NCT06247436

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

February 7, 2024

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 17, 2023

Last Update Submit

February 6, 2024

Conditions

Tonsil Disease

Keywords

body composition

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • effects of branched chain amino acid consumption

    21 days

Study Arms (2)

Branch Chained Amino Acids-4mg

EXPERIMENTAL

4g BCAA, solved in water, twice daily

Dietary Supplement: Branch Chained Amino Acids

Control

NO INTERVENTION

no consumption

Interventions

Branch Chained Amino AcidsDIETARY_SUPPLEMENT

postoperative BCAA consumption

Branch Chained Amino Acids-4mg

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • indication of tonsillectomy
  • age between 20-40 years

You may not qualify if:

  • metabolic diseases,
  • haematologic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery

Szeged, 6725, Hungary

Location

Study Officials

  • Agnes Kiricsi, MD, PhD

    Szeged University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2023

First Posted

February 7, 2024

Study Start

April 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

February 7, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

HU(1)