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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

Primary Purpose

Thyroid Diseases, Hypothyroidism, Hashimoto Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
curcumin
Anti-inflammatory diet
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Diseases focused on measuring Thyroid Diseases, Hypothyroidism, Hashimoto Disease, Anti-inflammatory diet, Curcumin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Golbon Sohrab

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The group receiving anti-inflammatory diet with curcumin supplement

Group receiving anti-inflammatory regimen with curcumin placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
July 27, 2023
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05975866
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 23, 2023 (Anticipated)
Primary Completion Date
April 19, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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: 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? 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? 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? 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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Diseases, Hypothyroidism, Hashimoto Disease
Keywords
Thyroid Diseases, Hypothyroidism, Hashimoto Disease, Anti-inflammatory diet, Curcumin

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The group receiving anti-inflammatory diet with curcumin supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
Group receiving anti-inflammatory regimen with curcumin placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
curcumin
Intervention Description
Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner
Intervention Type
Behavioral
Intervention Name(s)
Anti-inflammatory diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
IL6
Description
Interleukin 6
Time Frame
3 month
Title
hs-Crp
Description
high-sensitivity C-reactive protein
Time Frame
3 month
Title
NF-KB
Description
Nuclear factor kappa-light-chain-enhancer of activated B cells
Time Frame
3 month
Title
Anti-tpo
Description
antithyroperoxidase
Time Frame
3 month
Title
T4
Description
Thyroxine
Time Frame
3 month
Title
T3
Description
Triiodothyronine
Time Frame
3 month
Title
TSH
Description
Thyroid-stimulating hormone
Time Frame
3 month
Title
waist circumference
Description
waist circumference in Centimeter
Time Frame
3 month
Title
hip circumference
Description
hip circumference in Centimeter
Time Frame
3 month
Title
waist to hip ratio
Description
an Anthropometric index
Time Frame
3 month
Title
BMI
Description
Body Mass Index - Anthropometric index
Time Frame
3 month
Title
Total Cholestrol
Description
serum lipid profile
Time Frame
3 month
Title
TG
Description
Triglyceride - serum lipid profile
Time Frame
3 month
Title
Hb
Description
hemoglobin - Blood test
Time Frame
3 month
Title
hematocrit
Description
Blood test
Time Frame
3 month
Title
LDL
Description
low-density lipoprotein
Time Frame
3 month
Title
HDL
Description
high-density lipoprotein
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Golbon Sohrab
City
Tehran
State/Province
National Nutrition And Food Technology Research Institute
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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