Health Impacts of Street Vended Fruits (HISVF)

March 18, 2025 updated by: Md. Ariful Islam, Bangladesh Agricultural University

Health Impacts of Fresh Cut Street Vended Fruits: a Controlled Intervention Study

This study will employ a randomized controlled intervention design to evaluate the health impacts of consuming fresh-cut street-vended fruits, focusing on microbial contamination and gastrointestinal (GI) symptoms. A total of 300 participants will be recruited and divided into treatment (consuming guava, pineapple, or watermelon) and control groups (no fruit consumption). Fruit samples will be analyzed for microbial contamination, including S. aureus and E. coli, using standard microbiological and molecular techniques. Data on GI symptoms will be collected through questionnaires and analyzed using statistical methods, such as Chi-square tests, Kaplan-Meier survival analysis, and Cox proportional hazards regression. Spearman correlation will identify associations between bacterial presence and specific symptoms. Ethical approval will be obtained, and participant safety will be prioritized. Analytical tools, including IBM SPSS, RStudio, and PyCharm, will be utilized for the analyses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

639

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Mymensingh, Bangladesh, 2202
        • Department of Microbiology and Hygiene, Bangladesh Agricultural University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals aged 18-60 years.
  • Residents of Mymensingh District, Bangladesh.
  • Willing to consume fresh-cut street-vended fruits (guava, pineapple, or watermelon) for five consecutive days.
  • Individuals with a self-reported history of gastric acidity issues (for the gastric acidity arms).
  • Individuals with no history of gastric acidity (for the non-gastric acidity arms).
  • Participants who have not taken antibiotics, proton pump inhibitors (PPIs), or antacids in the last two weeks.
  • Willing to provide detailed information on their dietary habits and gastrointestinal symptoms through surveys/questionnaires.
  • Participants who provide informed consent for participation.

Exclusion Criteria:

  • Individuals under 18 years or over 60 years.
  • Pregnant or lactating women.
  • Those with a diagnosed gastrointestinal disorder (e.g., peptic ulcer disease, irritable bowel syndrome, Crohn's disease).
  • Individuals with a history of chronic infections or immune-compromising conditions (e.g., HIV/AIDS, cancer, diabetes).
  • Participants who have taken antibiotics, PPIs, or antacids within the last two weeks.
  • Individuals with known allergies to guava, pineapple, or watermelon.
  • Those who refuse to consume fresh-cut fruits from street vendors.
  • Participants who do not provide informed consent or are unable to complete the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group (No Fresh-Cut Fruit Consumption)
Participants in this group did not consume any street-vended fresh-cut fruits. They continued their usual dietary habits, avoiding any foods that could potentially cause irritation or foodborne illness. This group served as a baseline for comparison against the treatment groups.
Experimental: Fresh-Cut Fruit Consumers with Gastric Acidity (Guava)
Participants with pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Their health status was monitored for five days post-consumption, focusing on gastrointestinal (GI) symptoms and microbial contamination effects.
Dietary supplement: Fresh-Cut Guava Consumption (With Gastric Acidity)
Same as intervention 2, but in participants with acidity
Experimental: Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple)
Participants with pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. Post-consumption symptoms and microbial contamination were assessed over a five-day period.
Dietary supplement: Fresh-Cut Pineapple Consumption (With Gastric Acidity)
Same as intervention 3, but in participants with acidity.
Experimental: Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon)
Participants with pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and potential microbial contamination effects were monitored for five days.
Dietary supplement: Fresh-Cut Watermelon Consumption (With Gastric Acidity)
Same as intervention 4, but in participants with acidity.
Experimental: Fresh-Cut Fruit Consumers without Gastric Acidity (Guava)
Participants without pre-existing gastric acidity conditions consumed fresh-cut guava from street vendors. Health status was tracked for five days, with a focus on microbial contamination and foodborne illness symptoms.
Dietary supplement: Fresh-Cut Guava Consumption
Participants eat a defined portion of guava.
Experimental: Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple)
Participants without pre-existing gastric acidity conditions consumed fresh-cut pineapple from street vendors. The study monitored their health for five days to evaluate any adverse effects.
Dietary supplement: Fresh-Cut Pineapple Consumption
Participants consumed fresh-cut pineapple purchased from street vendors. Health outcomes, including potential microbial contamination and GI symptoms, were assessed for five days after consumption.
Experimental: Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon)
Participants without pre-existing gastric acidity conditions consumed fresh-cut watermelon from street vendors. GI symptoms and microbial contamination effects were assessed over five days.
Dietary supplement: Fresh-Cut Watermelon Consumption
Fresh-Cut Watermelon Consumption Description: Participants consumed fresh-cut watermelon obtained from street vendors. GI symptoms and microbial contamination effects were monitored for five days following consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits
Time Frame: From enrollment to the end of treatment at 10 days
From enrollment to the end of treatment at 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bangladesh Agricultural University

Investigators

  • Principal Investigator: Md. Ariful Islam, PhD, Bangladesh Agricultural University, Mymensingh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2025

Primary Completion (Actual)

March 19, 2025

Study Completion (Actual)

March 19, 2025

Study Registration Dates

First Submitted

February 23, 2025

First Submitted That Met QC Criteria

March 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWEEC/BAU/2024(2)/15(a) (Other Identifier: Animal Welfare and Experimentation Ethics Committee, Bangladesh Agricultural University, Mymensingh 2202)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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