About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Dietary supplement intervention Goodphyte IB Defense
Dietary supplementParticipants will receive orally Goodphyte IB Defense at a dose of four capsules per day for a duration of two weeks.
Dietary supplement intervention Goodphyte Immunity
Dietary supplementParticipants will receive orally Goodphyte IB Immunity at a dose of four capsules per day for a duration of two weeks.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity using an acceptability questionnaire
Acceptability will be measured using an acceptability questionnaire completed at the end of the intervention. The questionnaire will include items assessing ease of intake, difficulties in integrating the supplement into daily routines, perceived safety, overall study experience, and intention to continue product use. Responses will be recorded using a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree), allowing quantitative analysis.
Adherence to the Intervention
Adherence will be assessed by recording the number of days participants consumed the supplement and the quantity consumed during the intervention period. Daily adherence will be documented using a self-reported compliance form. Participant completion and withdrawal rates will be recorded, and reasons for withdrawal will be analyzed when available.
Secondary outcomes
Changes in serum iron levels (μg/dL)
The effect of supplementation with Goodphyte IB Defense and Goodphyte Immunity on iron status will be evaluated. Blood samples will be collected before and after the intervention to measure serum iron. All laboratory analyses will be performed using standardized and validated methods.
Changes in serum zinc levels (μg/dL)
The effect of supplementation with Goodphyte IB Defense and Goodphyte Immunity on zinc status will be evaluated. Blood samples will be collected before and after the intervention to measure serum zinc. All laboratory analyses will be performed using standardized and validated methods.
Changes in ferritin (ng/mL)
The effect of supplementation with Goodphyte IB Defense and Goodphyte Immunity on inflammatory markers will be evaluated. Blood samples will be collected before and after the intervention to measure ferritin. All laboratory analyses will be performed using standardized and validated methods.
Changes in C-reactive protein (CRP) (mg/L)
The effect of supplementation with Goodphyte IB Defense and Goodphyte Immunity on inflammatory markers will be evaluated. Blood samples will be collected before and after the intervention to measure C-reactive protein (CRP). All laboratory analyses will be performed using standardized and validated methods.
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