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

July 27, 2023 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • National Nutrition And Food Technology Research Institute
      • Tehran, National Nutrition And Food Technology Research Institute, Iran, Islamic Republic of
        • Golbon Sohrab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 23, 2023

Primary Completion (Estimated)

April 19, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0410359181

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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