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.

NCT07380022 | Recruiting DMC

• 1 other identifier: 92/25.6.2025
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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, 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

Keywords

ACCEPTABILITY; DIETARY SUPPLEMENT; PHYTASE

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Changes in serum iron levels (μg/dL)

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

• Changes in serum zinc levels (μg/dL)

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

• Changes in ferritin (ng/mL)

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

• Changes in C-reactive protein (CRP) (mg/L)

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

• Changes in fecal calprotectin (µg/g)

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

Study Arms (2)

Dietary supplement intervention Goodphyte IB Defense

OTHER

50 Participants will receive dietary supplement Goodphyte IB Defense

Dietary Supplement: Dietary supplement intervention Goodphyte IB Defense

Dietary supplement intervention Goodphyte Immunity

OTHER

50 Participants will receive dietary supplement Goodphyte Immunity

Dietary Supplement: Dietary supplement intervention Goodphyte Immunity

Interventions

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 IB Defense

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.

Dietary supplement intervention Goodphyte Immunity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

Study Sites (1)

School of Physical Education, Sport Science and Dietetics

Trikala, Thessaly, 42132, Greece

RECRUITING

MeSH Terms

Conditions

Hypertension; Multiple Sclerosis; Anemia; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ODYSSEAS ANDROUTSOS

  School of Physical Education, Sport Science and Dietetics

  STUDY DIRECTOR

Central Study Contacts

VAIOS SVOLOS, PhD

CONTACT

+306989953903; vaiossvolos@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian, Postdoctoral Researcher

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 2, 2026
• Study Start: July 9, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)