Active not recruitingNAINTERVENTIONAL

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

The TESSA study is exploring if pomegranate extract can help lower a substance called TMAO in healthy men and women. TMAO is naturally produced in your body when you eat foods rich in L-carnitine, like meat, fish, and dairy. Some studies suggest that high levels of TMAO could increase the risk of heart problems. This research aims to understand if taking a pomegranate supplement at the same time as L-carnitine can reduce how much TMAO your body makes. It's an important step to see if simple dietary additions might have health benefits for your heart. Participants will be healthy adults who regularly eat these types of foods and live near Norwich.

At a glance

Status

Active not recruiting

Phase

Sponsor

Quadram Institute Bioscience

Enrolment target

Start

12 Aug 2024

Estimated completion

31 May 2027

Healthy

What is this study about?

You know how some foods like meat, fish, and dairy are important parts of many diets? Well, when your body breaks down some of the natural ingredients in these foods, it can produce a substance called TMAO. Some research hints that having too much TMAO in your system might not be good for your heart health.

This study, called TESSA, wants to find out if eating pomegranate can help reduce the amount of TMAO your body makes. Pomegranate is known for its health benefits, and researchers are curious if it can specifically help your body process these foods in a way that creates less TMAO. It’s a pilot study, meaning it’s a smaller, early step to see if this idea works before potentially doing bigger studies.

The TESSA study is specifically looking for healthy men and women who regularly eat meat, fish, or eggs. They want to see if adding a pomegranate extract to their diet can make a difference compared to a dummy pill (placebo). If pomegranate can indeed lower TMAO levels, it could open doors for new ways to support heart health through diet.

Key takeaways

Study examines if pomegranate extract can lower TMAO levels.
TMAO is linked to eating meat, fish, and dairy, and may affect heart health.
Looking for healthy adults who regularly eat these foods.
Involves taking capsules and providing blood, urine, and stool samples.
Requires living near Norwich and regular meat/fish/egg consumption.
Participation includes following a controlled diet for part of the study.

Who may be eligible?

To join this study, you need to be a healthy man or woman over 18 years old. You should regularly eat meat, fish, or eggs – at least four portions of meat a week for the past two months. Your body mass index (BMI) should be between 18.5 and 30, and you also need to live within 40 miles of the Norwich Research Park.

There are also some specific health checks. For example, you shouldn't be a smoker, pregnant or breastfeeding. You shouldn't have certain health conditions like diabetes, kidney, or liver disease, or high or low blood pressure. It's also important that you don't have allergies to ingredients in the study capsules or meals, and you must be able to swallow four capsules and three tablets easily.

After an initial check, if you produce enough TMAO in your body and meet all other requirements, you might be invited to continue with the main part of the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 years old?
Do you regularly eat meat, fish, or eggs (at least 4 portions of meat per week)?
Is your Body Mass Index (BMI) between 18.5 and 30?
Do you live within 40 miles of the Norwich Research Park?
Can you swallow four capsules and three tablets easily?
Are you a non-smoker and not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join the study, it will be in two main parts. In the first part, you'll have two visits. During one visit, you'll take three L-carnitine capsules. The researchers will check your blood to see how much TMAO your body makes. They’ll also ask you about your usual diet.

If you're invited to the second part, it involves two intervention periods, each separated by a 10-day break where you won't take any study capsules. For each intervention period, you’ll first have a run-in phase, then three more study visits. Throughout this second part, you'll follow a special, controlled diet which will be provided, and you'll switch between taking L-carnitine capsules with a pomegranate extract or L-carnitine capsules with a dummy pill. This means you’ll try both the pomegranate and the dummy pill at different times. At these visits, you’ll take the capsules, and they will collect blood samples to measure L-carnitine and TMAO levels, as well as urine and stool samples to understand how your body processes everything. The total duration of your active participation, once you start the second phase, will involve several visits over a few weeks, with a 10-day break in between.

Potential risks and benefits

Taking part in a study like this helps researchers learn more about how our bodies work, which could eventually lead to new ways to support health. You wouldn't directly benefit from the pomegranate extract, as it's a research study. However, some blood tests might tell you about your general health. Potential risks might include discomfort from blood tests or slight stomach upset from the capsules. You can stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quadram Institute
Verified postcode
Norwich, United Kingdom

Common questions

What is TMAO?

TMAO is a substance your body makes when it digests certain foods, like meat and dairy. Some studies link higher levels of TMAO to potential heart health concerns.

What is L-carnitine?

L-carnitine is a natural substance found in foods like meat, fish, and dairy, and it plays a role in how your body produces energy.

What is a 'placebo'?

A placebo is a dummy pill that looks just like the real treatment but contains no active ingredients. It helps researchers compare the effects of the actual treatment.

Will I know if I'm getting pomegranate or the dummy pill?

No, this is a 'double-blind' study, meaning neither you nor the study staff will know which capsule you are receiving, to keep the results unbiased.

Will I get free meals?

Yes, if you continue to the second phase of the study, you will be provided with standardized meals to follow a controlled diet for certain periods.