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临床试验/NCT07048821
NCT07048821已完成不适用

The Impact of Mediterranean Diet on Patients With Hashimoto Thyroiditis

Sherihan AboElyazed Mohamed Khalil2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Changes in the serum level of free T3

研究概览

简要总结

Hashimoto's thyroiditis (HT) is an autoimmune disease affecting the thyroid gland and is one of the most common causes of hypothyroidism. Eating habits may affect the risk of several inflammatory and immune diseases, such as HT. The current knowledge of the diet in HT is insufficient. The Mediterranean diet (MD) is an anti-inflammatory diet characterized by frequent consumption of olive oil, unrefined cereals, fresh or dried fruit and vegetables, moderate amounts of fish, dairy, and meat, and many condiments and spices. It is rich in nutrients and bioactives, which have the potential to offer anti-inflammatory aspects.

详细描述

The investigators aimed to assess the impact of the Mediterranean diet on patients with Hashimoto thyroiditis using the following outcomes:

Primary outcomes: Anti-TPO antibodies, Anti-Thyroglobulin antibodies, TSH, T3, T4 Secondary outcomes: BMI, Lipid profile, Symptoms of hypothyroidism

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with symptoms of hypothyroidism (hypothyroid/euthyroid)
  • Positive anti-thyroid antibodies (anti-TPO/anti-TG).

排除标准

  • Pregnant or lactating females
  • Age below 20 years and above 50 years
  • presence of any other medical disorder

结局指标

主要结局

Changes in the serum level of free T3

时间窗: after 3 months of dietary modification

pg/ml

Changes in the serum level of free T4

时间窗: after 3 months of dietary modification

ng/dl

Changes in the serum level of anti-TPO and Anti-TG antibodies

时间窗: after 3 months of dietary modification

IU/ml

Changes in the serum level of TSH

时间窗: after 3 months of dietary modification

uIU/ml

次要结局

  • changes in serum level of total cholesterol, triglyceride, low-density lipoprotein, high-density lipoprotein(after 3 months of intervention)
  • Symptoms of hypothyroidism(after 3 months of intervention)
  • changes in BMI(after 3 months of intervention)

研究者

发起方
Sherihan AboElyazed Mohamed Khalil
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherihan AboElyazed Mohamed Khalil

Lecturer of Endocrinology and Internal Medicine Faculty of Medicine, Ain Shams University Cairo, Egypt

Ain Shams University

研究点 (2)

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