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Completed

NCT Number: NCT06858046

Health Impacts of Street Vended Fruits

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.

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Key information

Conditions

Gastrointestinal Diseases Bacterial Infections Bacterial Infections and Mycoses Chemically-Induced Disorders Digestive System Diseases Enterobacteriaceae Infections Escherichia Coli Escherichia coli Infections Foodborne Diseases Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infections Microbial Contamination Poisoning S. Aureus Staphylococcal Infections Street Vended Foods Total Viable Count

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Microbiology and Hygiene, Bangladesh Agricultural University

Mymensingh, 2202, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fresh-Cut Guava Consumption

Dietary Supplement

Participants eat a defined portion of guava.

Fresh-Cut Pineapple Consumption

Dietary Supplement

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.

Fresh-Cut Watermelon Consumption

Dietary Supplement

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.

Fresh-Cut Guava Consumption (With Gastric Acidity)

Dietary Supplement

Same as intervention 2, but in participants with acidity

Fresh-Cut Pineapple Consumption (With Gastric Acidity)

Dietary Supplement

Same as intervention 3, but in participants with acidity.

Fresh-Cut Watermelon Consumption (With Gastric Acidity)

Dietary Supplement

Same as intervention 4, but in participants with acidity.

Primary outcomes

  1. Prevalence of Gastrointestinal Symptoms Among Participants After Consumption of Fresh-Cut Fruits

    Time frame: From enrollment to the end of treatment at 10 days

Sponsors and collaborators

Lead sponsor

Bangladesh Agricultural University

Other

Registry information

Official study title

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

Acronym: HISVF

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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