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. (PHYTASE)

University of Thessaly

Status: Enrolling

Conditions: Anemia; Colitis Ulcerative; Multiple Sclerosis; Hypertension (HTN); IBD

Treatments: Dietary Supplement: Dietary supplement intervention Goodphyte IB Defense; Dietary Supplement: Dietary supplement intervention Goodphyte Immunity

Study type: Interventional

Funder types: Other

Identifiers

NCT07380022

92/25.6.2025

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Dietary supplement intervention Goodphyte IB Defense

Other group

Description:

50 Participants will receive dietary supplement Goodphyte IB Defense

Treatment:

Dietary Supplement: Dietary supplement intervention Goodphyte IB Defense

Dietary supplement intervention Goodphyte Immunity

Other group

Description:

50 Participants will receive dietary supplement Goodphyte Immunity

Treatment:

Dietary Supplement: Dietary supplement intervention Goodphyte Immunity