Effect of Different Diets on Isotretinoin Users to Serum Lipid Levels

NCT ID: NCT06250673

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-05-28

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Mediterranean Diet Group

Patients taking medication will be given a diet in accordance with the basic Mediterranean diet rules.

Group Type: EXPERIMENTAL

Diet experiment

Intervention Type: DIETARY_SUPPLEMENT

For the isotretinoin users

Low Cholesterol Group

Patients taking medication will be given a diet containing \<200 mg of cholesterol per day, based on personal wishes.

Group Type: EXPERIMENTAL

Diet experiment

Intervention Type: DIETARY_SUPPLEMENT

For the isotretinoin users

Control Group

They will not take a diet, and take only the medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diet experiment

For the isotretinoin users

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Okan University

OTHER

Sponsor Role: collaborator

Igdir University

OTHER

Sponsor Role: lead

Responsible Party

Umut Uyar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umut Uyar

Role: STUDY_DIRECTOR

Igdir University

Locations

Iğdır Dr. Nevruz Erez State Hospital

Iğdır, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

UUyar1

Identifier Type: -

Identifier Source: org_study_id