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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05975866
• Other study ID #: 0410359181
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 23, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: July 2023
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2025
• Est. primary completion date: April 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hashimoto Disease
• Hypothyroidism
• Inflammation
• Thyroid Diseases

Intervention

Dietary Supplement:
• curcumin
Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner

Behavioral:
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Golbon Sohrab	Tehran	National Nutrition And Food Technology Research Institute

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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