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Recruiting NCT07380022

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.

No phase Interventional IBD Hypertension (HTN) Multiple Sclerosis Anemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dietary supplement intervention Goodphyte IB Defense, Dietary supplement intervention Goodphyte Immunity.
Who it may be relevant to
Registry conditions: IBD, Hypertension (HTN), Multiple Sclerosis, Anemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Greece
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Dietary supplement Dietary supplement intervention Goodphyte IB Defense
    Participants will receive orally Goodphyte IB Defense at a dose of four capsules per day for a duration of two weeks.
  • Dietary supplement Dietary supplement intervention Goodphyte Immunity
    Participants will receive orally Goodphyte IB Immunity at a dose of four capsules per day for a duration of two weeks.

Primary outcome measures

  • Acceptability of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity using an acceptability questionnaire [Time frame: 2 weeks (immediately after completion of the 2-week intervention)]
  • Adherence to the Intervention [Time frame: From enrollment to the end of treatment at 2 weeks]
Secondary outcome measures (12)
  • Changes in serum iron levels (μg/dL) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in serum zinc levels (μg/dL) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in ferritin (ng/mL) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in C-reactive protein (CRP) (mg/L) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in fecal calprotectin (µg/g) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in Erythrocyte Sedimentation Rate (ESR) (mm) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Changes in Quality of Life (QoL) using WHOQOL-BREF questionnaire [Time frame: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]
  • Changes in Quality of Life (QoL) using EQ-5D-5L questionnaire [Time frame: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]
  • Changes in fatigue levels using the Chalder Fatigue Scale (CFQ) questionnaire [Time frame: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]
  • Body Mass Index (BMI) using measured body weight and height (kg/m²) [Time frame: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
  • Harvey-Bradshaw Index (HBI) Score [Time frame: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]
  • Mayo Score for Ulcerative Colitis [Time frame: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Greece · 1 center
  • School of Physical Education, Sport Science and Dietetics — Trikala

Identifiers

NCT: NCT07380022 · 92/25.6.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗