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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Are there results?
None posted in the registry

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

Other trials in Greece

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.

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 groups in NCT07380022
Study groupRoleWhat they receive
Dietary supplement intervention Goodphyte IB DefenseOther50 Participants will receive dietary supplement Goodphyte IB Defense
Receives: Dietary Supplement: Dietary supplement intervention Goodphyte IB Defense
Dietary supplement intervention Goodphyte ImmunityOther50 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.

  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.

    Measured: 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.

    Measured: From enrollment to the end of treatment at 2 weeks

Secondary outcomes (17)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. 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)

  14. 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)

  15. 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)

  16. 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)

  17. 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.

  1. First posted2 Feb 2026
  2. Study start9 Jul 2025
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity using an acceptability questionnaire (time frame: 2 weeks (immediately after completion of the 2-week intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.

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