Trimethylamine N-oxide Effects of a Pomegranate Supplement Simultaneously With Carnitine (TESSA)

Recruitment & Eligibility

Status: Enrolling by invitation

Sex: All

Target Recruitment: 40

Inclusion Criteria

Inclusion criteria (First phase): - Individuals who regularly eat meat (4 portions of meat per week for at least 2 months prior to enrolment in the study). - Aged 18 and older. - Body Mass Index (BMI) between 18.5 - 30 kg/m2. - Living within 40 miles from the Norwich Research Park. Inclusion criteria (Second phase) - meets first phase inclusion criteria - TMAO producer (plasma TMAO increase of >5 µM and >50% after L-carnitine ingestion. Exclusion criteria: - Consume an entirely vegan, vegetarian, or pescatarian diet within the last two months. - Do not have access to a freezer to store some provided meals and ice packs. - Have a known allergy to the tablets, capsules (i.e., pomegranate), or standardised meals such as wheat, eggs, milk, nuts, and soybeans. - Have difficulty swallowing, a swallowing disorder, or are unable to swallow four capsules (the size of a peanut) and three L carnitine tablets consecutively within a time span of ten minutes. - Have bowel movements less than five times a week. - Are a current smoker (or stopped smoking for less than 3 months). - Consume more than 14 units of alcohol per week (for example, a pint of beer or a 175 mL glass of wine each count as two units). - Are pregnant or breastfeeding. - Have anaemia or any conditions or medications that may hinder clotting. This will be assessed on a case-by-case basis. - Have high or low blood pressure (i.e., =90/60 or =160/100 mmHg). - Have a medical condition or take medications that may affect the primary outcome of this study, such as but not limited to diabetes, liver disease, hypo/hyperthyroidism, or fish odour syndrome. This will be assessed on a case-by-case basis. - Have had gastrointestinal disease or surgical procedures that may affect the primary outcome of this study. This will be assessed on a case-by-case basis. - Have known or a history of kidney disease, this will be determined by the medical advisor using blood urea nitrogen and creatinine levels in the participant's blood. - Regularly use bowel cleansing techniques like colonic irrigation or laxatives. - Had an infection or received antibiotics within a month prior to this study. - Regularly take dietary supplements that may affect the primary outcome measure of this study, such as fish oil or L carnitine supplements. - Are currently undergoing active treatment for cancer or heart disease. - Participated in another dietary intervention study within the last four months. - Have donated a large quantity of blood within the last 16 weeks. Registered donors should abstain from blood donations for the duration of the study. - Are a person related to or living with a member of the study team. - Are unable to give written or verbal informed consent. - Participant is unable to provide GP (General Practitioner) contact details. - Have symptoms of Coronavirus infection (COVID-19), been asked to self-isolate, or have been diagnosed with COVID-19 in the last 14 days.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in the area under the curve (AUC) of blood plasma TMAO concentrations after pomegranate extract and microcrystalline cellulose interventions.

Secondary Outcome Measures