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Study on the Safety Efficacy and Tolerability of a Low Glycemic Index Diet for People with Drug-Resistant Epilepsy

Safety Efficacy and Tolerability of Low Glycemic Index Diet treatment in Persons with Drug Resistant Epilepsy: Randomized Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/089262
Enrollment
70
Registered
2025-06-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G409- Epilepsy, unspecified

Interventions

Intervention1: Low glycemic index treatment (LGIT): LGIT is a variant of the ketogenic diet with increased palatability and flexibility, featuring a fat-to-carbohydrate and protein ratio of approximat

Sponsors

Prof. (Dr.) Manjari Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients aged between 18 to 55 years with a confirmed clinical diagnosis of Drug Resistant Epilepsy (DRE) and receiving treatment in the Neurology OPD of AIIMS New Delhi, having a seizure frequency of more than 2 per month for at least 6 months, and willing to begin with Low Glycemic Index Therapy (LGIT).

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Patients not willing to participate, those with learning difficulties or vision/hearing impairments, inability to read English or Hindi script, pregnant and lactating mothers, presence of metabolic syndrome, surgically remediable cause for DRE, clinical features suggestive of in-born errors of metabolism, suspicion of metabolic disorder or systemic diseases including diabetes mellitus, cardiovascular disease, or metabolic disorders such as carnitine disease or beta oxidation defects, history of prior myocardial infarction, refusal to give consent, or those who have tried LGIT or similar dietary interventions in the past.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with more than 50% seizure frequency reduction at 3 months after initiation of diet therapy.Timepoint: Baseline and at 3 months

Secondary

MeasureTime frame
o Rate and characteristics of short term (3 months) adverse events in LGIT. o Rate of withdrawal from the LGIT diet during the study period and reasons for withdrawal. o To assess change in parameters of Quality of life and behavior at 3 months in both the groups using semi-structured self-designed questionnaire.Timepoint: Baseline and at 3 months

Countries

India

Contacts

Public ContactProf Dr Manjari Tripathi

Department of Neurology, All India Institute of Medical Sciences, New Delhi

manjari.tripathi@gmail.com8929919736

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026