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. (PHYTASE)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Anemia; IBD; Colitis Ulcerative; Hypertension (HTN)
• Intervention / Treatment: Dietary supplement: Dietary supplement intervention Goodphyte IB Defense; Dietary supplement: Dietary supplement intervention Goodphyte Immunity

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: VAIOS SVOLOS, PhD; Phone Number: +306989953903; Email: vaiossvolos@gmail.com

Study Locations

• Greece
  • Thessaly
    • Trikala, Thessaly, Greece, 42132
      • Recruiting
      • School of Physical Education, Sport Science and Dietetics
      • Contact: School of Physical Education, Sport Science and Dietetics; Phone Number: +30 24310 23602; Email: g-dnd@uth.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dietary supplement intervention Goodphyte IB Defense; 50 Participants will receive dietary supplement Goodphyte IB Defense	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.
Other: Dietary supplement intervention Goodphyte Immunity; 50 Participants will receive dietary supplement Goodphyte Immunity	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks (immediately after completion of the 2-week intervention)
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.	From enrollment to the end of treatment at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
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.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
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.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
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.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Changes in fecal calprotectin (µg/g)	In participants with Inflammatory Bowel Disease (IBD), fecal calprotectin will be measured as a non-invasive marker of intestinal inflammation. Stool samples will be collected before and after the intervention. All laboratory analyses will be performed using standardized and validated methods.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Changes in Erythrocyte Sedimentation Rate (ESR) (mm)	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 Erythrocyte Sedimentation Rate (ESR). All laboratory analyses will be performed using standardized and validated methods.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Changes in Quality of Life (QoL) using WHOQOL-BREF questionnaire	Quality of Life (QoL) will be assessed using internationally recognized questionnaire for the evaluation of participants' subjective well-being, such as WHOQOL-BREF: The World Health Organization Quality of Life-Abbreviated version. Domain scores will be calculated and transformed to a 0-100 scale according to World Health Organization guidelines, with higher scores indicating better quality of life.	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	Quality of Life (QoL) will be assessed using internationally recognized questionnaire for the evaluation of participants' subjective well-being, such as EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L index score will be calculated using the validated country-specific value set, converting health states into a single index value ranging from 0 to 1, where higher values indicate better health-related quality of life.	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	Participants will complete the Chalder Fatigue Scale (CFQ) questionnaire, which consists of 11 Likert-scale questions designed to distinguish between physical and mental fatigue. Responses will be scored using the Likert method (0-3), yielding a total fatigue score ranging from 0 to 33, with higher scores indicating greater fatigue severity.	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)	Body Mass Index (BMI) will be assessed as a measure of body composition. BMI will be calculated using measured body weight and height (kg/m²) at baseline, during the intervention, and at the end of the intervention to evaluate changes over time.	Baseline (Day 0) and 2 weeks (immediately after completion of the 2-week intervention)
Harvey-Bradshaw Index (HBI) Score	Self-reported disease activity in patients with Crohn's disease will be assessed using the Harvey-Bradshaw Index (HBI), summing points from general well-being, abdominal pain, liquid stools, abdominal mass, and complications. Scores typically indicate: <5 (remission), 5-7 (mild), 8-16 (moderate), and >16 (severe) activity.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Mayo Score for Ulcerative Colitis	Self-reported disease activity in patients with ulcerative colitis will be assessed using the Mayo Score, a 0-12 point system assessing disease severity by combining patient symptoms (stool frequency, rectal bleeding) with endoscopic findings (mucosal appearance) and a physician's global assessment, with higher scores indicating more severe inflammation.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Inflammatory Bowel Disease Disk (IBD-Disk) Score	Patient-reported symptom severity and disease-related burden in ulcerative colitis and Crohn's disease will be assessed using the Inflammatory Bowel Disease Disk (IBD-Disk) tool. It is a 10-item, visual, self-administered tool. Patients rate 10 key areas (like abdominal pain, energy, sleep, emotions) on a 0-10 scale, resulting in a total score from 0 to 100, where higher scores indicate greater disability.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Multiple Sclerosis Impact Scale (MSIS-29) Score	Self-reported physical and psychological impact of multiple sclerosis will be assessed using the Multiple Sclerosis Impact Scale (MSIS-29). The scores will be summed and converted to a 0-100 scale for each domain, with 100 being the worst.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Modified Fatigue Impact Scale (MFIS) Score	Fatigue severity and its impact on daily functioning in patients with multiple sclerosis will be assessed using the Modified Fatigue Impact Scale (MFIS). It reflects how fatigue affects daily life, with a total range of 0-84, where higher scores mean greater impact, broken into physical (0-36), cognitive (0-40), and psychosocial (0-8) subscales.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Hypertension-Related Symptom Score	Self-reported hypertension-related symptoms, including dizziness and headache, assessed using a weekly symptom questionnaire. Symptom severity will be evaluated at baseline, during the intervention, and at the end of the intervention.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Anemia-Related Symptom Score	Self-reported anemia-related symptoms, including fatigue, shortness of breath, and weakness, assessed using a weekly symptom questionnaire. Assessments will be conducted at baseline, during the intervention, and at the end of the intervention.	Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)

Collaborators and Investigators

• Sponsor: University of Thessaly
• Investigators: Study Director: ODYSSEAS ANDROUTSOS, School of Physical Education, Sport Science and Dietetics

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ACCEPTABILITY; DIETARY SUPPLEMENT; PHYTASE
• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intestinal Diseases; Autoimmune Diseases; Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hematologic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Hemic and Lymphatic Diseases; Hypertension; Multiple Sclerosis; Colitis, Ulcerative; Anemia
• Other Study ID Numbers: 92/25.6.2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No