Acne CysticNCT06250673
Effect of Different Diets on Isotretinoin Users to Serum Lipid Levels
A study testing Diet experiment in people with Acne Cystic and Diet, Healthy, run by Igdir University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to prevent secondary hyperlipidemia, which may occur due to isotretinoin used in the treatment of severe acne, with diet. There will be three different groups and followed for 12 weeks. Groups will be; Mediterranean Diet, Low Cholesterol Diet (<200 mg/day) and the Control Group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Cystic, Diet, Healthy
- What is being tested?
- Diet experiment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 28 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be treated for acne and must be new to oral isotretinoin treatment, Aged must be 18 - 65 years old, Body Mass Index must be between 18-24.99 kg/m2, LDL Cholesterol must be <130 mg/dL, Triglyceride must be <150 mg/dL.
Who cannot join
- Cardiovascular diseases, Kidney diseases, Eating disorders, Hyperlipidemia, Insulin resistance, Metabolic diseases, Diabetes, And who used the drugs for the treatment of these diseases, BMI <18 kg/m2, >25 kg/m2 Aged <18 and >65 will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Iğdır Dr. Nevruz Erez State Hospital
Iğdır, Merkez, 76004
About this study
Official title: The Effect of the Mediterranean Diet and Low Cholesterol Diet on Serum Lipid Levels in Individuals Receiving Isotretinoin Treatment
This research was planned to prevent secondary hyperlipidemia, which may occur due to isotretinoin used in the treatment of severe acne, with diet. There will be three different groups and followed for 12 weeks. Groups will be; Mediterranean Diet, Low Cholesterol Diet (<200 mg/day) and the Control Group.
Read the detailed description
Isotretinoin has been officially used to treat severe cystic acne since the 1980s. The drug is a retinoic acid derivative and works by reducing the size of the sebaceous glands and sebum production. Thanks to this effect, the lipid profile on the skin surface changes and the bacterial skin flora decreases.
The drug also has a side effect of increasing blood lipids, causing secondary hyperlipidemia. This research examines the effects of low cholesterol diet and Mediterranean diet on blood lipids, which are implemented to prevent the increase of blood lipids.
The research was designed as an experimental intervention research and will conducted at Nevruz Erez State Hospital Skin and Venereology Polyclinics between November 2023 and April 2024, with volunteers who meet the research criteria.
H0: Secondary hyperlipidemia due to isotretinoin use cannot be prevented by diet.
H1: Secondary hyperlipidemia due to isotretinoin use can be prevented by diet. People who volunteer to participate in the research will be informed in detail about the research with the Informed Consent Form and then will be grouped by the list method. At the beginning of the research, the Personal Information Form, the Mediterranean Diet Adherence Scale and the Food Consumption Frequency form prepared by the researcher will be applied to all patients who volunteer to participate in the research. The results of Biochemistry and Hemogram tests performed by the doctor will be recorded.
During the research, the blood findings (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride, ALT, AST and Hemogram) of the patients in each group will be checked monthly by the Skin and Venereology Polyclinic Physician who follows their treatment, and the patients' isotretinoin doses will be completely adjusted by the doctor. No intervention other than diet will be made by the researcher.
Sample size of the study (n); Effect size (d) = 0.94, significance level (α) = 0.05, power of the test (1-β) = 80% were entered into the Gpower program and calculated as 32(n) for two groups. This research will be conducted with three different groups, in this case, it is planned to complete the research on a total of at least 48 patients, namely the Mediterranean Diet Group (n1) = 16, the Low Cholesterol Diet Group (n2) = 16 and the Control Group (n3) = 16.
Considering that the research period is 12 weeks, 25% more people will be recruited for each group in case the patients leave the study or are excluded from the research. In this situation; Mediterranean Diet Group (n1) = 20 people, Low Cholesterol Diet Group (n2) = 20 people, Control Group (n3) = 20 people, Total Sample Size (n) = 60 people. The total research duration for all groups participating in the research is planned to be 12 weeks.
- Conditions
- Acne Cystic, Diet, Healthy
- Being tested
- Diet experiment
- Keywords
- Mediternian Diet Low Cholesterol Diet Isotretinoin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet experimentDietary supplement
For the isotretinoin users
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean Diet Group | Experimental | Patients taking medication will be given a diet in accordance with the basic Mediterranean diet rules. Receives: Dietary Supplement: Diet experiment |
| Low Cholesterol Group | Experimental | Patients taking medication will be given a diet containing <200 mg of cholesterol per day, based on personal wishes. Receives: Dietary Supplement: Diet experiment |
| Control Group | No intervention | They will not take a diet, and take only the medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Tests
Participants ' blood lipids will be monitored since the research aims to prevent seconder hyperlipidemia. HDL, LDL, Total Cholesterol, Triglyceride, ALT and AST values will be checked monthly.
Measured: 4 weeks, 8 weeks, 12 weeks
Mediterranean Diet Adherence Scale
Within the scope of the research, data will be evaluated with the Mediterranean Diet Adherence Scale, Food Consumption Frequency, Personal Information-Check Form and patients' biochemical test results.
The validity and reliability study of the Mediterranean Diet Adherence Scale was conducted for Turkey in 2020 by Pehlivanoğlu et al. The scale consists of 14 questions and the answers to these questions are scored between 0 and 1 by the researcher. If the total score obtained from the scale is ≤5, it means low compliance with the Mediterranean diet, if it is between 6-9 points, it means medium compliance with the Mediterranean diet, and if the score is ≥10, it means high compliance with the Mediterranean diet.
Measured: 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (1)
Food Consumption Frequency Form
Within the scope of the research, data will be evaluated with the Mediterranean Diet Adherence Scale, Food Consumption Frequency, Personal Information-Check Form and patients' biochemical test results.
With the help of the Food Consumption Frequency Form which was created by the researcher, patients' compliance with their diet and how much cholesterol and fat they consume will be checked and recorded monthly.
Measured: 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Nov 2023
- Primary completion8 Feb 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne CysticStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 46 people, 16-16-14.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Collaborators
- Okan University
- Responsible party
- Principal investigator, Umut Uyar, Igdir University
- Investigators
- Umut Uyar, Study director, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250673
- Sponsor's protocol ID
- UUyar1
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Mediterranean Diet and Low Cholesterol Diet on Serum Lipid Levels in Individuals Receiving Isotretinoin Treatment
- ClinicalTrials.gov ID
- NCT06250673
- Acronym / sponsor ID
- UUyar1
- Conditions
- Acne Cystic, Diet, Healthy
- Keywords
- Mediternian Diet Low Cholesterol Diet Isotretinoin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Collaborators
- Okan University
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 9 Feb 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.
This research was planned to prevent secondary hyperlipidemia, which may occur due to isotretinoin used in the treatment of severe acne, with diet. There will be three different groups and followed for 12 weeks. Groups will be; Mediterranean Diet, Low Cholesterol Diet (<200 mg/day) and the Control Group.
Detailed description
Isotretinoin has been officially used to treat severe cystic acne since the 1980s. The drug is a retinoic acid derivative and works by reducing the size of the sebaceous glands and sebum production. Thanks to this effect, the lipid profile on the skin surface changes and the bacterial skin flora decreases.
The drug also has a side effect of increasing blood lipids, causing secondary hyperlipidemia. This research examines the effects of low cholesterol diet and Mediterranean diet on blood lipids, which are implemented to prevent the increase of blood lipids.
The research was designed as an experimental intervention research and will conducted at Nevruz Erez State Hospital Skin and Venereology Polyclinics between November 2023 and April 2024, with volunteers who meet the research criteria.
H0: Secondary hyperlipidemia due to isotretinoin use cannot be prevented by diet.
H1: Secondary hyperlipidemia due to isotretinoin use can be prevented by diet. People who volunteer to participate in the research will be informed in detail about the research with the Informed Consent Form and then will be grouped by the list method. At the beginning of the research, the Personal Information Form, the Mediterranean Diet Adherence Scale and the Food Consumption Frequency form prepared by the researcher will be applied to all patients who volunteer to participate in the research. The results of Biochemistry and Hemogram tests performed by the doctor will be recorded.
During the research, the blood findings (Total Cholesterol, HDL-Cholesterol, LDL-Cholesterol, Triglyceride, ALT, AST and Hemogram) of the patients in each group will be checked monthly by the Skin and Venereology Polyclinic Physician who follows their treatment, and the patients' isotretinoin doses will be completely adjusted by the doctor. No intervention other than diet will be made by the researcher.
Sample size of the study (n); Effect size (d) = 0.94, significance level (α) = 0.05, power of the test (1-β) = 80% were entered into the Gpower program and calculated as 32(n) for two groups. This research will be conducted with three different groups, in this case, it is planned to complete the research on a total of at least 48 patients, namely the Mediterranean Diet Group (n1) = 16, the Low Cholesterol Diet Group (n2) = 16 and the Control Group (n3) = 16.
Considering that the research period is 12 weeks, 25% more people will be recruited for each group in case the patients leave the study or are excluded from the research. In this situation; Mediterranean Diet Group (n1) = 20 people, Low Cholesterol Diet Group (n2) = 20 people, Control Group (n3) = 20 people, Total Sample Size (n) = 60 people. The total research duration for all groups participating in the research is planned to be 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A total of 46 people, 16-16-14.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean Diet Group | Experimental | Dietary Supplement: Diet experimentPatients taking medication will be given a diet in accordance with the basic Mediterranean diet rules. |
| Low Cholesterol Group | Experimental | Dietary Supplement: Diet experimentPatients taking medication will be given a diet containing <200 mg of cholesterol per day, based on personal wishes. |
| Control Group | No intervention | –They will not take a diet, and take only the medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be treated for acne and must be new to oral isotretinoin treatment, Aged must be 18 - 65 years old, Body Mass Index must be between 18-24.99 kg/m2, LDL Cholesterol must be <130 mg/dL, Triglyceride must be <150 mg/dL.
Key exclusion criteria (1 listed)
- Cardiovascular diseases, Kidney diseases, Eating disorders, Hyperlipidemia, Insulin resistance, Metabolic diseases, Diabetes, And who used the drugs for the treatment of these diseases, BMI <18 kg/m2, >25 kg/m2 Aged <18 and >65 will not be included in the study.
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 |
|---|---|---|
| Diet experimentFor the isotretinoin users | Dietary supplement | Low Cholesterol Group, Mediterranean Diet Group |
Primary outcome
Biochemical Tests
Time frame: 4 weeks, 8 weeks, 12 weeks
Participants ' blood lipids will be monitored since the research aims to prevent seconder hyperlipidemia. HDL, LDL, Total Cholesterol, Triglyceride, ALT and AST values will be checked monthly.
Mediterranean Diet Adherence Scale
Time frame: 4 weeks, 8 weeks, 12 weeks
Within the scope of the research, data will be evaluated with the Mediterranean Diet Adherence Scale, Food Consumption Frequency, Personal Information-Check Form and patients' biochemical test results. The validity and reliability study of the Mediterranean Diet Adherence Scale was conducted for Turkey in 2020 by Pehlivanoğlu et al. The scale consists of 14 questions and the answers to these questions are scored between 0 and 1 by the researcher. If the total score obtained from the scale is ≤5, it means low compliance with the Mediterranean diet, if it is between 6-9 points, it means medium compliance with the Mediterranean diet, and if the score is ≥10, it means high compliance with the Mediterranean diet.
1 secondary outcome
Food Consumption Frequency Form
Time frame: 4 weeks, 8 weeks, 12 weeks
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 1 May 2025.
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.
Umut Uyar study director
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet experiment in people with Acne Cystic and Diet, Healthy, run by Igdir 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 1 inclusion and 1 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 1 May 2025. 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?
Biochemical Tests (time frame: 4 weeks, 8 weeks, 12 weeks). The study lists 2 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 1 May 2025.