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ACTIVE NOT RECRUITING
NCT04308473
NA

Analysis of MicroBial Metabolites After Eating Refined Food

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2020-09-01

Completion Date

2026-07

Last Updated

2025-07-29

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Cleveland Clinic Main Campus

Cleveland, Ohio, United States