Effect of Different Diets on Isotretinoin Users to Serum Lipid Levels

NCT06250673 | Completed

• 1 other identifier: UUyar1
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Cystic; Diet, Healthy

Keywords

Mediternian Diet Low Cholesterol Diet Isotretinoin

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (1)

• Food Consumption Frequency Form

  4 weeks, 8 weeks, 12 weeks

Other Outcomes (1)

• Personal Information-Check Form

  4 weeks, 8 weeks, 12 weeks

Study Arms (3)

Mediterranean Diet Group

EXPERIMENTAL

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

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.

Dietary Supplement: Diet experiment

Control Group

NO INTERVENTION

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

Interventions

Diet experiment DIETARY_SUPPLEMENT

For the isotretinoin users

Low Cholesterol Group; Mediterranean Diet Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Igdir University: lead
• Okan University: collaborator

Study Sites (1)

Iğdır Dr. Nevruz Erez State Hospital

Iğdır, Merkez, 76004, Turkey (Türkiye)

Location

Study Officials

• Umut Uyar

  Igdir University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 46 people, 16-16-14.

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: February 9, 2024
• Study Start: November 1, 2023
• Primary Completion: February 8, 2024
• Study Completion: May 28, 2024
• Last Updated: May 1, 2025

Record last verified: 2024-02

Locations

TU (1)