NCT07789561

Brief Summary

Background/Objective: This study evaluated the effects of pomegranate peel powder (PPP)-enriched muffins containing 1.5 g or 2.5 g PPP on H. pylori, inflammation, oxidative stress, and gastric ulcer healing in patients with gastric ulcers. Conclusion: PPP-enriched muffins showed potential as a functional dietary intervention for improving antioxidant and anti-inflammatory status and supporting gastric ulcer healing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2026

Completed
Last Updated

August 27, 2026

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

August 24, 2026

Last Update Submit

August 24, 2026

Conditions

UlcerBlood TestsLiver Function Tests

Keywords

Punica granatum,Gastric UlcerHelicobacter pyloriFunctional Foods

Outcome Measures

Primary Outcomes (1)

  • Liver Enzymes

    9 weeks

Secondary Outcomes (1)

  • H.phylori

    9 weeks

Study Arms (3)

T0: placebo

PLACEBO COMPARATOR

wheat muffin

Dietary Supplement: Whole wheat muffin

T1= muffin with 1.5g ppp

EXPERIMENTAL

Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5g) + conventional Therapy

Dietary Supplement: pomegranate peel powder 1.5 g

T2= Muffin with 3g ppp

EXPERIMENTAL

Whole wheat muffin enriched with pomegranate peel powder (PPP=2.5g) + conventional Therapy

Dietary Supplement: pomegranate peel powder 3 g

Interventions

pomegranate peel powder 1.5 gDIETARY_SUPPLEMENT

Whole wheat muffin enriched with pomegranate peel powder (PPP=1.5 g) + conventional Therapy

T1= muffin with 1.5g ppp
pomegranate peel powder 3 gDIETARY_SUPPLEMENT

Whole wheat muffin enriched with pomegranate peel powder (PPP=3g) + conventional Therapy

T2= Muffin with 3g ppp
Whole wheat muffinDIETARY_SUPPLEMENT

Whole wheat muffin

T0: placebo

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female patients aged 40-60 years with confirmed Helicobacter pylori infection, verified through stool antigen testing along with elevated pepsinogen I and II levels, were included in the study

You may not qualify if:

  • pregnancy or lactation, history of gastric surgery, and current use of proton pump inhibitors. and use of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sana Noreen

Lahore, Punjab Province, 54000, Pakistan

Location

Related Links

MeSH Terms

Conditions

UlcerStomach Ulcer

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPeptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

August 27, 2026

Study Start

February 15, 2024

Primary Completion

May 5, 2024

Study Completion

May 7, 2024

Last Updated

August 27, 2026

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)