The Effect Of Medical Nutritional Therapy On Patients With Sarcopenic Obesity Receiving Peritoneal Dialysis Treatment

Not Applicable

Completed

• Conditions: Peritoneal Dialysis Complication; Sarcopenic Obesity
• Interventions: Other: medical nutrition therapy in kidney diseases

• Registration Number: NCT05797181
• Lead Sponsor: Atlas University

Brief Summary

In this study, it was aimed to evaluate the effectiveness of medical nutrition therapy to be applied to patients with sarcopenic obesity receiving peritoneal dialysis treatment by measuring anthropometric measurements and blood parameters.

Detailed Description

Efficacy of medical nutrition therapy in patients with sarcopenic obesity receiving peritoneal dialysis treatment, general information form after patients filled in the voluntary consent form, SARC-F questionnaire as sarcopenia screening test, International Physical Activity Questionnaire (IPAQ), muscle mass, muscle strength, physical performance, BIA measurement, anthropometric measurements, laboratory findings and three-day food consumption records will be evaluated.

Study Timeline

• Study Start: 2023-02-07
• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-04
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Volunteering to participate in research
• Be between the ages of 18-70
• To receive peritoneal dialysis treatment and to come to the hospital regularly once a month for treatment

Exclusion Criteria

• Presence of any other disease that causes muscle wasting
• Patients using any supplement or enteral product in their diet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dietary and Behavioral Change Group	medical nutrition therapy in kidney diseases	The experimental group will be required to adhere to a diet consisting of a 10-15% reduction in carbohydrate and a 1.2-1.4 g/kg body weight/day intake of protein. The participants will receive 4 times face-to-face meetings (on the first day and on week 1,5 and 9). Each face-to-face interview will last approximately 30 minutes. During the interview researcher will help the participants to determine their nutritional behaviors, plan and implement the diet.

Primary Outcome Measures

Name	Time	Method
Changes of body mass index	Baseline to 3 months after diet programme	The weight and height will be combined to report BMI in kg/m2.
Change in the physical performance	Baseline to 3 months after diet programme	4-meter walking speed test will be performed. A walking speed of ≤0.8 m/sec is considered as an indicator of severe sarcopenia.
Change in muscle strength	Baseline to 3 months after diet programme	Handgrip strength (kg) will be measured by using the CAMRY EH101 dynamometer. Hand grip strength \<16 kg for women and \<27 kg for men indicates low muscle strength.
Changes of percentage of body fat	Baseline to 3 months after diet programme	Percentage of body fat will be measured by using bioelectrical impedance analysis.
Change in the skeletal muscle mass	Baseline to 3 months after diet programme	Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.
Change of the fat mass	Baseline to 3 months after diet programme	Fat mass (kg) will be measured by using bioelectrical impedance analysis.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey