NCT04308473

Analysis of MicroBial Metabolites After Eating Refined Food

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens after consuming a meal that contains lots of whole foods, like fresh vegetables, instead.

Detailed description

The purpose of this study is to discover more about how the human body and the bacteria living in our intestines, known as "gut flora," react to different foods a person may consume. The investigators want to know if there are differences in compounds measured in a participant's blood and urine after eating different foods. Specifically, the investigators are interested in seeing if there are differences in these compounds after eating ultra-processed foods, like hamburgers and french fries, versus eating whole foods, like fresh fruits and vegetables. The investigators also want to know if the bacteria in our intestines may change the levels of these compounds. To this end, some subjects will be asked to take antibiotics to suppress the gut flora for three days before eating the challenge meal. Suppression of gut flora is a known effect of the antibiotics used in this study. Participants will have two study visits.

Conditions

• Dietary Habits

Interventions

Type	Name	Description
OTHER	Ultra-processed Food Meal	An ultra-processed diet challenge test utilizing 1) potatoes fried in highly refined and processed vegetable oil, including corn, soybean, or canola oil, with wheat and milk derivatives; 2) a beef patty sandwich containing processed American cheese, enriched refined flour, mold inhibitor, preservatives and oxidation/reduction additives such as ascorbic acid, potassium/calcium iodate, alpha-amylase, and azodicarbonamide; and 3) a beverage composed of carbonated water, high fructose corn syrup and caramel coloring. The ultra-processed challenge meal will be obtained from a local restaurant on the day of the challenge test.
OTHER	Whole Food Meal	A whole food diet challenge test utilizing 1) a side salad comprised of fresh leafy vegetables, and typical whole food toppings including fresh onion, fresh tomato, fresh carrots, and raw walnuts with a pure unrefined olive oil salad dressing; 2) a legume-based main dish including chickpeas, lentils and whole grain quinoa; 3) a fresh berry-rich smoothie beverage consisting of organic blueberries, raspberries, strawberries, bananas, and fresh orange juice. The whole food challenge meal will be made by the study team from readily available commercial foods bought from local grocery stores.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-02-28
• Completion: 2026-07-01
• First posted: 2020-03-16
• Last updated: 2025-07-29

Locations

1 site across 1 country: United States