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Analysis of MicroBial Metabolites After Eating Refined Food

NCT04308473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Dietary Habits

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.

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • W. H. Wilson Tang, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2023-02-28
Completion
2026-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308473 on ClinicalTrials.gov