Ulcer Pomegranate Muffins
- Conditions
- Anti-UlcerativeGastric
- Registration Number
- NCT07123259
- Lead Sponsor
- University of Lahore
- 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. 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)
2.4. 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.
2.5. 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 2.5.1 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).
2.5.2 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).
2.5.3 Helicobacter pylori Test The presence of Helicobacter pylori infection was confirmed using a stool antigen test (Al Ofairi et al., 2024). This non-invasive diagnostic method detects H. pylori antigens in fecal samples and is considered reliable for both initial diagnosis and post-treatment evaluation 2.5.4 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).
2.5.5 Liver function assay Serum AST, ALT, and ALP were measured using an enzymatic colorimetric technique (Jalili et al., 2022).
2.5.6 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
- 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
- pregnancy or lactation
- history of gastric surgery
- current use of proton pump inhibitors (PPIs)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 2.12.5. Pepsinogen I and II Levels 8 WEEKS Helicobacter pylori Test 8 WEEKS The presence of Helicobacter pylori infection was confirmed using a stool antigen test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sana Noreen
🇵🇰Lahore, Pakistan
Sana Noreen🇵🇰Lahore, Pakistan