Analysis of MicroBial Metabolites After Eating Refined Food

Not Applicable

Active, not recruiting

• Conditions: Dietary Habits
• Interventions: Other: Ultra-processed Food Meal; Other: Whole Food Meal

• Registration Number: NCT04308473
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-11
• Study First Posted: 2020-03-16
• Study Start: 2020-09-01
• Primary Completion: 2023-02-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-27
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• Men and women age 18 years or above.
• Able to provide informed consent and comply with study protocol
• Able to remain on a stable aspirin regimen (either on or off aspirin or aspirin products) for 1 week prior to starting study until the end of the study period.

Exclusion Criteria

• Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
• Active infection or received antibiotics within 6 months of study enrollment.
• Use of over-the-counter probiotic within past month.
• Chronic gastrointestinal disorders.
• Intolerance to probiotic therapy.
• Allergy to vancomycin, ciprofloxacin, neomycin, metronidazole, or lactose.
• Allergy to any of the food components of the challenge meals.
• Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Ultra-processed Meal + Antibiotics to supress gut flora	Ultra-processed Food Meal	Subjects in Arm 1 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of ultra-processed foods.
Arm 2: Ultra-processed Meal + No Antibiotics	Ultra-processed Food Meal	Subjects in Arm 2 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of ultra-processed foods.
Arm 4: Whole Food Meal + No Antibiotics	Whole Food Meal	Subjects in Arm 4 will not take any antibiotics prior to the meal challenge. They will consume a challenge meal of whole, unprocessed foods.
Arm 3: Whole Food Meal + Antibiotics to supress gut flora	Whole Food Meal	Subjects in Arm 3 will take antibiotics for 3 days before the meal challenge to suppress the gut flora. The antibiotics to be used are: vancomycin, 125 mg three times daily; metronidazole, 500 mg twice daily; ciprofloxacin, 500 mg twice daily; and neomycin, 1 gram three times daily. These subjects will then consume a challenge meal of whole, unprocessed foods.

Primary Outcome Measures

Name	Time	Method
Serial changes in plasma and urine metabolites and biomarkers	Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours	Serial changes in plasma and urine metabolites and biomarkers
Serial changes in plasma and urine TMAO	Pre-meal (baseline) & post-meal at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, and 6 hours	Serial changes in plasma and urine TMAO (trimethylamine N-oxide)

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States