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

NCT06518343 | Active Not Recruiting

• 2 other identifiers: QIB01/2024336410
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Trimethylamine N-oxide (TMAO) is produced in some individuals whose diets include meat, fish, and dairy.These foods are rich in L-carnitine. L-carnitine is metabolised by the liver and gut microorganisms (bacteria) into TMAO. In the TESSA study, investigators will explore whether pomegranate extract can lower the production of TMAO in healthy men and women. This reduction in TMAO production has been associated with decreasing a person's risk of heart disease.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  Comparison of AUC of blood plasma TMAO concentrations after L-carnitine with pomegranate extract and after L-carnitine with microcrystalline cellulose interventions.

  Day 2,3,4,16,17,and 18

Secondary Outcomes (11)

• Changes in area under the curve (AUC) from plasma concentrations of L-carnitine and its metabolites

  48 hours

• Change in peak plasma concentration (Cmax) of L-carnitine and its metabolites

  48 hours

• Change in the time to reach peak plasma concentration (Tmax) of L-carnitine and its metabolites

  48 hours

• Change in plasma half-life (t1/2) of L-carnitine and its metabolites

  48 hours

• Change in the area under the curve (AUC) from urine concentrations of L-carnitine and its metabolites

  48 hours

Study Arms (2)

Pomegranate extract

EXPERIMENTAL

1.5 grams L-carnitine (Carnipure®) + 1.6 grams pomegranate extract (Dermogranate®) in hydroxypropyl methylcellulose (HPMC) capsules

Dietary Supplement: L-carnitine + Pomegranate extract

Microcrystalline cellulose

PLACEBO COMPARATOR

1.5 grams L-carnitine (Carnipure®) + 1.5 grams microcrystalline cellulose (MCC, Redwells Health) in hydroxypropyl methylcellulose (HPMC) capsules

Dietary Supplement: L-carnitine + Microcrystalline cellulose

Interventions

L-carnitine + Pomegranate extract DIETARY_SUPPLEMENT

Participants will consume 1.5 grams L-carnitine with 1.6 grams pomegranate extract at one visit during one intervention period

Pomegranate extract

L-carnitine + Microcrystalline cellulose DIETARY_SUPPLEMENT

Participants will consume 1.5 grams L-carnitine with 1.5 grams microcrystalline cellulose at one visit during one intervention period

Microcrystalline cellulose

Eligibility Criteria

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

You may qualify if:

• 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.
• TMAO producer (plasma TMAO increase of \>5 µM and \>50% after L-carnitine ingestion.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead
• Norfolk and Norwich University Hospitals NHS Foundation Trust: collaborator
• Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK): collaborator

Study Sites (1)

Quadram Institute

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

MeSH Terms

Interventions

Carnitine; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Paul Kroon, PhD

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind masking
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover Assignment

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)