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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Turkey
Muğla Sıtkı Koçman University/Muğla Training and Research Hospital Endocrine and Metabolic Diseases Polyclinic
RECRUITING
Muğla
Contact Information
Primary
Betül Üner Yılmaz
betul.uner@gmail.com
+905077138298
Time Frame
Start Date: 2024-12-12
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 42
Treatments
Experimental: Blackberry root group
Patients in the intervention group will receive a Rubus Sanctus root extract, which they will consume with breakfast for 8 weeks.
Placebo_comparator: Black Tea group
Patients with Graves' disease assigned to the control group will be asked to consume black tea (Camellia sinensis) with their breakfast for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Betul Uner

This content was sourced from clinicaltrials.gov