Acceptability, Adherence, and Impact on the Bioavailability of Iron and Zinc of the Dietary Supplements Goodphyte IB Defense and Goodphyte Immunity in Adults With Chronic Diseases.
Recruiting · NCT07380022 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Thessaly
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The primary objective of the present postdoctoral research is to evaluate the acceptability and adherence of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity, in adult individuals with chronic diseases, namely Idiopathic Inflammatory Bowel Diseases (IIBD)-that is, Crohn's disease (CD) or Ulcerative Colitis (UC)-Arterial Hypertension (AH), Anemia (AN), or Multiple Sclerosis (MS). Secondarily, this study will investigate potential changes in iron and zinc absorption following phytase supplementation in these individuals and, consequently, possible changes in their quality of life.
Who can take part
Inclusion criteria
- Crohn's disease: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.
- Ulcerative colitis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.
- Hypertension: Patients with systolic blood pressure of 130-139 mmHg or diastolic blood pressure of 80-89 mmHg, who maintain blood pressure within these ranges through lifestyle modifications, without active symptoms (e.g., headaches, dizziness), and not receiving antihypertensive medication.
- Anemia: Patients with hemoglobin \<12 g/dL, serum iron \<40 μg/dL, and ferritin \<15 ng/mL for women, and hemoglobin \<13 g/dL, serum iron \<40 μg/dL, and ferritin \<30 ng/mL for men. Absence of severe clinical consequences. Presence of fatigue, weakness, or dizziness, which is usually manageable.
- Multiple sclerosis: Patients in remission, with a stable type of pharmacological treatment over the past 3 months and a stable dosage during the last month.
Exclusion criteria
- Pregnancy or breastfeeding
- Current use of antibiotics or antibiotic use within the past month
- Current use of other probiotic, prebiotic, or synbiotic supplements
- Current use of iron and/or zinc supplements
- Change in the type of therapeutic regimen (pharmacotherapy) within the past three months
- Change in the dosage of the therapeutic regimen (pharmacotherapy) within the past month
- Renal or hepatic disease
- Inability to provide informed consent (including individuals \<18 years of age)
- Insufficient understanding of the Greek language
Where it is running
3 locations listed.
- School of Physical Education, Sport Science and Dietetics - Trikala, Thessaly, Greece
- School of Physical Education, Sport Science and Dietetics - Trikala, Thessaly, Greece
- School of Physical Education, Sport Science and Dietetics - Trikala, Thessaly, Greece