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

NCT05797181 | Completed

• 1 other identifier: ABDemirbasPD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Dialysis Complication; Sarcopenic Obesity

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Dietary and Behavioral Change Group

EXPERIMENTAL

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

Interventions

medical nutrition therapy in kidney diseases OTHER

Planning and implementation of diets containing high protein, low potassium, low phosphorus, personalized adjusted carbohydrates

Dietary and Behavioral Change Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Marmara University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Nutrition Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Ayşe Betül Demirbaş

  Atlas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: April 4, 2023
• Study Start: February 7, 2023
• Primary Completion: May 8, 2023
• Study Completion: May 15, 2023
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

TU (1)