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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
639

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangladesh Agricultural University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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