Health Impacts of Street Vended Fruits

NCT ID: NCT06858046

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 639 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-06
• Study Completion Date: 2025-03-19

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Fresh-Cut Guava Consumption (With Gastric Acidity)

Intervention Type: DIETARY_SUPPLEMENT

Same as intervention 2, but in participants with acidity

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.

Group Type: EXPERIMENTAL

Fresh-Cut Pineapple Consumption (With Gastric Acidity)

Intervention Type: DIETARY_SUPPLEMENT

Same as intervention 3, but in participants with acidity.

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.

Group Type: EXPERIMENTAL

Fresh-Cut Watermelon Consumption (With Gastric Acidity)

Intervention Type: DIETARY_SUPPLEMENT

Same as intervention 4, but in participants with acidity.

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.

Group Type: EXPERIMENTAL

Fresh-Cut Guava Consumption

Intervention Type: DIETARY_SUPPLEMENT

Participants eat a defined portion of guava.

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.

Group Type: EXPERIMENTAL

Fresh-Cut Pineapple Consumption

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Fresh-Cut Watermelon Consumption

Intervention Type: 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.

Interventions

Fresh-Cut Guava Consumption

Participants eat a defined portion of guava.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Fresh-Cut Guava Consumption (With Gastric Acidity)

Same as intervention 2, but in participants with acidity

Intervention Type: DIETARY_SUPPLEMENT

Fresh-Cut Pineapple Consumption (With Gastric Acidity)

Same as intervention 3, but in participants with acidity.

Intervention Type: DIETARY_SUPPLEMENT

Fresh-Cut Watermelon Consumption (With Gastric Acidity)

Same as intervention 4, but in participants with acidity.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bangladesh Agricultural University

OTHER

Sponsor Role: lead

Responsible Party

Md. Ariful Islam

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Md. Ariful Islam, PhD

Role: PRINCIPAL_INVESTIGATOR

Bangladesh Agricultural University, Mymensingh

Locations

Department of Microbiology and Hygiene, Bangladesh Agricultural University

Mymensingh, , Bangladesh

Countries

Bangladesh

Other Identifiers

AWEEC/BAU/2024(2)/15(a)

Identifier Type: OTHER

Identifier Source: secondary_id

AWEEC/BAU/2024(2)/15(a)

Identifier Type: -

Identifier Source: org_study_id