Effect of Meat and Egg on TMAO in Plasma and Urine in Subjects with and Metabolic Subjects

NCT06660251 | Completed

• 1 other identifier: 2019-04354
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate in subjects with and without metabolic syndrome how meals of choline- and carnitine-rich foods (eggs and meat) affect the trimethylamine-N-oxide (TMAO) concentration in blood and urine in relation to the gut microbiota composition. In response to the subjects´ gut microbiota, the concentrations of TMAO in the plasma and urine of subjects with and without metabolic syndrome (MetS) after ingesting choline- and carnitine-rich foods will be compared. On two occasions, participants will receive after overnight fasting meatballs (170 g) or three hard-boiled eggs. Blood will be collected before ingestion and over 6 hours after test food consumption.

Conditions

Metabolic Syndrome X

Keywords

Metabolic syndrome; TMAO; Gut microbiota; Egg and meat; Plasma; Urine

Outcome Measures

Primary Outcomes (2)

• TMAO and related metabolite concentrations (micromole per litre) in plasma

  TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes.

  Metabolite concentrations in plasma samples collected before ingestion of test food and after ingestion at 30, 60, 120, 240, and 360 minutes are used for calculation the incremental area under the curve.

• TMAO and related metabolite concentrations (micromole per litre) in urine

  TMAO and related metabolites (trimethylamine, betaine, choline, L-carnitine, and acetyl-L-carnitine) were analyzed by UPLC-MRM-MS in a composite urine sample collected during 6 hours post-dose.

  Post-dose sample over a 6-hours period.

Secondary Outcomes (4)

• Gut microbiota composition

  The day before the first intervention day.

• Blood glucose and glycated hemoglobin

  At screening (before intervention).

• Plasma lipid profile

  At screening (before intervention).

• Body mass index (BMI)

  At screening (before intervention).

Study Arms (2)

Subjects with MetS

ACTIVE COMPARATOR

Subjects with a minimum of three criteria according to NCEP-ATP III. Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart. Egg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.

Other: Egg intervention; Other: Meatball intervention

Subjects without MetS

ACTIVE COMPARATOR

Subjects, apparently healthy, with normal BMI, blood pressure, waist circumference (see inclusion criteria). Subjects were administered in randomized order after overnight fasting a test food. Test days were on two separate occasions around 2 weeks apart. Egg intervention: three hard-boiled eggs. Meatball intervention: 170 g meatballs.

Other: Egg intervention; Other: Meatball intervention

Interventions

Egg intervention OTHER

Oral administration of three hard-boiled eggs to be ingested within 15 minutes on one occasion.

Subjects with MetS; Subjects without MetS

Meatball intervention OTHER

Oral intervention with 170 g meatballs to be ingested within 15 minutes on one occasion.

Subjects with MetS; Subjects without MetS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age = 18-75y
• Plasma creatinine value within the age-related reference range
• No history of acute or chronic diseases (e.g. diabetes or bowel disease)
• No use of vitamin or mineral supplements, no medication with antibiotics 2 months before recruitment and during the study
• Non-smoker
• Not consuming a special diet (vegetarian)
• No pregnancy, planned conception, or lactation
• No participation in another study.
• Normal BMI (18.6 to 29.0 kg / m 2 )
• Blood counts within reference ranges
• Normal ranges for liver enzymes (P-ALAT, P-AST, P-ALP), blood status, plasma triglycerides, plasma HDL cholesterol, plasma cholesterol, plasma glucose
• A minimum of three of the following criteria according the National Cholesterol Education Program Adult Treatment Panel (NCEP-ATP III):
• Waist size \> 102 cm in men, \> 88 cm in women
• Fasting plasma glucose ≥ 5.6 mmol /l
• Triglycerides \> 1.7 mmol / l or treatment

You may not qualify if:

• Smoker
• Pregnancy, planned conception, or lactation
• Medical treatment with antibiotics 2 months before recruitment and during the study
• Use of dietary supplements 2 weeks before and during the study
• Use of probiotics 2 months before and during the study
• Following a special diet (eg vegan, vegetarian, weight loss)
• Participation in another study

Sponsors & Collaborators

• Linnaeus University: lead
• Umeå University: collaborator

Study Sites (1)

Faculty of Health and Life Sciences, Linnaeus University

Kalmar, 392 31, Sweden

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammed E Hefni, Assoc Prof

  Linnaeus University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: A randomized, crossover intervention with two active groups (subjects with and without MetS) using two test foods (egg and meat, with high content of TMAO precursors) was carried out.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 28, 2024
• Study Start: February 7, 2020
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)