The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-23

Study Completion Date

2025-06-30

Brief Summary

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The goal of this clinical trial is to investigate The effects of an anti-inflammatory diet with or without curcumin supplementation on anthropometric measurements, concentrations of thyroid hormones, anti-TPO, and systemic inflammation in plasma and NFK-B in peripheral blood mononuclear cells in patients with Hashimoto.

The main questions it aims to answer are:

1. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in anthropometric measurements (weight, body mass index, BMI, waist circumference, waist-to-hip ratio) in patients with Hashimoto's disease?
2. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in the serum concentration of thyroid hormones (T3, T4, TSH) in patients with Hashimoto's disease?
3. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the change of Anti-TPO concentration in patients with Hashimoto's disease?
4. Does prescribing an anti-inflammatory diet with or without curcumin supplementation significantly affect the changes in systemic inflammation indicators (hs-CRP, IL-6) in plasma and NF-κB in peripheral blood mononuclear cells in patients with Hashimoto's disease?

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Detailed Description

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Conditions

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Thyroid Diseases Hypothyroidism Hashimoto Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study subjects are Hashimoto's patients who, if they wish to participate in this research, a written consent form will be obtained from the patients at the beginning of the study. The patients will be classified according to age and sex. Then, using Stratified Block Randomization, patients will be placed in one of two intervention or placebo groups. The intervention will last 12 weeks, and the anti-inflammatory diet will be personalized based on each person's calorie intake. Patients will be asked to take one tablet with cold water daily (morning, noon, and night with the main meals). Also, the curcumin placebo in size, shape, color, appearance, smell, and dispensing cans of the drug will be similar to the curcumin supplement.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Before the start of the study, the set of cans containing the relevant capsules will be coded as A and B by someone other than the researcher so that the researcher does not know the type of capsule received by the patients. The cans containing the relevant capsules will be delivered to the patients on a monthly basis, and they will be asked to take one tablet with cold water every day (morning, noon, and night with the main meals). Also, the curcumin placebo will be similar to the curcumin supplement in terms of size, shape, color, appearance, smell, and drug distribution cans.

Study Groups

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The group receiving anti-inflammatory diet with curcumin supplement

Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg curcumin capsules along with the main meals of breakfast, lunch, and dinner.

Group Type EXPERIMENTAL

curcumin

Intervention Type DIETARY_SUPPLEMENT

Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner

Anti-inflammatory diet

Intervention Type BEHAVIORAL

The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.

Group receiving anti-inflammatory regimen with curcumin placebo

Implementation of an anti-inflammatory diet along with the daily consumption of three 500 mg placebo capsules of curcumin (microcrystalline cellulose) and the main meals of breakfast, lunch, and dinner.

Group Type PLACEBO_COMPARATOR

Anti-inflammatory diet

Intervention Type BEHAVIORAL

The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.

Interventions

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curcumin

Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner

Intervention Type DIETARY_SUPPLEMENT

Anti-inflammatory diet

The anti-inflammatory diet will be personalized based on each person's calorie intake in five meals. Achieving the goals of an anti-inflammatory diet by consuming only one type of food or following its principles in one meal is impossible and must be implemented consistently and regularly in a meal plan.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Having Hashimoto's thyroiditis Willingness to cooperate Body mass index between 35 and 18.5 TSH less than ten and without clinical symptoms Not taking levothyroxine tablets

Exclusion Criteria

Pregnancy and breastfeeding kidney Diseases Follow non-routine weight loss diets for three months before the start of the study × Taking slimming and fat-burning drugs, fiber powder Mineral, vegetable, and fiber vitamin supplements

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No