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临床试验/NCT07164079
NCT07164079已完成不适用

Effect of Dietary Supplementation of Rubus Sanctus (Wild Blackberry) Root Extract on Disease Prognosis in Graves' Disease: A Randomized Controlled Clinical Trial

Betul Uner2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2024年12月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Effect of Rubus sanctus root on thyroid hormones

研究概览

简要总结

The aim of this single-blind, randomized, experimental study was to investigate the effect of Rubus sanctus root extract, which has antioxidant properties, added to the routine diet of patients with Graves' disease on the prognosis of the disease.

The study sample included patients who presented to the Endocrinology and Metabolic Diseases Outpatient Clinic of Muğla Sıtkı Koçman University Training and Research Hospital and were diagnosed with Graves' disease or developed a relapse after necessary examinations. Cohen's standardized effect size was used. Accordingly, the required sample size for the study was determined to be 42, using an alpha value of 0.05, an effect size of 0.80, and a theoretical power of 80%. The study planned to include a minimum of 42 participants: 21 intervention participants and 21 controls.

Patients assigned to the control group were asked to continue their routine diet, adhere to any necessary pharmacological treatments, and consume a placebo tea for the planned 8-week intervention period. Routine monthly examinations will be collected, and anthropometric measurements will be repeated at the end of 8 weeks.

Patients assigned to the experimental group will be asked to continue their routine diet for 8 weeks, comply with any required pharmacological treatments, and consume Rubus sanctus root extract, produced by aqueous extraction and lyophilization, with active ingredient (phenolic compound) determined by LC-MS-MS, and prepared as a tea in 5-g packets. Anthropometric measurements will be repeated at the end of 8 weeks.

H0: Rubus sanctus root extract supplemented to the diet has no effect on Graves' disease.

H1: Rubus sanctus root extract supplemented to the diet has an effect on Graves' disease.

详细描述

Humanity has fought many battles for survival. One of the most important of these battles is the fight against disease. The imbalance between free radicals and antioxidants in the body leads to oxidative stress, which in turn contributes to a range of diseases, including autoimmune diseases. To avoid diseases that may arise from oxidative stress, it is recommended that individuals ensure they consume adequate amounts of antioxidants in their routine diet, avoid harmful habits that increase oxidant production, such as smoking and alcohol, exercise regularly, and get adequate sleep.

Since ancient times, various parts of plants have been used to treat illnesses. The blackberry plant, with its fruit, leaves, stem, and root, is considered one of these plant products. The blackberry plant belongs to the Rubus genus of the Rosaceae family. Rubus sanctus is the most common species in the Muğla region. Wild blackberries are strong, thorny shrubs that grow primarily in forests, vacant lots, and along roadsides. The fruit is usually black and edible. It is reported in the literature that extracts of the aboveground parts of the blackberry plant are used to heal infected insect bites and skin wounds, teas obtained from the plant roots are used in the autoimmune disease rheumatoid arthritis and to relieve pain, and extracts obtained from the leaves and roots are used in diarrhea due to their antimicrobial effects.

The beneficial health effects of blackberry root extract are attributed to its polyphenol content. The polyphenols found in blackberry root extract include the phenolic acids gallic acid, the flavonoids quercetin, apigenin, and catechins, the tannins ellagic acid, the terpenes triterpenes, including betulinic acid, which has anti-carcinogenic effects, and α-tocopherol.

Mice studies have determined that different doses of blackberry root extract have anti-inflammatory properties, promote wound healing and skin symptoms, and exhibit neuropharmacological effects. Another study reported that blackberry root extract exhibits antibacterial activity against Staphylococcus aureus. An in vitro study demonstrated that blackberry root (Rubus sanctus) extract possesses potential anticancer, antioxidant, anti-lipase, and α-amylase inhibitory activity. The study concluded that blackberry root extract may be a promising resource for applications in the functional food, nutraceutical, and pharmaceutical industries.

Autoimmune thyroid diseases are defined as a group of diseases in which the immune system targets and attacks the thyroid gland. These diseases include Hashimoto's thyroiditis and Graves' disease, and have two extreme clinical presentations. Both conditions are characterized by thyroid dysfunction, but they differ in their pathogenesis and clinical symptoms. There is evidence in the literature that the COVID-19 pandemic has led to an increase in autoimmune thyroid diseases. The global prevalence of autoimmune thyroid diseases varies depending on geographic, ethnic, and environmental factors. However, these diseases are considered a significant health problem worldwide and are, on average, 5-7 times more common in women. The prevalence of Graves' disease ranges from 0.5% to 1.0%.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a new diagnosis of Graves' disease or those with a relapse of Graves' disease
  • Patients aged 18-65
  • A score of 80 or higher on the Health Eating Index (HEI)

排除标准

  • Having received treatment for the disease within the last 6 months
  • Having another chronic and/or autoimmune disease
  • Being pregnant or lactating

研究组 & 干预措施

Blackberry root group

Experimental

Patients in the intervention group will receive a Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks.

干预措施: blackberry root (Dietary Supplement)

Black Tea group

Placebo Comparator

Patients with Graves' disease assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks.

干预措施: black tea (Dietary Supplement)

结局指标

主要结局

Effect of Rubus sanctus root on thyroid hormones

时间窗: 8-week intervention

It will be determined whether the use of Rubus sanctus in Graves' patients causes changes in the blood parameters of the thyroid hormones TSH, T4, and T3 associated with the disease.

Effect of Rubus sanctus use on disease-related autoimmune markers

时间窗: 8-week intervention

It will be determined whether the use of Rubus sanctus in Graves' disease patients causes changes in blood parameters such as anti-TPO, anti-TG, and TSH receptor antibodies, which are autoimmune markers associated with the disease.

Determination of anatomical and structural changes in the thyroid gland due to the use of Rubus sanctus

时间窗: 8-week intervention

The effect of Rubus sanctus use on thyroid parenchymal echogenicity and thyroid volume in Graves' disease will be determined by thyroid ultrasound.

次要结局

未报告次要终点

研究者

发起方
Betul Uner
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Betul Uner

Lecturer, MSc

Muğla Sıtkı Koçman University

研究点 (2)

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