An interventional study of Diet experiment in Acne Cystic and Diet, Healthy, sponsored by Igdir University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Igdir University · Not applicable, Interventional, and Prevention
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.
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.
Igdir University is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Patients taking medication will be given a diet in accordance with the basic Mediterranean diet rules.
Dietary Supplement: Diet experiment
Patients taking medication will be given a diet containing \<200 mg of cholesterol per day, based on personal wishes.
Dietary Supplement: Diet experiment
They will not take a diet, and take only the medication.
For the isotretinoin users
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.
Time frame: 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.
Time frame: 4 weeks, 8 weeks, 12 weeks
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.
Time frame: 4 weeks, 8 weeks, 12 weeks
Personal Information-Check Form
With this form, the meal frequencies, medication doses, and physical activities of the participants will be recorded for later use in comparisons.
Time frame: 4 weeks, 8 weeks, 12 weeks
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Igdir University