Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period

Tonsil Disease Clinical Trial

Official title:

Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06247436
• Other study ID #: OGYÉI/56432-2/2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: October 2023
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• indication of tonsillectomy

• age between 20-40 years

Exclusion Criteria:

• metabolic diseases,

• haematologic disorders

Related Conditions & MeSH terms

• Tonsil Disease

Intervention

Dietary Supplement:
• Branch Chained Amino Acids
postoperative BCAA consumption

Locations

Country	Name	City	State
Hungary	Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The postoperative changes of body weight (kg) after tonsillectomy	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
Primary	The postoperative changes of skeletal muscle mass (kg) after tonsillectomy	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
Primary	The postoperative changes of Body Fat Mass (kg) after tonsillectomy	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
Primary	The postoperative changes of Body Mass Index (kg/m2) after tonsillectomy	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
Primary	The postoperative changes of Percent Body Fat (%) after tonsillectomy	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
Primary	The postoperative changes of Total Body Water (liter) after tonsillectomy	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
Primary	examination of changes in blood count (mmol/l)	changes in triglyceride, HDL, LDL, Na, K, Ca, Mg, Carbamide, Kreatinine in Units of Measure: mmol/l	21 days
Primary	determination of changes in blood parametersof Liver Function (U/l)	alterations of GOT,GGT,GPT values in Units of Measure: U/l	21 days
Secondary	effects of branched chain amino acid consumption	determination of the skeletal muscle mass loss in kg after BCAA consumption	21 days