Health Impacts of Street Vended Fruits (HISVF)

Bangladesh Agricultural University

Status: Completed

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

Treatments: Dietary Supplement: Fresh-Cut Watermelon Consumption (With Gastric Acidity); Dietary Supplement: Fresh-Cut Watermelon Consumption; Dietary Supplement: Fresh-Cut Guava Consumption; Dietary Supplement: Fresh-Cut Pineapple Consumption; Dietary Supplement: Fresh-Cut Pineapple Consumption (With Gastric Acidity); Dietary Supplement: Fresh-Cut Guava Consumption (With Gastric Acidity)

Study type: Interventional

Funder types: Other

Identifiers

NCT06858046

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

Details and patient eligibility

About

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.

Enrollment: 639 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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639 participants in 7 patient groups

Control Group (No Fresh-Cut Fruit Consumption)

No Intervention group

Description:

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.

Fresh-Cut Fruit Consumers with Gastric Acidity (Guava)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Guava Consumption (With Gastric Acidity)

Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Pineapple Consumption (With Gastric Acidity)

Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Watermelon Consumption (With Gastric Acidity)

Fresh-Cut Fruit Consumers without Gastric Acidity (Guava)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Guava Consumption

Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Pineapple Consumption

Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fresh-Cut Watermelon Consumption