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Randomized Controlled Trial
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Evaluation of Qualitative Dietary Protocol (Diet4Hashi) Application in Dietary Counseling in Hashimoto Thyroiditis: Study Protocol of a Randomized Controlled Trial

Randomized Controlled Trial

Evaluation of Qualitative Dietary Protocol (Diet4Hashi) Application in Dietary Counseling in Hashimoto Thyroiditis: Study Protocol of a Randomized Controlled Trial

Natalia Wojtas et al. Int J Environ Res Public Health.


The current state of knowledge related to diet in Hashimoto thyroiditis (HT) is far from satisfactory, as many HT subjects experience several disorders and report reduced quality of life. There are three aims of the study: (1) to develop a qualitative dietary protocol (QDP; 'Diet4Hashi') as a simple, graphic-text tool dedicated to TH subjects, (2) to evaluate the use of the QDP in dietetic counseling compared to conventional dietetic counseling (CDC) in HT women, and (3) to assess the impact of both the QDP and the CDC on the diet quality, quality of life, adiposity, and metabolic parameters of HT women. The QDP is based on subject self-monitoring supported with a graphic-text tool to help them in food selection and adequate food frequency consumption, while the CDC on oral explanation and printed sample menus were provided by a dietician. The QDP contains two lists: (A) foods recommended for consumption and (B) foods with limited consumption, along with indicated consumption frequency per day/week/month. Both approaches include the same dietary recommendations for HT extracted from the literature but differ in subject-dietician cooperation. To summarize the evidence regarding dietary recommendations in HT, the PubMed, Embase, and Cochrane Library databases (to March 2019) and the bibliographies of key articles were searched. The study is designed as a dietary intervention lasting six months in two parallel groups: experimental and control. In the experimental group, the QDP will be applied, while in the control group, the CDC will be applied. In total, the study will include a baseline of 100 women with diagnosed HT. The subjects will be randomly allocated into the experimental/control groups (50/50). Data related to diet quality and other lifestyle factors, nutrition knowledge, quality of life, thyroid function, body composition, blood pressure, serum fasting glucose, and lipid profile at baseline and after a six-month follow-up will be collected. This study was conducted to develop a dietary protocol (Diet4Hashi) that is easy to follow for HT subjects, and it will contribute to providing valuable data that are useful to dieticians and physicians. It is anticipated that this graphic-text qualitative dietary protocol, by improving food selection and diet quality, may reduce adiposity and improve metabolic parameters and the quality of life of HT women.

Keywords: Hashimoto; adiposity; diet quality; dietary intervention; dietary protocol; dietetic counseling; hypothyroidism; metabolic parameters; obesity; quality of life.

Conflict of interest statement

The authors declare no conflict of interest.


Figure 1
Figure 1
Sample collection chart.

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