None listed
Conditions
Brief summary
Project is exploring a new approach in the prevention and treatment of type 1 diabetes by suppressing a newly discovered type of iron-dependent cell death called ferroptosis, through the use of specific natural compound sulforaphane, present in cruciferous vegetables, such as broccoli. We aimed to examine whether such an approach will preserving the functional population of pancreatic ß-cells, the key cells for insulin production, as well as the function of cells in tissues affected by diabetes.
Interventions
The clinical study will be conducted as a randomized, double-blind, placebo-controlled trial. Sixty adult male participants (18-65 years old) will be recruited at the Clinic of Endocrinology, Diabetes and Metabolic Disease, University Clinical Center of Serbia, Belgrade. The study inclusion criteria will be as follows: confirmed diabetes type 1 (T1D) for less than 15 years, intensive insulin substitution or subcutaneous insulin infusion therapy, body mass index less than 35 kg/m² and informed
The clinical study will be conducted as a randomized, double-blind, placebo-controlled trial. Sixty adult male participants (18-65 years old) will be recruited at the Clinic of Endocrinology, Diabetes and Metabolic Disease, University Clinical Center of Serbia, Belgrade. The study inclusion criteria will be as follows: confirmed diabetes type 1 (T1D) for less than 15 years, intensive insulin substitution or subcutaneous insulin infusion therapy, body mass index less than 35 kg/m² and informed consent signed. The participants from the intervention group will take orally 36 mg (83 µM) of activated sulforaphane precursor, glucoraphanin (sulforaphane glucosinolate) daily for three months. Intervention capsules contain 18 mg glucoraphanin from broccoli seeds and 2.8 µM myrosinase (activating enzyme). The placebo group will take capsules with microcrystalline cellulose (placebo). All participants will be asked to take 2 capsules after breakfast, Taking capsules will be monitored once per week through phone interviews. Participants will be asked to bring back non-used capsules, and study compliance will be assessed by capsules accountability,
Sponsors
The Science Fund of the Republic of Serbia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
The study inclusion criteria will be as follows: confirmed T1D for less or equal 15 years, intensive insulin substitution or subcutaneous insulin infusion therapy, body mass index (BMI) less than35 kg/m² and informed consent signed.
Exclusion criteria
Exclusion criteria will be: impaired thyroid function with inadequate therapy, severe diseases (cancer, cardiac, neurological)
Outcome results
None listed