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.

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Acceptability of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity using an acceptability questionnaire [Срок оценки: 2 weeks (immediately after completion of the 2-week intervention)]
• Adherence to the Intervention [Срок оценки: From enrollment to the end of treatment at 2 weeks]

Вторичные конечные точки (12)

• Changes in serum iron levels (μg/dL) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in serum zinc levels (μg/dL) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in ferritin (ng/mL) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in C-reactive protein (CRP) (mg/L) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in fecal calprotectin (µg/g) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in Erythrocyte Sedimentation Rate (ESR) (mm) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Changes in Quality of Life (QoL) using WHOQOL-BREF questionnaire [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)]
• Harvey-Bradshaw Index (HBI) Score [Срок оценки: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]
• Mayo Score for Ulcerative Colitis [Срок оценки: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Греция · 1 центр

• School of Physical Education, Sport Science and Dietetics — Trikala

Идентификаторы

NCT: NCT07380022 · 92/25.6.2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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