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 | Unknown DMC

• 1 other identifier: 0410359181
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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?

Conditions

Thyroid Diseases; Hypothyroidism; Hashimoto Disease

Keywords

Thyroid Diseases; Hypothyroidism; Hashimoto Disease; Anti-inflammatory diet; Curcumin

Outcome Measures

Primary Outcomes (17)

• IL6

  Interleukin 6

  3 month

• hs-Crp

  high-sensitivity C-reactive protein

  3 month

• NF-KB

  Nuclear factor kappa-light-chain-enhancer of activated B cells

  3 month

• Anti-tpo

  antithyroperoxidase

  3 month

• T4

  Thyroxine

  3 month

• T3

  Triiodothyronine

  3 month

• TSH

  Thyroid-stimulating hormone

  3 month

• waist circumference

  waist circumference in Centimeter

  3 month

• hip circumference

  hip circumference in Centimeter

  3 month

• waist to hip ratio

  an Anthropometric index

  3 month

• BMI

  Body Mass Index - Anthropometric index

  3 month

• Total Cholestrol

  serum lipid profile

  3 month

• TG

  Triglyceride - serum lipid profile

  3 month

• Hb

  hemoglobin - Blood test

  3 month

• hematocrit

  Blood test

  3 month

• LDL

  low-density lipoprotein

  3 month

• HDL

  high-density lipoprotein

  3 month

Study Arms (2)

The group receiving anti-inflammatory diet with curcumin supplement

EXPERIMENTAL

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.

Dietary Supplement: curcumin; Behavioral: Anti-inflammatory diet

Group receiving anti-inflammatory regimen with curcumin placebo

PLACEBO COMPARATOR

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.

Behavioral: Anti-inflammatory diet

Interventions

curcumin DIETARY_SUPPLEMENT

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

The group receiving anti-inflammatory diet with curcumin supplement

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.

Group receiving anti-inflammatory regimen with curcumin placebo; The group receiving anti-inflammatory diet with curcumin supplement

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

Study Sites (1)

Golbon Sohrab

Tehran, National Nutrition and Food Technology Research Institute, Iran

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Thyroid Diseases; Hypothyroidism; Hashimoto Disease

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Thyroiditis, Autoimmune; Thyroiditis; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PHD of nutrition s science

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: September 23, 2023
• Primary Completion: April 19, 2025
• Study Completion: June 30, 2025
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)