Health Impacts of Street Vended Fruits

NCT06858046 | Completed DMC

• 1 other identifier: AWEEC/BAU/2024(2)/15(a)
• Study Type: interventional
• Target: 639
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  From enrollment to the end of treatment at 10 days

Study Arms (7)

Control Group (No Fresh-Cut Fruit Consumption)

NO INTERVENTION

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

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)

Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple)

EXPERIMENTAL

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)

Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon)

EXPERIMENTAL

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)

Fresh-Cut Fruit Consumers without Gastric Acidity (Guava)

EXPERIMENTAL

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

Fresh-Cut Fruit Consumers without Gastric Acidity (Pineapple)

EXPERIMENTAL

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

Fresh-Cut Fruit Consumers without Gastric Acidity (Watermelon)

EXPERIMENTAL

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

Interventions

Fresh-Cut Guava Consumption DIETARY_SUPPLEMENT

Participants eat a defined portion of guava.

Fresh-Cut Fruit Consumers without Gastric Acidity (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 Fruit Consumers without Gastric Acidity (Pineapple)

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 Fruit Consumers without Gastric Acidity (Watermelon)

Fresh-Cut Guava Consumption (With Gastric Acidity) DIETARY_SUPPLEMENT

Same as intervention 2, but in participants with acidity

Fresh-Cut Fruit Consumers with Gastric Acidity (Guava)

Fresh-Cut Pineapple Consumption (With Gastric Acidity) DIETARY_SUPPLEMENT

Same as intervention 3, but in participants with acidity.

Fresh-Cut Fruit Consumers with Gastric Acidity (Pineapple)

Fresh-Cut Watermelon Consumption (With Gastric Acidity) DIETARY_SUPPLEMENT

Same as intervention 4, but in participants with acidity.

Fresh-Cut Fruit Consumers with Gastric Acidity (Watermelon)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Agricultural University: lead

Study Sites (1)

Department of Microbiology and Hygiene, Bangladesh Agricultural University

Mymensingh, 2202, Bangladesh

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Foodborne Diseases; Staphylococcal Infections; Escherichia coli Infections

Condition Hierarchy (Ancestors)

Digestive System Diseases; Poisoning; Chemically-Induced Disorders; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections

Study Officials

• Md. Ariful Islam, PhD

  Bangladesh Agricultural University, Mymensingh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 5, 2025
• Study Start: March 6, 2025
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

BA (1)