Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-23 @ 6:31 AM
Study NCT ID:
NCT05975866
Status:
UNKNOWN
Last Update Posted:
2023-08-04
First Post:
2023-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D007037', 'term': 'Hypothyroidism'}, {'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-09-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IL6', 'timeFrame': '3 month', 'description': 'Interleukin 6'}, {'measure': 'hs-Crp', 'timeFrame': '3 month', 'description': 'high-sensitivity C-reactive protein'}, {'measure': 'NF-KB', 'timeFrame': '3 month', 'description': 'Nuclear factor kappa-light-chain-enhancer of activated B cells'}, {'measure': 'Anti-tpo', 'timeFrame': '3 month', 'description': 'antithyroperoxidase'}, {'measure': 'T4', 'timeFrame': '3 month', 'description': 'Thyroxine'}, {'measure': 'T3', 'timeFrame': '3 month', 'description': 'Triiodothyronine'}, {'measure': 'TSH', 'timeFrame': '3 month', 'description': 'Thyroid-stimulating hormone'}, {'measure': 'waist circumference', 'timeFrame': '3 month', 'description': 'waist circumference in Centimeter'}, {'measure': 'hip circumference', 'timeFrame': '3 month', 'description': 'hip circumference in Centimeter'}, {'measure': 'waist to hip ratio', 'timeFrame': '3 month', 'description': 'an Anthropometric index'}, {'measure': 'BMI', 'timeFrame': '3 month', 'description': 'Body Mass Index - Anthropometric index'}, {'measure': 'Total Cholestrol', 'timeFrame': '3 month', 'description': 'serum lipid profile'}, {'measure': 'TG', 'timeFrame': '3 month', 'description': 'Triglyceride - serum lipid profile'}, {'measure': 'Hb', 'timeFrame': '3 month', 'description': 'hemoglobin - Blood test'}, {'measure': 'hematocrit', 'timeFrame': '3 month', 'description': 'Blood test'}, {'measure': 'LDL', 'timeFrame': '3 month', 'description': 'low-density lipoprotein'}, {'measure': 'HDL', 'timeFrame': '3 month', 'description': 'high-density lipoprotein'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Thyroid Diseases', 'Hypothyroidism', 'Hashimoto Disease', 'Anti-inflammatory diet', 'Curcumin'], 'conditions': ['Thyroid Diseases', 'Hypothyroidism', 'Hashimoto Disease']}, 'referencesModule': {'references': [{'pmid': '41329567', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe main questions it aims to answer are:\n\n1. 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?\n2. 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?\n3. 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?\n4. 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?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nHaving 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\n\nExclusion Criteria:\n\nPregnancy 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"}, 'identificationModule': {'nctId': 'NCT05975866', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'National Nutrition and Food Technology Institute'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '0410359181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The group receiving anti-inflammatory diet with curcumin supplement', '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.', 'interventionNames': ['Dietary Supplement: curcumin', 'Behavioral: Anti-inflammatory diet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group receiving anti-inflammatory regimen with curcumin placebo', '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.', 'interventionNames': ['Behavioral: Anti-inflammatory diet']}], 'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Daily consumption of three 500 mg curcumin capsules with breakfast, lunch, and dinner', 'armGroupLabels': ['The group receiving anti-inflammatory diet with curcumin supplement']}, {'name': 'Anti-inflammatory diet', 'type': 'BEHAVIORAL', '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.", 'armGroupLabels': ['Group receiving anti-inflammatory regimen with curcumin placebo', 'The group receiving anti-inflammatory diet with curcumin supplement']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'National Nutrition and Food Technology Research Institute', 'country': 'Iran', 'facility': 'Golbon Sohrab', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Nutrition and Food Technology Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD-PHD of nutrition s science', 'investigatorFullName': 'Dr Azita Hekmatdoost', 'investigatorAffiliation': 'National Nutrition and Food Technology Institute'}}}}