Unlocking Hope: Development of India's First Indigenous Ketogenic Dietary Formula for Pediatric Epilepsy Care

Epilepsy affects millions of children worldwide, with 30% of cases being resistant to conventional antiseizure medications, necessitating alternative treatments. The ketogenic diet, a high-fat, low-carbohydrate regimen, is effective in drug-resistant epilepsy, but access to affordable, culturally appropriate ketogenic products remains a challenge in developing countries. This study aims to develop the first indigenous ketogenic formula for children with drug-resistant epilepsy, using locally sourced, culturally appropriate ingredients.

A ketogenic formula was developed using coconut milk powder, almond flour, soya flour, rice flakes, Bengal gram dal, and coconut oil, ensuring adaptability to ketogenic ratios (1:1 to 4:1). Organoleptic evaluation was conducted with neurologists, dietitians, parents, and children to assess taste, texture, and acceptability. Microbial safety and nutritional analysis ensured compliance with dietary requirements.

The developed ketogenic formula demonstrated high acceptability across all groups, with neurologists, dietitians, parents, and children giving hedonic scores of 8.8, 8.6, 8.4, and 8.2, respectively. Microbial testing confirmed safety, with no pathogenic bacteria detected. Nutritional analysis confirmed adherence to dietary standards with an energy content 564.99 kcal, fat content 37.99 g, protein content 9.1 g, and carbohydrates 46.67 g. The developed ketogenic formula also maintained its quality and safety throughout a 6-month shelf life study without use of any preservatives.

This study successfully developed a culturally appropriate, cost-effective ketogenic formula, addressing barriers to epilepsy management in resource-limited settings. Its high acceptability, safety, and adaptability suggest its potential for widespread use. Future clinical trials will assess its long-term efficacy and broader applicability.