Effects of calorie-restricted diet on health state and intestinal flora in Hashimoto's thyroiditis patients: Study protocol for a randomized controlled trial.

IF 1.3 4区 医学 Q4 NUTRITION & DIETETICS
Qingling Huang, Kaixin Pan, Yuxuan Zhang, Songtao Li, Jiaomei Li
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Abstract

Background and objectives: Hashimoto's thyroiditis (HT) is an autoimmune disease, characterized by abnormal elevation in thyroid peroxidase antibody and/or thyroglobulin antibody. In recent decades, HT disease has become more and more widespread. Patients always report multiple symptoms, even though their thyroid hormone levels are kept in normal ranges. However, no treatment exists to effectively reduce the levels of thyroid antibodies. Our study aims to determine whether calorie-restricted diet is helpful in improving health of HT patients.

Methods and study design: This is a 3-month randomized controlled trial. HT patients will be randomized into a calorie-restricted (CR) group or a calorie-unrestricted control group. All the participants will be instructed to consume a diet that includes a combination of 45-55% calories from carbohydrates, 20-30% from fats, and 15-25% from proteins, according to current Chinese Dietary Guidelines. Participants in CR group need to limit their calories intake equal to their basal energy expenditure, which means that their daily caloric intake will be limited by about 20-30%.

Results: The study population is planned to be 66 HT patients aged 18 to 65 years. The primary outcome is change of thyroid antibody levels from baseline. Secondary outcomes include the changes of non-hypothyroid symptoms scores, thyroid function indexes, morphology of thyroid, T lymphocyte subpopulations, inflammatory biomarkers and lipids from baseline to 12 weeks.

Conclusions: This trial will have implications for nutrition treatment policy in regard to thyroid antibodies control, immune dysfunction and related non-hypothyroid symptoms improvement among HT patients.

卡路里限制饮食对桥本氏甲状腺炎患者健康状况和肠道菌群的影响:随机对照试验研究方案。
背景和目的:桥本氏甲状腺炎(HT)是一种自身免疫性疾病,以甲状腺过氧化物酶抗体和/或甲状腺球蛋白抗体异常升高为特征。近几十年来,桥本氏甲状腺炎的发病率越来越高。尽管患者的甲状腺激素水平保持在正常范围内,但他们总是表现出多种症状。然而,目前还没有有效降低甲状腺抗体水平的治疗方法。我们的研究旨在确定卡路里限制饮食是否有助于改善甲状腺肿大患者的健康状况:这是一项为期 3 个月的随机对照试验。高血压患者将被随机分为卡路里限制(CR)组或卡路里不受限制对照组。根据现行的中国膳食指南,所有参与者的饮食中碳水化合物占45%-55%,脂肪占20%-30%,蛋白质占15%-25%。CR组的参与者需要将热量摄入限制在与基础能量消耗相等的水平上,这意味着他们每天的热量摄入将被限制约20%-30%:研究对象计划为 66 名甲亢患者,年龄在 18 岁至 65 岁之间。主要结果是甲状腺抗体水平与基线相比的变化。次要结果包括非甲状腺功能减退症状评分、甲状腺功能指数、甲状腺形态、T淋巴细胞亚群、炎症生物标志物和血脂从基线到12周的变化:这项试验将对甲状腺抗体控制、免疫功能障碍和甲状腺功能亢进患者相关非甲减症状改善方面的营养治疗政策产生影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
2.50
自引率
7.70%
发文量
58
审稿时长
6-12 weeks
期刊介绍: The aims of the Asia Pacific Journal of Clinical Nutrition (APJCN) are to publish high quality clinical nutrition relevant research findings which can build the capacity of clinical nutritionists in the region and enhance the practice of human nutrition and related disciplines for health promotion and disease prevention. APJCN will publish original research reports, reviews, short communications and case reports. News, book reviews and other items will also be included. The acceptance criteria for all papers are the quality and originality of the research and its significance to our readership. Except where otherwise stated, manuscripts are peer-reviewed by at least two anonymous reviewers and the Editor. The Editorial Board reserves the right to refuse any material for publication and advises that authors should retain copies of submitted manuscripts and correspondence as material cannot be returned. Final acceptance or rejection rests with the Editorial Board
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