<b>Evaluating the Effect of Celery on Hashimoto’s Thyroiditis: A Randomized Trial Study Design</b>

<b>Trial Design:</b><br>Celery (<i>Apium graveolens </i>L.), a potent antioxidant high in D-limonene and nitrates, is documented to alter neuro-immune-endocrine mechanisms through various intracellular processes in thyrocytes, hepatocytes, and gastrointestinal bacterial signaling. Stress-related immune factors implicated in autoimmune thyroid diseases include reactive oxygen and nitrogen species, elevated cytokines, and autoantibody activity. Case reports indicate celery powder (CP) provokes hyperthyroidism. If CP can induce a hyperthyroid state, it may manage Hashimoto’s thyroiditis (HT). This study aims to develop a trial design to investigate the effects of celery, D-limonene, and nitrates, on thyroid function.<br><b>Methods:</b><br>The proposed study is a randomized-comparative, single-blind, 3-arm, parallel-pilot study using 39 HT patients, randomized into three groups of thirteen. Group 1 (GCS) participants will drink 1-2 cups (120-240 mL) of pureed celery stalk (5-10 g), Group 2 (GCP) participants will drink a comparison solution of 1-2 cups of concentrated citrus peel tea (2-3 tsp dried), Group 3 (GS) participants will drink a placebo solution of starch (0.25 g) mixed with 1 cup of water. Primary endpoints and laboratory tests will be tested every 30 days to include measuring thyroxine (T4), triiodothyronine (T3), thyroid stimulating hormone (TSH), thyroid peroxidase (TPO), thyroglobulin (Tg), and lipid, inflammatory, and anthropometric biomarkers.<br><b>Results:</b><br>Researchers anticipate observing increases in blood pressure (11 mm Hg in systolic and 5 mm Hg in diastolic) and improvements in biomarkers. This study aims to be the first randomized trial to explore the effects of celery on thyroid function. The findings will provide practitioners with clear nutritional protocols for managing HT patients.