June 16, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: August 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the completion of the study,for 3 years
• Access Criteria: username and password

Locations

CN (5)