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Health Impacts of Street Vended Fruits

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858046
Acronym
HISVF
Enrollment
639
Registered
2025-03-05
Start date
2025-03-06
Completion date
2025-03-19
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Escherichia Coli, Foodborne Diseases, Gastrointestinal Diseases, Microbial Contamination, S. Aureus, Street Vended Foods, Total Viable Count

Keywords

Gastrointestinal Symptoms, Food borne illness, Food safety, Food borne infection, Food poisoning, S. aureus, E. coli, Bacterial contamination, Bacterial load

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTFresh-Cut Guava Consumption

Participants eat a defined portion of guava.

DIETARY_SUPPLEMENTFresh-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.

DIETARY_SUPPLEMENTFresh-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.

DIETARY_SUPPLEMENTFresh-Cut Guava Consumption (With Gastric Acidity)

Same as intervention 2, but in participants with acidity

DIETARY_SUPPLEMENTFresh-Cut Pineapple Consumption (With Gastric Acidity)

Same as intervention 3, but in participants with acidity.

DIETARY_SUPPLEMENTFresh-Cut Watermelon Consumption (With Gastric Acidity)

Same as intervention 4, but in participants with acidity.

Sponsors

Bangladesh Agricultural University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

This study employs a randomized controlled intervention design with a parallel assignment model 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 assigned to one of seven arms: two treatment arms with 75 participants each (one with gastric acidity problems and one without), subdivided into three subgroups based on the type of fruit consumed (guava, pineapple, and watermelon). Additionally, a control group of 75 participants will not consume any fresh-cut street-vended fruits and will follow their usual dietary habits. The primary aim is to assess the microbial load (Total Viable Count, S. aureus, and E. coli) on fruits and its association with the development of GI symptoms. The study will employ statistical analysis techniques, including chi-square tests, relative risk analysis, and correlation studies, to evaluate the impact of fruit consumption on

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut FruitsFrom enrollment to the end of treatment at 10 days

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026