Ulcer Pomegranate Muffins

NCT07123259 | Completed DMC

• 1 other identifier: REC-UOL-/530/08/24
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric; Peptic Ulcer

Keywords

Punica granatum; Gastric Ulcer; Ulcerative Colitis; Helicobacter pylori

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  8 WEEKS

Secondary Outcomes (3)

• Complete blood count

  8 Weeks

• Liver function assay

  8 Weeks

• Barium Test

  8 Weeks

Study Arms (3)

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

400g whole wheat flour was used to formulate the muffins

Dietary Supplement: WHOLE WHEAT MUFFIN

Interventions

WHOLE WHEAT MUFFIN DIETARY_SUPPLEMENT

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

Group T0: Whole wheat muffin

1.5g enriched pomegranate muffins COMBINATION_PRODUCT

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

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

3g enriched pomegranate muffins COMBINATION_PRODUCT

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

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

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Sana Noreen

Lahore, 54000, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 26256131 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer; Stomach Ulcer; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Colitis; Gastroenteritis; Inflammatory Bowel Diseases; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: August 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 12, 2024
• Last Updated: August 19, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

PA (1)