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

Not Applicable

Not yet recruiting

• Conditions: Hypothyroidism; Thyroid Diseases; Hashimoto Disease
• Interventions: Behavioral: Anti-inflammatory diet; Dietary Supplement: curcumin

• Registration Number: NCT05975866
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study First Posted: 2023-08-04
• Last Update Posted: 2023-08-04
• Study Start: 2023-09-23
• Primary Completion: 2025-04-19
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group receiving anti-inflammatory regimen with curcumin placebo	Anti-inflammatory diet	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.
The group receiving anti-inflammatory diet with curcumin supplement	curcumin	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.
The group receiving anti-inflammatory diet with curcumin supplement	Anti-inflammatory diet	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.

Primary Outcome Measures

Name	Time	Method
LDL	3 month	low-density lipoprotein
waist circumference	3 month	waist circumference in Centimeter
HDL	3 month	high-density lipoprotein
T4	3 month	Thyroxine
TSH	3 month	Thyroid-stimulating hormone
waist to hip ratio	3 month	an Anthropometric index
IL6	3 month	Interleukin 6
NF-KB	3 month	Nuclear factor kappa-light-chain-enhancer of activated B cells
Anti-tpo	3 month	antithyroperoxidase
Hb	3 month	hemoglobin - Blood test
hip circumference	3 month	hip circumference in Centimeter
hs-Crp	3 month	high-sensitivity C-reactive protein
Total Cholestrol	3 month	serum lipid profile
TG	3 month	Triglyceride - serum lipid profile
T3	3 month	Triiodothyronine
BMI	3 month	Body Mass Index - Anthropometric index
hematocrit	3 month	Blood test

Trial Locations

Locations (1)

Golbon Sohrab; 🇮🇷 Tehran, National Nutrition And Food Technology Research Institute, Iran, Islamic Republic of