IBDPHYTASENCT07380022
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.
A study testing Dietary supplement intervention Goodphyte IB Defense and Dietary supplement intervention Goodphyte Immunity in people with IBD and Hypertension (HTN), run by University of Thessaly at 1 site in Greece.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Hypertension (HTN), Multiple Sclerosis
- What is being tested?
- Dietary supplement intervention Goodphyte IB Defense and Dietary supplement intervention Goodphyte Immunity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 9 Jul 2025to 28 Feb 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Renal or hepatic disease
- Inability to provide informed consent (including individuals <18 years of age)
- Insufficient understanding of the Greek language
Trial locations and contacts
1 site in 1 country.
Greece1 site
School of Physical Education, Sport Science and Dietetics
Trikala, Thessaly, 42132
About this study
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.
- Conditions
- IBD, Hypertension (HTN), Multiple Sclerosis, Anemia, Colitis Ulcerative
- Being tested
- Dietary supplement intervention Goodphyte IB Defense, Dietary supplement intervention Goodphyte Immunity
- Keywords
- ACCEPTABILITY, DIETARY SUPPLEMENT, PHYTASE
- Medical subject headings
- Hypertension, Multiple Sclerosis, Anemia, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplement intervention Goodphyte IB DefenseDietary 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 ImmunityDietary supplement
Participants will receive orally Goodphyte IB Immunity at a dose of four capsules per day for a duration of two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dietary supplement intervention Goodphyte IB Defense | Other | 50 Participants will receive dietary supplement Goodphyte IB Defense Receives: Dietary Supplement: Dietary supplement intervention Goodphyte IB Defense |
| Dietary supplement intervention Goodphyte Immunity | Other | 50 Participants will receive dietary supplement Goodphyte Immunity Receives: Dietary Supplement: Dietary supplement intervention Goodphyte Immunity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 (baseline), Day 7 (mid-intervention) and Day 14 (immediately after completion of the 2-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start9 Jul 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vaios Svolos, University of Thessaly
- Investigators
- ODYSSEAS ANDROUTSOS, Study director, School of Physical Education, Sport Science and Dietetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380022
- Sponsor's protocol ID
- 92/25.6.2025
- Acronym
- PHYTASE
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No