CTRI

1. Title

Influence of Omega-3 Fatty Acid Consumption on Auditory Processing Skills in Healthy Young Adults: A Case-Control Study

2. Type of Study

Prospective cross-sectional study

3. Aims & Objectives

Aim: To understand the influence of omega-3 fatty acid consumption on auditory processing skills in healthy young adults.

Objectives: To compare auditory processing skills (temporal processing, binaural integration, and speech in noise) between healthy young adults who consume the recommended dietary allowance of omega-3 fatty acids and those who do not.

4. Justification for Study

Significance: Omega-3 fatty acids increase cochlear vascularity, preserving blood flow and potentially preventing hearing damage.

Rationale: Most studies focus on peripheral auditory functions, but higher auditory functions like central auditory processing have not been explored in relation to omega-3 consumption.

Need: Central auditory processing is crucial for language comprehension and auditory perception, especially in complex listening situations. The impact of omega-3 on these skills in young adults has not been explored.

5. Departments Involved

Department of Speech and Hearing and Department of Clinical Nutrition and Dietetics, MCHP, MAHE

6. Study Period

Duration: 8 months.

Sample Size: 140 participants (70 controls and 70 cases).

Calculation: At a 5% significance level (Î±) with 80% power (1-Î²) and an expected effect size of 0.5, the minimum required sample size per group is 64. Accounting for a 10% dropout rate, the total sample size is 140 (70 per group).

7. Sample Size Calculation

Formula:

Here, - standard deviation (1^st group).

-standard deviation (2^nd group).

â€“ mean difference among the samples.

8. Materials and Methods

a) Inclusion and Exclusion Criteria:

Inclusion:

Healthy young adults (18-25 years) with normal hearing sensitivity.

Both genders.

Control group: Does not consume the required amount of omega-3 fatty acids (2.2 grams/day).

Case group: Consumes the required amount of omega-3 fatty acids (2.2 grams/day).

Exclusion:

Individuals taking omega-3 supplements.

Individuals on any specific nutritional diet (e.g., Mediterranean diet, ketogenic diet).

c) Statistical Methods:

Data Analysis:

Categorical data: Frequency tables and percentages.

Quantitative data: Described using mean and standard deviation or median and interquartile range.

Tests: Two-sample independent t-test and One-way ANOVA for group comparisons. Non-parametric tests if normality and homogeneity of variance are violated.

d) Tools Used:

Food Frequency Questionnaire (FFQ): A self-administered questionnaire designed to gather data on food consumption patterns.

e) Procedures:

Approvals: Obtain from Institutional Research Committee (IRC), Institutional Ethics Committee (IEC), and Clinical Trials Registry of India (CTRI).

Recruitment: Approach college students from MAHE, collect food habits information, and obtain consent.

Testing:

Hearing Levels: Assess and ensure normal limits before recruitment.

Food Frequency Questionnaire: To determine omega-3 fatty acid intake using Diet Calc version 1.5.0.

Grouping: Based on omega-3 intake (control and case groups).

Auditory Processing Tests:

Adaptive Test of Temporal Resolution (ATTR): To assess temporal processing.

Dichotic Digit Test-Kannada: To measure binaural integration.

Spatial Separation Sentence Test-Kannada: To assess speech perception in noise.

9. Detailed Description of Procedure/Processes

Recruitment and Grouping: Participants will be recruited, grouped based on omega-3 intake, and will undergo auditory processing tests in a soundproof room.

Testing Time: Approximately 1.5 hours per participant.

Tests:

ATTR: Identify the interval with a gap in sounds.

Dichotic Digit Test: Repeat back numbers heard in each ear.

Spatial Separation Sentence Test: Understand speech in noisy conditions.

10. Outcome Measures

Temporal Processing: Adaptive Test for Temporal Resolution (Threshold in msec).

Binaural Integration: Dichotic Digit Test (Score - Double correct score and Single correct score).

Speech in Noise: Spatial Separation Sentence Test (SNR in dB).

11. Ethical considerations and methods to address issues: Approvals will be obtained from IRC,IEC along with CTRI approval. Subject participants will be well explained about the study and a consent would be obtained on volunteering to participate. Information that are required for the study would be kept confidential (name, phone number etc.) and would only be reviewed by the authorized personnel. The data would not be made available to another individual unless a permission specifying the need of the data is given in writing. All information will be stored and safeguarded ensuring transparency and trust throughout the process.

12. Review of literature: Several researches have proven the protective benefits of hearing from consuming omega-3 fatty acids. Regular consumption of fishes and higher consumption of PUFAs and have been demonstrated to significantly reduce hearing loss. Dietary intake of PUFAs could significantly reduce or delay, the advancement of age-related hearing loss by improving cochlear blood flow. Changing the nutritional diet of elderly people could decrease hearing loss progression. A study done on the risks of disabling hearing impairment due to diet intake reported that consuming more saturated fatty acids above 10% of energy intake would increase the possibility of hearing loss. Women under 60 years of age had a decreased possibility of hearing loss when they consumed more polyunsaturated fatty acids (PUFAs) and derived more than 15% of their energy from PUFAs, whereas men did not show any such correlation. A study found that a regular fish diet can prevent hearing impairment in women. Consuming fish twice a week reduces the risk of hearing impairment, and more long-chain omega -3 polyunsaturated fats can lower the likelihood of hearing loss.