Skip to content

Ulcer Pomegranate Muffins

Anti-Ulcerative Colitis Activity of Pomegranate (Punica Granatum L.) Peel Powder Muffins in Patients With Gastric Ulcer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07123259
Enrollment
82
Registered
2025-08-14
Start date
2024-08-10
Completion date
2024-10-12
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric, Peptic Ulcer

Keywords

Punica granatum, Gastric Ulcer, Ulcerative Colitis, Helicobacter pylori

Brief 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. 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

2\. 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).

Interventions

DIETARY_SUPPLEMENTWHOLE WHEAT MUFFIN

400g whole wheat flour was used for the development of muffins

COMBINATION_PRODUCT1.5g enriched pomegranate muffins

1.5 g of pomegranate peel powder (PPP), alongside conventional medical therapy

COMBINATION_PRODUCT3g enriched pomegranate muffins

3 g of pomegranate peel powder (PPP), alongside conventional medical therapy

Sponsors

University of Lahore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* pregnancy or lactation * history of gastric surgery * current use of proton pump inhibitors (PPIs)

Design outcomes

Primary

MeasureTime frameDescription
Pepsinogen I and II Levels8 WEEKSPepsinogen 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 Test8 WEEKSPepsinogen 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).

Secondary

MeasureTime frameDescription
Complete blood count8 WeeksA 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).
Liver function assay8 WeeksSerum AST, ALT, and ALP were measured using an enzymatic colorimetric technique (Jalili et al., 2022).
Barium Test8 WeeksA 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)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026