Ketogenic DietNCT06432231
Effects of Low Glycemic Index Diet in Children With Drug-resistant Epilepsy
A study testing Low glycemic index diet treatment in people with Ketogenic Diet and Drug Resistant Epilepsy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Ketogenic Diet, Drug Resistant Epilepsy, Oxidative Stress
- What is being tested?
- Low glycemic index diet treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Aug 2022to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between the ages of 4-18,
- being diagnosed with drug-resistant epilepsy,
- having more than one seizure per week,
- not having followed a ketogenic diet before.
- willing to come for regular follow up
Who cannot join
- children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
- non-compliance with the diet recommended by the patient and/or parents
- enteral tube or parenteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy
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:
- LGID reduces seizure frequency in children with drug-resistant epilepsy.
- LGID improves oxidative parameters in children with drug-resistant epilepsy
- LGID improves quality of life and mental health in children with drug-resistant epilepsy
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).
Read the detailed description
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.
- Conditions
- Ketogenic Diet, Drug Resistant Epilepsy, Oxidative Stress, Quality of Life, Psychological Health
- Being tested
- Low glycemic index diet treatment
- Medical subject headings
- Drug Resistant Epilepsy, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low glycemic index diet treatmentOther
Also called LGID
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
| Study group | Role | What they receive |
|---|---|---|
| Low glycemic index diet treatment | Experimental | Children with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months. Receives: Other: Low glycemic index diet treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in seizure frequency
Seizure diary was kept by parents to records seizure frequency and severity
Measured: Baseline and Month 3
Concentration of antioxidant and oxidant status
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))
Measured: Baseline and Month 3
Concentration of Paraoxonase Enzyme Activity
Measurement of Paraoxonase Enzyme Activity (PON-1)
Measured: Baseline and Month 3
Concentration of Malondialdehyde (MDA)
Measurement of Malondialdehyde (MDA)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and Month 3
Secondary outcomes (4)
Concentration of glucose
Measurement of glucose
Measured: Baseline and Month 3
Concentration of insulin
Measurement of insulin
Measured: Baseline and Month 3
Concentration of liver function tests
Measurement of Alanine transaminase (ALT) and Aspartate transaminase (AST)
Measured: 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)
Measured: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start28 Aug 2022
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Yurtdaş Depboylu, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432231
- Sponsor's protocol ID
- 2022-GAP-SABF-0052
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy
- ClinicalTrials.gov ID
- NCT06432231
- Acronym / sponsor ID
- 2022-GAP-SABF-0052
- Conditions
- Ketogenic Diet, Drug Resistant Epilepsy, Oxidative Stress, Quality of Life, Psychological Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- LGID reduces seizure frequency in children with drug-resistant epilepsy.
- LGID improves oxidative parameters in children with drug-resistant epilepsy
- LGID improves quality of life and mental health in children with drug-resistant epilepsy
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low glycemic index diet treatment | Experimental | Other: Low glycemic index diet treatmentChildren with drug-resistant epilepsy were treated with a low glycemic index diet for 3 months. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being between the ages of 4-18,
- being diagnosed with drug-resistant epilepsy,
- having more than one seizure per week,
- not having followed a ketogenic diet before.
- willing to come for regular follow up
Key exclusion criteria (3 listed)
- children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
- non-compliance with the diet recommended by the patient and/or parents
- enteral tube or parenteral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low glycemic index diet treatmentAlso: LGIDThis 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 | Other | Low glycemic index diet treatment |
Primary outcome
Changes in seizure frequency
Time frame: Baseline and Month 3
Seizure diary was kept by parents to records seizure frequency and severity
Concentration of antioxidant and oxidant status
Time frame: Baseline and Month 3
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))
Concentration of Paraoxonase Enzyme Activity
Time frame: Baseline and Month 3
Measurement of Paraoxonase Enzyme Activity (PON-1)
Concentration of Malondialdehyde (MDA)
Time frame: Baseline and Month 3
Measurement of Malondialdehyde (MDA)
Changes in quality of life
Time frame: Baseline and Month 3
"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
Changes in psychosocial problems
Time frame: Baseline and Month 3
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.
Changes in depression level
Time frame: Baseline and Month 3
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.
4 secondary outcomes
Concentration of glucose
Time frame: Baseline and Month 3
Concentration of insulin
Time frame: Baseline and Month 3
Concentration of liver function tests
Time frame: Baseline and Month 3
Changes in lipid profile
Time frame: Baseline and Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low glycemic index diet treatment in people with Ketogenic Diet and Drug Resistant Epilepsy, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in seizure frequency (time frame: Baseline and Month 3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.