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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Thessaly

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Dietary supplement intervention Goodphyte IB Defense

    Dietary supplement

    Participants 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 supplement

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Dietary supplement intervention Goodphyte IB DefenseOther 1 intervention
Group B: Dietary supplement intervention Goodphyte ImmunityOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
From enrollment to the end of treatment at 2 weeks

Secondary outcomes

1

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.

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

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.

Time frame
Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
3

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.

Time frame
Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
4

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.

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

Other outcomes

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