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

NCT05975866 — Not applicable, Unknown, 60 participants, National Nutrition and Food Technology Institute

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Registry	NCT05975866
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	60 (Estimated)
Sponsor	National Nutrition and Food Technology Institute (Other)
Conditions	Thyroid Diseases, Hypothyroidism, Hashimoto Disease
Interventions	curcumin, Anti-inflammatory diet (Dietary supplement, behavioral)
Dates	start 2023-09-23 (estimated), primary completion 2025-04-19 (estimated), completion 2025-06-30 (estimated), first posted 2023-08-04, last updated 2023-08-04
Locations	1 site in Iran

-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?

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+Arms and interventions

Arm	Type	Interventions	Description
The group receiving anti-inflammatory diet with curcumin supplement	Experimental	Dietary Supplement: curcumin; Behavioral: 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.
Group receiving anti-inflammatory regimen with curcumin placebo	Placebo comparator	Behavioral: 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.

curcumin (Dietary supplement): Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner
Anti-inflammatory diet (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.

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 20 Years to 70 Years

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

+Locations (1)

Facility	City	Country	Status
Golbon Sohrab	Tehran, National Nutrition and Food Technology Research Institute	Iran

+Publications

Results publication: Bourbour F, Mahdavi B, Naghshi N, Yari Z, Hosseini SM, Kalbasi S, Sohrab G. The Additive Effects of Curcumin Supplementation in Addition to an Anti-Inflammatory Diet on Inflammatory Indices in Patients With Hashimoto's Thyroiditis (HT): A Double Blind Randomized Controlled Clinical Trial. Food Sci Nutr. 2026 Mar 11;14(3):e71572. doi: 10.1002/fsn3.71572. eCollection 2026 Mar. PMID 42016234
Results publication: Bourbour F, Mahdavi B, Naghshi N, Yari Z, Hosseini SM, Kalbasi S, Sohrab G. The Combined Effects of an Anti-Inflammatory Diet and Curcumin Supplementation on Thyroid Function and Lipid Profile in Patients With Hashimoto's Thyroiditis: A Double Blind Randomised Clinical Trial. Endocrinol Diabetes Metab. 2026 Jan;9(1):e70138. doi: 10.1002/edm2.70138. PMID 41329567