Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period

February 6, 2024 updated by: Szeged University
The body composition of individuals undergoing tonsillectomy is assessed through bioimpedance-based measurements conducted immediately before the surgery, as well as on the 7th and 21st days during the postoperative period.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

In the context of interventions affecting the upper alimentary canal-like tonsillectomy-, it is advisable to adhere to a gentle diet until complete wound healing. Additionally, patients may need to modify their eating habits due to discomfort during swallowing. Physical activity is strictly prohibited during this recovery phase, which poses a risk of muscle loss.

Branched-chain amino acids (BCAAs) play a crucial role in sports nutrition. Unlike other amino acids, BCAAs can be directly utilized by muscles without involving the liver. They serve as an immediate energy source for muscles or contribute to the synthesis of new muscle proteins, helping to prevent muscle loss.

At the same time, the investigators also examined the changes that could be detected in the blood and were possibly related to dietary habits.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6725
        • Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • indication of tonsillectomy
  • age between 20-40 years

Exclusion Criteria:

  • metabolic diseases,
  • haematologic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Branch Chained Amino Acids-4mg
4g BCAA, solved in water, twice daily
Dietary supplement: Branch Chained Amino Acids
postoperative BCAA consumption
No Intervention: Control
no consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The postoperative changes of body weight (kg) after tonsillectomy
Time Frame: 21 days
In this study the investigators used Inbody 270, a body bomposition analyzer based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. Weight alternation was registered in kg.
21 days
The postoperative changes of skeletal muscle mass (kg) after tonsillectomy
Time Frame: 21 days
In this study the investigators used Inbody 270, a body bomposition analyzer based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. SMM-Skeletal Muscle Mass alteration was registered in kg
21 days
The postoperative changes of Body Fat Mass (kg) after tonsillectomy
Time Frame: 21 days
In this study the investigators used Inbody 270, a body bomposition analyzer based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. BFM-Body Fat Mass alteration was registered in kg.
21 days
The postoperative changes of Body Mass Index (kg/m2) after tonsillectomy
Time Frame: 21 days
Body weight -registered with InBody 270 - and height of the patient -that not changes in the 3 weeks of time frame of the study- will be combined to report BMI in kg/m2
21 days
The postoperative changes of Percent Body Fat (%) after tonsillectomy
Time Frame: 21 days
In this study the investigators used Inbody 270, a body bomposition analyzer based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. ), PBF-Percent Body Fat alteration was registered is %
21 days
The postoperative changes of Total Body Water (liter) after tonsillectomy
Time Frame: 21 days
In this study the investigators used Inbody 270, a body bomposition analyzer based on multi-frequency Bioelectrical Impedance Analysis(BIA) method that calculated specific body component by differences in impedance indexes of fat, muscle and extracellular body fluid. TBW-Total Body Water alteration was registered in liter
21 days
examination of changes in blood count (mmol/l)
Time Frame: 21 days
changes in triglyceride, HDL, LDL, Na, K, Ca, Mg, Carbamide, Kreatinine in Units of Measure: mmol/l
21 days
determination of changes in blood parametersof Liver Function (U/l)
Time Frame: 21 days
alterations of GOT,GGT,GPT values in Units of Measure: U/l
21 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effects of branched chain amino acid consumption
Time Frame: 21 days
determination of the skeletal muscle mass loss in kg after BCAA consumption
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Investigators

  • Principal Investigator: Agnes Kiricsi, MD, PhD, Szeged University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OGYÉI/56432-2/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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