GastricNCT07123259
Ulcer Pomegranate Muffins
A study testing WHOLE WHEAT MUFFIN, 1.5g enriched pomegranate muffins and 3g enriched pomegranate muffins in people with Gastric and Peptic Ulcer, run by University of Lahore at 1 site in Pakistan.
Trial summary
Pomegranate (Punica granatum L.) peel powder, known for its potent antioxidant, anti-inflammatory, and antimicrobial properties, has shown promise in the dietary management of gastrointestinal disorders. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric, Peptic Ulcer
- What is being tested?
- WHOLE WHEAT MUFFIN, 1.5g enriched pomegranate muffins and 3g enriched pomegranate muffins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2024to 12 Oct 2024
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female patients aged 45-60 years with confirmed Helicobacter pylori
- infection verified through a stool antigen test (pH 7.0-7.5)
- elevated levels of pepsinogen I and II
Who cannot join
- pregnancy or lactation
- history of gastric surgery
- current use of proton pump inhibitors (PPIs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Ulcerative Colitis Activity of Pomegranate (Punica Granatum L.) Peel Powder Muffins in Patients With Gastric Ulcer
Pomegranate (Punica granatum L.) peel powder, known for its potent antioxidant, anti-inflammatory, and antimicrobial properties, has shown promise in the dietary management of gastrointestinal disorders. In recent clinical observations, incorporating pomegranate peel powder into muffins consumed by patients with gastric ulcers demonstrated potential anti-ulcerative colitis activity. The bioactive compounds in the peel, such as polyphenols (punicalagins, ellagic acid), help reduce oxidative stress and modulate inflammatory pathways in the gut. Patients consuming these enriched muffins reported improvements in gastrointestinal symptoms, reduced mucosal inflammation, and enhanced mucosal healing, suggesting a supportive role of pomegranate peel as a functional food ingredient in managing gastric and colitis-related conditions.
Read the detailed description
- Materials and Methods 2.1. Ethical Statement The study received ethical approval from the Research Ethics Committee (REC) of the University of Lahore (REC-UOL-/530/08/24). Informed consent was obtained from all participants, who were fully informed about the study's aims, methods, risks, and benefits, and were given the opportunity to ask questions and withdraw at any time.
2.2. Settings The research was undertaken at Umair Clinic, Gondal Chowk, Kacha Jail Road, Lahore, whereas laboratory work and muffin preparation were done at the Food Science and Nutrition Laboratory (FASH Lab 502), UIDNS, The University of Lahore, Lahore, Pakistan.
2.3. Subjects A randomized controlled trial (RCT) was conducted using a purposive sampling strategy. Initially, 88 patients were enrolled, accounting for a projected 20% dropout rate. One patient was excluded for not meeting the inclusion criteria, resulting in 87 eligible participants. These were randomly and equally assigned into three groups, with 29 patients in each group. During the study, two patients were excluded from the placebo Group (T0), leaving 27 participants. In Group 2 (T1), two patients were excluded, and one participant voluntarily withdrew due to personal health issues from Group 3 (T2). Ultimately, a total of 82 patients completed the 8-week trial study.
2.4. Intervention groups Group T1 received one muffin per day enriched with 1.5 g of pomegranate peel powder (PPP), alongside conventional medical therapy. Group T2 received two PPP-enriched muffins per day (totaling 3 g of PPP), in addition to conventional therapy. The placebo group received one whole wheat muffin per day without PPP supplementation. All participants consumed their assigned muffins once daily for 8 weeks 2.4.1 Demographic Profile Demographic data among ulcer patients, including age, gender, and socioeconomic status, were collected at baseline using a structured questionnaire (Saber et al., 2021).
- Conditions
- Gastric, Peptic Ulcer
- Being tested
- WHOLE WHEAT MUFFIN, 1.5g enriched pomegranate muffins, 3g enriched pomegranate muffins
- Keywords
- Punica granatum, Gastric Ulcer, Ulcerative Colitis, Helicobacter pylori
- Medical subject headings
- Peptic Ulcer, Stomach Ulcer, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHOLE WHEAT MUFFINDietary supplement
400g whole wheat flour was used for the development of muffins
1.5g enriched pomegranate muffinsCombination product
1.5 g of pomegranate peel powder (PPP), alongside conventional medical therapy
3g enriched pomegranate muffinsCombination product
3 g of pomegranate peel powder (PPP), alongside conventional medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5g) | Active comparator | Not described Receives: Combination Product: 1.5g enriched pomegranate muffins |
| Treatment 2 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=3g) | Active comparator | Not described Receives: Combination Product: 3g enriched pomegranate muffins |
| Group T0: Whole wheat muffin | Placebo comparator | 400g whole wheat flour was used to formulate the muffins Receives: Dietary Supplement: WHOLE WHEAT MUFFIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pepsinogen I and II Levels
Pepsinogen I and II levels were measured using an enzyme-linked immunosorbent assay (ELISA). These biomarkers were assessed to evaluate gastric mucosal integrity, with elevated levels indicating gastric inflammation and aiding in the diagnosis and monitoring of ulcer severity and progression (Zhang et al., 2024).
Measured: 8 WEEKS
Helicobacter pylori Test
Pepsinogen I and II levels were measured using an enzyme-linked immunosorbent assay (ELISA). These biomarkers were assessed to evaluate gastric mucosal integrity, with elevated levels indicating gastric inflammation and aiding in the diagnosis and monitoring of ulcer severity and progression (Zhang et al., 2024).
Measured: 8 WEEKS
Secondary outcomes (3)
Complete blood count
A complete blood count (CBC) was conducted using an automated hematology analyzer on EDTA-anticoagulated blood samples. Key parameters such as hemoglobin, RBC, WBC and platelet count were evaluated (Saleska et al., 2024).
Measured: 8 Weeks
Liver function assay
Serum AST, ALT, and ALP were measured using an enzymatic colorimetric technique (Jalili et al., 2022).
Measured: 8 Weeks
Barium Test
A barium swallow test was performed using oral barium sulfate and X-ray imaging to detect ulcers and structural abnormalities in the upper gastrointestinal tract (Kusano et al., 2024)
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start10 Aug 2024
- Primary completion10 Oct 2024
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GastricStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Noreen, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07123259
- Sponsor's protocol ID
- REC-UOL-/530/08/24
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the Individual Participant Data (IPD) collected during the study with other qualified researchers upon reasonable request. The shared data will include de-identified participant-level data related to baseline characteristics, intervention, outcomes, and adverse events.
Publications
Kamali M, Tavakoli H, Khodadoost M, Daghaghzadeh H, Kamalinejad M, Gachkar L, Mansourian M, Adibi P. Efficacy of the Punica granatum peels aqueous extract for symptom management in ulcerative colitis patients. A randomized, placebo-controlled, clinical trial. Complement Ther Clin Pract. 2015 Aug;21(3):141-6. doi: 10.1016/j.ctcp.2015.03.001. Epub 2015 Apr 1.
PubMed 26256131
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Ulcerative Colitis Activity of Pomegranate (Punica Granatum L.) Peel Powder Muffins in Patients With Gastric Ulcer
- ClinicalTrials.gov ID
- NCT07123259
- Acronym / sponsor ID
- REC-UOL-/530/08/24
- Conditions
- Gastric, Peptic Ulcer
- Keywords
- Punica granatum, Gastric Ulcer, Ulcerative Colitis, Helicobacter pylori
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pomegranate (Punica granatum L.) peel powder, known for its potent antioxidant, anti-inflammatory, and antimicrobial properties, has shown promise in the dietary management of gastrointestinal disorders. In recent clinical observations, incorporating pomegranate peel powder into muffins consumed by patients with gastric ulcers demonstrated potential anti-ulcerative colitis activity. The bioactive compounds in the peel, such as polyphenols (punicalagins, ellagic acid), help reduce oxidative stress and modulate inflammatory pathways in the gut. Patients consuming these enriched muffins reported improvements in gastrointestinal symptoms, reduced mucosal inflammation, and enhanced mucosal healing, suggesting a supportive role of pomegranate peel as a functional food ingredient in managing gastric and colitis-related conditions.
Detailed description
- Materials and Methods 2.1. Ethical Statement The study received ethical approval from the Research Ethics Committee (REC) of the University of Lahore (REC-UOL-/530/08/24). Informed consent was obtained from all participants, who were fully informed about the study's aims, methods, risks, and benefits, and were given the opportunity to ask questions and withdraw at any time.
2.2. Settings The research was undertaken at Umair Clinic, Gondal Chowk, Kacha Jail Road, Lahore, whereas laboratory work and muffin preparation were done at the Food Science and Nutrition Laboratory (FASH Lab 502), UIDNS, The University of Lahore, Lahore, Pakistan.
2.3. Subjects A randomized controlled trial (RCT) was conducted using a purposive sampling strategy. Initially, 88 patients were enrolled, accounting for a projected 20% dropout rate. One patient was excluded for not meeting the inclusion criteria, resulting in 87 eligible participants. These were randomly and equally assigned into three groups, with 29 patients in each group. During the study, two patients were excluded from the placebo Group (T0), leaving 27 participants. In Group 2 (T1), two patients were excluded, and one participant voluntarily withdrew due to personal health issues from Group 3 (T2). Ultimately, a total of 82 patients completed the 8-week trial study.
2.4. Intervention groups Group T1 received one muffin per day enriched with 1.5 g of pomegranate peel powder (PPP), alongside conventional medical therapy. Group T2 received two PPP-enriched muffins per day (totaling 3 g of PPP), in addition to conventional therapy. The placebo group received one whole wheat muffin per day without PPP supplementation. All participants consumed their assigned muffins once daily for 8 weeks 2.4.1 Demographic Profile Demographic data among ulcer patients, including age, gender, and socioeconomic status, were collected at baseline using a structured questionnaire (Saber et al., 2021).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5g) | Active comparator | Combination Product: 1.5g enriched pomegranate muffins |
| Treatment 2 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=3g) | Active comparator | Combination Product: 3g enriched pomegranate muffins |
| Group T0: Whole wheat muffin | Placebo comparator | Dietary Supplement: WHOLE WHEAT MUFFIN400g whole wheat flour was used to formulate the muffins |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both male and female patients aged 45-60 years with confirmed Helicobacter pylori
- infection verified through a stool antigen test (pH 7.0-7.5)
- elevated levels of pepsinogen I and II
Key exclusion criteria (3 listed)
- pregnancy or lactation
- history of gastric surgery
- current use of proton pump inhibitors (PPIs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WHOLE WHEAT MUFFIN400g whole wheat flour was used for the development of muffins | Dietary supplement | Group T0: Whole wheat muffin |
| 1.5g enriched pomegranate muffins1.5 g of pomegranate peel powder (PPP), alongside conventional medical therapy | Combination product | Treatment 1 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5g) |
| 3g enriched pomegranate muffins3 g of pomegranate peel powder (PPP), alongside conventional medical therapy | Combination product | Treatment 2 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=3g) |
Primary outcome
Pepsinogen I and II Levels
Time frame: 8 WEEKS
Pepsinogen I and II levels were measured using an enzyme-linked immunosorbent assay (ELISA). These biomarkers were assessed to evaluate gastric mucosal integrity, with elevated levels indicating gastric inflammation and aiding in the diagnosis and monitoring of ulcer severity and progression (Zhang et al., 2024).
Helicobacter pylori Test
Time frame: 8 WEEKS
Pepsinogen I and II levels were measured using an enzyme-linked immunosorbent assay (ELISA). These biomarkers were assessed to evaluate gastric mucosal integrity, with elevated levels indicating gastric inflammation and aiding in the diagnosis and monitoring of ulcer severity and progression (Zhang et al., 2024).
3 secondary outcomes
Complete blood count
Time frame: 8 Weeks
Liver function assay
Time frame: 8 Weeks
Barium Test
Time frame: 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 26256131Kamali M, Tavakoli H, Khodadoost M, Daghaghzadeh H, Kamalinejad M, Gachkar L, Mansourian M, Adibi P. Efficacy of the Punica granatum peels aqueous extract for symptom management in ulcerative colitis patients. A randomized, placebo-controlled, clinical trial. Complement Ther Clin Pract. 2015 Aug;21(3):141-6. doi: 10.1016/j.ctcp.2015.03.001. Epub 2015 Apr 1.
- Individual participant dataSharing planned: Yes. We plan to share the Individual Participant Data (IPD) collected during the study with other qualified researchers upon reasonable request. The shared data will include de-identified participant-level data related to baseline characteristics, intervention, outcomes, and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WHOLE WHEAT MUFFIN, 1.5g enriched pomegranate muffins and 3g enriched pomegranate muffins in people with Gastric and Peptic Ulcer, run by University of Lahore at 1 site in Pakistan.
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 3 inclusion and 3 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 19 Aug 2025. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
Pepsinogen I and II Levels (time frame: 8 WEEKS). 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?
On the ClinicalTrials.gov record for NCT07123259, which also lists 1 linked publication.
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 19 Aug 2025.