FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/071880 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 26/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effect of omega-3 fatty acid consumption on hearing 
Scientific Title of Study   Influence of omega-3 fatty acid consumption on hearing functions of healthy young adults: A Case- Control Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parth Singhania 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  8088188537  
Fax    
Email  parth1.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Ms Priya G 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9480041575  
Fax    
Email  priya.g@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Ms Priya G 
Designation  Assistant Professor  
Affiliation  Manipal College of Health Professions 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9480041575  
Fax    
Email  priya.g@manipal.edu  
 
Source of Monetary or Material Support  
Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal 
 
Primary Sponsor  
Name  Parth Singhania 
Address  Department of Speech and Hearing, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ms Priya G  Kasturba Hospital  Room number 309, Dr AV Baliga Block, Department of Speech and Hearing, CTC block 3rd floor, Above A2 ward, Madhav Nagar, Manipal
Udupi
KARNATAKA 		 9480041575

priya.g@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy young Adults ( 18-25 years) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Age range between 18 to 25 years.
2.Consisting of both Male and Female population
3. Case Group – Healthy young adults who consume fish rich in omega-3fatty acids (2.2 gm/day)
4. Control Group – Healthy young adults who do not consume fish rich in omega-3 fatty acids. (2.2 gm/day)
 
 
ExclusionCriteria 
Details  1.Individuals with middle ear problems or pre-existing hearing loss
2.Individuals who consume Omega-3-fatty acid supplements
3.Individuals who are on a specific diet
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.ABR (Auditory Brainstem Response):
Amplitude (microvolt)
Latency of wave V (millisecond)
2.ECochG (Electrocochleography):
AP/SP Ratio
3. DPOAE
Signal to Noise Ratio – 6 (dB)
 		 Baseline
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/08/2024 
Date of Study Completion (India) 15/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Aim: To study the influence of omega-3 fatty acid consumption on hearing functions of healthy young adults: A Case-Control Study

Objective: To compare the hearing functions in healthy young adults with and without consumption of the recommended dietary allowance of omega-3 fatty acids

A study will determine the influence of omega-3 fatty acid consumption on hearing functions of healthy young adults. Young adults are more susceptible to hearing loss because of their unfavourable pattern of listening which damages their cochlear functioning. Methods to preserve their hearing functions are very important since their listening needs are higher. This brings to the need of the current study where the beneficial effects of omega 3 fatty acid consumption on cochlear functioning will to be explored in healthy young adults which will provide detailed insights into the functioning of the cochlea. The Number of healthy adults expected to participate in this study includes 62 (31 in each group). A screening procedure will be performed where a detailed case history will be obtained regarding the hearing. A food frequency questionnaire will be administered by interviewing the participants regarding their food consumption. After this, diagnostic tests in audiology including Otoacoustic Emissions (OAE), Auditory Brainstem Response (ABR), and Electrocochleography (ECochG) will be administered. The duration of the study will be 10 months.

 
Close