Trying two phytase supplements to improve iron and zinc absorption and ease of use in adults with chronic conditions
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.
This project will test whether two phytase dietary supplements are easy to take and help increase iron and zinc absorption in adults with chronic conditions like IBD, hypertension, anemia, or multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Trikala, Thessaly) |
| Trial ID | NCT07380022 on ClinicalTrials.gov |
What this trial studies
This interventional postdoctoral research gives adult participants one of two microbial phytase-containing supplements (Goodphyte IB Defense or Goodphyte Immunity) and tracks how acceptable the products are and how well people stick to taking them. The study measures iron and zinc bioavailability changes after supplementation and records any changes in quality of life. Eligible participants include adults with Crohn's disease or ulcerative colitis in remission with stable treatment, adults with mild hypertension controlled by lifestyle, adults meeting lab criteria for iron-deficiency anemia, or adults with multiple sclerosis in remission. All visits take place at the School of Physical Education, Sport Science and Dietetics in Trikala, Thessaly, and participants will follow the supplement regimen and scheduled assessments there.
Who should consider this trial
Good fit: Adults with Crohn's disease or ulcerative colitis in remission with stable therapy, adults with mild lifestyle-controlled hypertension (SBP 130-139 or DBP 80-89), adults meeting the specified laboratory criteria for iron-deficiency anemia, or adults with multiple sclerosis in remission are ideal candidates.
Not a fit: People with active or unstable disease, rapidly changing medication regimens, severe anemia or other severe clinical consequences, those taking antihypertensive medications for blood pressure control, or those unable to attend site visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, these supplements could offer an easy-to-take way to improve iron and zinc absorption and help reduce mineral deficiencies in people with chronic conditions.
How similar studies have performed: Some nutrition research suggests phytase can increase iron and zinc bioavailability in foods, but using phytase as a daily supplement in adults with chronic diseases is relatively novel and not widely proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Trikala, Thessaly
- School of Physical Education, Sport Science and Dietetics — Trikala, Thessaly, Greece (Recruiting)
Study contacts
- Study coordinator: VAIOS SVOLOS, PhD
- Email: vaiossvolos@gmail.com
- Phone: +306989953903
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.