Tonsil DiseaseNCT06247436
Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period
A study testing Branch Chained Amino Acids in people with Tonsil Disease, run by Szeged University at 1 site in Hungary.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsil Disease
- What is being tested?
- Branch Chained Amino Acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHungary
- Study dates
- 1 Apr 2023to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- indication of tonsillectomy
- age between 20-40 years
Who cannot join
- metabolic diseases,
- haematologic disorders
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery
Szeged, 6725
About this study
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.
Read the 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.
- Conditions
- Tonsil Disease
- Being tested
- Branch Chained Amino Acids
- Keywords
- body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branch Chained Amino AcidsDietary supplement
postoperative BCAA consumption
| Study group | Role | What they receive |
|---|---|---|
| Branch Chained Amino Acids-4mg | Experimental | 4g BCAA, solved in water, twice daily Receives: Dietary Supplement: Branch Chained Amino Acids |
| Control | No intervention | no consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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 %
Measured: 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
Measured: 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
Measured: 21 days
determination of changes in blood parametersof Liver Function (U/l)
alterations of GOT,GGT,GPT values in Units of Measure: U/l
Measured: 21 days
Secondary outcomes (1)
effects of branched chain amino acid consumption
determination of the skeletal muscle mass loss in kg after BCAA consumption
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Apr 2023
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tonsil DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Kiricsi, MD, PhD, Principal investigator, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247436
- Sponsor's protocol ID
- OGYÉI/56432-2/2023
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alternations in Body Composition of Tonsillectomy Patients During the Recovery Period
- ClinicalTrials.gov ID
- NCT06247436
- Acronym / sponsor ID
- OGYÉI/56432-2/2023
- Conditions
- Tonsil Disease
- Keywords
- body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branch Chained Amino Acids-4mg | Experimental | Dietary Supplement: Branch Chained Amino Acids4g BCAA, solved in water, twice daily |
| Control | No intervention | –no consumption |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- indication of tonsillectomy
- age between 20-40 years
Key exclusion criteria (2 listed)
- metabolic diseases,
- haematologic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branch Chained Amino Acidspostoperative BCAA consumption | Dietary supplement | Branch Chained Amino Acids-4mg |
Primary outcome
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.
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
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.
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
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 %
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
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
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
1 secondary outcome
effects of branched chain amino acid consumption
Time frame: 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Tonsil Disease
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Enrolling by invitationObservational study
Fasting Time and Post-tonsillectomy Pain
Tonsillar Disorder
Recruiting
Photon Therapy Versus Proton Therapy in Early Tonsil Cancer.
Tonsil Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Kiricsi, MD, PhD principal investigator
Szeged University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Branch Chained Amino Acids in people with Tonsil Disease, run by Szeged University at 1 site in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative changes of body weight (kg) after tonsillectomy (time frame: 21 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.