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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- LDL
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
LDL
时间窗: 3 month
low-density lipoprotein
waist circumference
时间窗: 3 month
waist circumference in Centimeter
HDL
时间窗: 3 month
high-density lipoprotein
T4
时间窗: 3 month
Thyroxine
TSH
时间窗: 3 month
Thyroid-stimulating hormone
waist to hip ratio
时间窗: 3 month
an Anthropometric index
IL6
时间窗: 3 month
Interleukin 6
NF-KB
时间窗: 3 month
Nuclear factor kappa-light-chain-enhancer of activated B cells
Anti-tpo
时间窗: 3 month
antithyroperoxidase
Hb
时间窗: 3 month
hemoglobin - Blood test
hs-Crp
时间窗: 3 month
high-sensitivity C-reactive protein
hip circumference
时间窗: 3 month
hip circumference in Centimeter
Total Cholestrol
时间窗: 3 month
serum lipid profile
TG
时间窗: 3 month
Triglyceride - serum lipid profile
T3
时间窗: 3 month
Triiodothyronine
BMI
时间窗: 3 month
Body Mass Index - Anthropometric index
hematocrit
时间窗: 3 month
Blood test
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
MD-PHD of nutrition s science
National Nutrition and Food Technology Institute