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.

CompletedNot a drug-phase studyMS (type not specified)NCT07380022

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Dietary supplement intervention Goodphyte IB Defense
  • Dietary supplement intervention Goodphyte Immunity

What it measured

Main measures

  • Acceptability of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity using an acceptability questionnaire

    2 weeks (immediately after completion of the 2-week intervention)

    SafetyFeasibility
  • Adherence to the Intervention

    From enrollment to the end of treatment at 2 weeks

    Quality of life (reported by participants)

Other measures (17)

  • Changes in serum iron levels (μg/dL)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

  • Changes in serum zinc levels (μg/dL)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

  • Changes in ferritin (ng/mL)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

  • Changes in C-reactive protein (CRP) (mg/L)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

  • Changes in fecal calprotectin (µg/g)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

    Bladder, bowel and sexual function
  • Changes in Erythrocyte Sedimentation Rate (ESR) (mm)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

  • Changes in Quality of Life (QoL) using WHOQOL-BREF questionnaire

    Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)

    Quality of life (reported by participants)
  • Changes in Quality of Life (QoL) using EQ-5D-5L questionnaire

    Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)

    Quality of life (reported by participants)
  • Changes in fatigue levels using the Chalder Fatigue Scale (CFQ) questionnaire

    Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)

    Fatigue
  • Body Mass Index (BMI) using measured body weight and height (kg/m²)

    Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)

    Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jul 2025

    2. Main results due

      Feb 2026

    3. Finished

      Feb 2026

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