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The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested:
Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).
The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low glycemic index diet treatment | Experimental | Children with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low glycemic index diet treatment | Other | This study was a non-randomized, single centre, pre/post-intervention study. A low glycemic index diet was prescribed by a dietician for 3 months. LGID treatment consisted of 10% (40-60 g) low glycaemic index (glycaemic index <50) carbohydrate, 20-30% protein and 60-70% lipid |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in seizure frequency | Seizure diary was kept by parents to records seizure frequency and severity | Baseline and Month 3 |
| Concentration of antioxidant and oxidant status | Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS)) | Baseline and Month 3 |
| Concentration of Paraoxonase Enzyme Activity | Measurement of Paraoxonase Enzyme Activity (PON-1) | Baseline and Month 3 |
| Concentration of Malondialdehyde (MDA) | Measurement of Malondialdehyde (MDA) | Baseline and Month 3 |
| Changes in quality of life | "Pediatric Inventory of Quality of Life" was applied to assess health-related quality of life. A higher score corresponds to a higher health-related quality of life. The score ranges from 0 to 100 | Baseline and Month 3 |
| Changes in psychosocial problems | Psychosocial problems were assessed by the "Strengths and Difficulties Questionnaire".The questionnaire includes 25 questions, some of which question positive and some of which question negative behavioral characteristics. These questions are grouped under 5 sub-headings. These are behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems and social behaviors. Each heading is evaluated in itself with scores that range from 0 to 10 and the sum of the first four headings gives the "total difficulty score". While high scores in social behavior reflect the individual's strengths in the social domain, high scores in the other four domains (behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems) reflect that the problem areas are severe. |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of glucose | Measurement of glucose | Baseline and Month 3 |
| Concentration of insulin | Measurement of insulin | Baseline and Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gamze Yurtdaş Depboylu | Çiğli | İ̇zmi̇r | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline and Month 3 |
| Changes in depression level | Depression status was assessed by the "Children's Depression Scale".Scores that can be obtained from the scale can vary between 0-54. The cut-off point of the depression scale for children is 19, and high scores indicate a high risk of depression. | Baseline and Month 3 |
| Concentration of liver function tests | Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST) | Baseline and Month 3 |
| Changes in lipid profile | Measurement of total cholesterol (mg/dl), LDL cholesterol (mg/dl), HDL cholesterol (mg/dl), serum triglyceride (mg/dl) | Baseline and Month 3 |
| D010549 |
| Personal Satisfaction |
| D001519 | Behavior |