Ulcer Pomegranate Muffins

University of Lahore

Status: Completed

Conditions: Peptic Ulcer; Gastric

Treatments: Dietary Supplement: WHOLE WHEAT MUFFIN; Combination Product: 1.5g enriched pomegranate muffins; Combination Product: 3g enriched pomegranate muffins

Study type: Interventional

Funder types: Other

Identifiers

NCT07123259

REC-UOL-/530/08/24

Details and patient eligibility

About

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.

Full 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).

Enrollment: 82 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

82 participants in 3 patient groups, including a placebo group

Treatment 1 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5g)

Active Comparator group

Treatment:

Combination Product: 1.5g enriched pomegranate muffins

Treatment 2 group: Whole wheat muffin enriched with pomegranate peel powder (PPP=3g)

Active Comparator group

Treatment:

Combination Product: 3g enriched pomegranate muffins

Group T0: Whole wheat muffin

Placebo Comparator group

Description:

400g whole wheat flour was used to formulate the muffins

Treatment:

Dietary Supplement: WHOLE WHEAT MUFFIN