What you'll do

You’ll be asked to follow a ketogenic diet and take a daily supplement for 12 weeks.

You’ll attend a screening visit on our University of Bath campus to check and confirm your eligibility. We will then provide you with equipment to assess your usual diet and physical activity, as well as continuous monitors to measure your normal glucose and ketone levels.

After one to two weeks, you will be invited to the main trial day. This will include various measurements, including blood and fat samples and a DEXA scan. You will also be asked to provide a stool sample.

After this, you’ll be randomly assigned to one of two groups: one group receiving a supplement containing an active ingredient, and the other a placebo.

Before, during and after the ketogenic diet and supplementation period, we will take blood and fat samples. Throughout the study, we will monitor your glucose, ketone and physical activity levels, as well as your diet.

Eligibility

We are looking for approximately 64 men and women between 18 and 65 years old who are interested in trying a ketogenic diet.

To take part in this study, you must be committed to adopting a ketogenic diet for the duration of the study.

You can not take part in the study if you:

• have been diagnosed with Type 2 Diabetes, or any heart, liver or kidney conditions
• use medication that lowers cholesterol
• have used antibiotics in the last 3 months
• follow a vegetarian, vegan or ketogenic diet
• use tobacco products or vape
• are pregnant or are planning to become pregnant

What you'll get for taking part

On successful completion of this 12‑week research study, you'll receive a £200 Love2Shop voucher. We will cover all reasonable travel expenses, provide free parking for your visits to our campus, and give you a small daily allowance to help you offset the cost of buying groceries to suit a ketogenic diet.

By participating in this study, you'll contribute to science and to our understanding of how ketogenic diets affect cholesterol and help us determine whether a synbiotic supplement is useful for preventing an increase in LDL cholesterol. This could help the millions of people who choose ketogenic diets and support clinicians who recommend them to their patients.

You will be given a copy of some of your results at the end of the study. These will cover:

• Physical activity levels
• Blood pressure
• Body composition analysis from the DEXA scan (the amount of muscle and fat that you have and your bone density)
• Cognitive performance

Your data

All data will be pseudonymised, which means that no one outside the research team will be able to see your actual name or contact details. Your data will be assigned a code number instead. We will keep all information about you safe and secure.

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that ensures nobody can identify you as a participant.

Ethical approval

Relevant ethics approval information:

• IRAS ID: 363636
• REC reference: 25/WA/0351