Rubus Sanctus (Wild Blackberry) Root Extract as a Dietary Supplement for Graves' Disease

Summary

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.

Conditions

• Graves Disease (Basedow's Disease)

Interventions

DIETARY_SUPPLEMENT

blackberry root

Patients in the intervention group will receive a Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks. The tea will be packaged as 5 grams of Rubus Sanctus root and steeped in 200 ml of water at 80°C for 5 minutes. Participants in the intervention group will receive the Rubus Sanctus root tea along with the necessary equipment (a 200 ml beaker and thermometer). Measurements of TSH, T4, T3, anti-TPO, anti-TG, TSH receptor antibodies, liver function tests, thyroid parenchymal echogenicity, and thyroid volume will be taken at the Endocrinology and Metabolic Diseases Clinic of Muğla Training and Research Hospital before and after the study.

DIETARY_SUPPLEMENT

black tea

Patients with Graves' disease assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks. Black tea is a product consumed almost daily in Turkish society. Black tea will be prepared in 5-g doses and steeped in 200 ml of water at 80°C for 5 minutes. Participants in the control group will be provided with black tea bags along with the necessary equipment (a 200 ml beaker and thermometer). TSH, T4, T3, anti-TPO, anti-TG, TSH receptor antibody, liver function tests, thyroid parenchymal echogenicity, and thyroid volume will be obtained before and after the study at the Endocrinology and Metabolic Diseases Clinic of Muğla Training and Research Hospital.

Sponsors & Collaborators

• Betul Uner

  lead OTHER

Principal Investigators

• Betül Üner Yılmaz, Lecturer · https://www.mu.edu.tr/tr/personel/betuluner

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2026-03-31

Completion

2026-06-30

Countries

• Turkey (Türkiye)

Study Locations