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

The Effect of Medical Nutrition Therapy on Anthropometric Measurements and Blood Parameters in Sarcopenic Obesity Patients Receiving Peritoneal Dialysis Treatment

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenic Obesity; Peritoneal Dialysis Complication
• Intervention / Treatment: Other: medical nutrition therapy in kidney diseases

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dietary and Behavioral Change Group; 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.

Other: medical nutrition therapy in kidney diseases; Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in muscle strength	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.	Baseline to 3 months after diet programme
Change in the skeletal muscle mass	Skeletal muscle mass (kg) will be measured by using bioelectrical impedance analysis.	Baseline to 3 months after diet programme
Change in the physical performance	4-meter walking speed test will be performed. A walking speed of ≤0.8 m/sec is considered as an indicator of severe sarcopenia.	Baseline to 3 months after diet programme
Change of the fat mass	Fat mass (kg) will be measured by using bioelectrical impedance analysis.	Baseline to 3 months after diet programme
Changes of percentage of body fat	Percentage of body fat will be measured by using bioelectrical impedance analysis.	Baseline to 3 months after diet programme
Changes of body mass index	The weight and height will be combined to report BMI in kg/m2.	Baseline to 3 months after diet programme

Collaborators and Investigators

• Sponsor: Atlas University
• Investigators: Principal Investigator: Ayşe Betül Demirbaş, Atlas University

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2023
• Primary Completion (Actual): May 8, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 21, 2023
• First Posted (Actual): April 4, 2023

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: ABDemirbasPD

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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