Thyroid DiseasesNCT05975866
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
A study testing curcumin and Anti-inflammatory diet in people with Thyroid Diseases and Hypothyroidism, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease
- What is being tested?
- curcumin and Anti-inflammatory diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 23 Sep 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Golbon Sohrab
Tehran, National Nutrition and Food Technology Research Institute
About this study
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?
- Conditions
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease
- Being tested
- curcumin, Anti-inflammatory diet
- Keywords
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease, Anti-inflammatory diet, Curcumin
- Medical subject headings
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDietary supplement
Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner
Anti-inflammatory dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Anti-inflammatory diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL6
Interleukin 6
Measured: 3 month
hs-Crp
high-sensitivity C-reactive protein
Measured: 3 month
NF-KB
Nuclear factor kappa-light-chain-enhancer of activated B cells
Measured: 3 month
Anti-tpo
antithyroperoxidase
Measured: 3 month
T4
Thyroxine
Measured: 3 month
T3
Triiodothyronine
Measured: 3 month
TSH
Thyroid-stimulating hormone
Measured: 3 month
waist circumference
waist circumference in Centimeter
Measured: 3 month
hip circumference
hip circumference in Centimeter
Measured: 3 month
waist to hip ratio
an Anthropometric index
Measured: 3 month
BMI
Body Mass Index - Anthropometric index
Measured: 3 month
Total Cholestrol
serum lipid profile
Measured: 3 month
TG
Triglyceride - serum lipid profile
Measured: 3 month
Hb
hemoglobin - Blood test
Measured: 3 month
hematocrit
Blood test
Measured: 3 month
LDL
low-density lipoprotein
Measured: 3 month
HDL
high-density lipoprotein
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start23 Sep 2023 (estimated)
- Primary completion19 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975866
- Sponsor's protocol ID
- 0410359181
- Status last verified
- Jul 2023
- First submitted
- 27 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42016234Bourbour 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.
PubMed 41329567
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05975866
- Acronym / sponsor ID
- 0410359181
- Conditions
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease
- Keywords
- Thyroid Diseases, Hypothyroidism, Hashimoto Disease, Anti-inflammatory diet, Curcumin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 23 Sep 2023 (estimated)
- Primary completion
- 19 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The group receiving anti-inflammatory diet with curcumin supplement | Experimental | Dietary Supplement: curcumin, Behavioral: Anti-inflammatory dietImplementation 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 dietImplementation 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcuminDaily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner | Dietary supplement | The group receiving anti-inflammatory diet with curcumin supplement |
| Anti-inflammatory dietThe 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. | Behavioural | Group receiving anti-inflammatory regimen with curcumin placebo, The group receiving anti-inflammatory diet with curcumin supplement |
Primary outcome
IL6
Time frame: 3 month
Interleukin 6
hs-Crp
Time frame: 3 month
high-sensitivity C-reactive protein
NF-KB
Time frame: 3 month
Nuclear factor kappa-light-chain-enhancer of activated B cells
Anti-tpo
Time frame: 3 month
antithyroperoxidase
T4
Time frame: 3 month
Thyroxine
T3
Time frame: 3 month
Triiodothyronine
TSH
Time frame: 3 month
Thyroid-stimulating hormone
waist circumference
Time frame: 3 month
waist circumference in Centimeter
hip circumference
Time frame: 3 month
hip circumference in Centimeter
waist to hip ratio
Time frame: 3 month
an Anthropometric index
BMI
Time frame: 3 month
Body Mass Index - Anthropometric index
Total Cholestrol
Time frame: 3 month
serum lipid profile
TG
Time frame: 3 month
Triglyceride - serum lipid profile
Hb
Time frame: 3 month
hemoglobin - Blood test
hematocrit
Time frame: 3 month
Blood test
LDL
Time frame: 3 month
low-density lipoprotein
HDL
Time frame: 3 month
high-density lipoprotein
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Derived from this study: PubMed 42016234Bourbour 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.
- Derived from this study: PubMed 41329567Bourbour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curcumin and Anti-inflammatory diet in people with Thyroid Diseases and Hypothyroidism, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL6 (time frame: 3 month). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05975866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.