Cholesterol, ElevatedNCT07351175
Investigating The Potential Of A Hay-Aged Cheese To Reduce Cholesterol As Mediated By Changes In The Gut Microbiome
A study testing Hay-aged cheese in people with Cholesterol, Elevated, run by Anisha Wijeyesekera at 1 site in United Kingdom.
Trial summary
The goal of this intervention trial is to investigate the potential of an artisan cheese aged in hay to induce changes in the gut microbiota in a manner which mediates a reduction in total cholesterol in participants with elevated total cholesterol. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cholesterol, Elevated
- What is being tested?
- Hay-aged cheese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Jan 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 65 years old
- Regular consumer of cheese
- In generally good health but with total cholesterol level between 5-7.5 mmol/l and body mass index (BMI) between 18-32 kg/m2 at screening visit
- Willing and able to comply with study instructions
Who cannot join
- Use of antibiotics in the last 6 months prior to the study.
- Use of prebiotics, probiotics, laxatives, anti-spasmodic, anti-diarrhoeals, herb supplements in the last 4 weeks prior to or during the study period.
- Any chronic gut disorders/disease such as irritable bowel syndrome, inflammatory bowel disease, etc or other conditions that might affect the gut environment e.g. coeliac disease.
- High blood pressure, anaemia, high blood lipids (total cholesterol >7.5mmol/l), or inflammatory conditions
- Taking medication for anaemia, high blood pressure, high blood lipids , inflammatory conditions or depression
- Anyone diagnosed with vitamin deficiencies, diabetes, heart disease (previous stroke or heart attack) or have a pacemaker, kidney, bowel or liver diseases, cancer or hormone abnormalities.
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- Pregnant, lactating, breast feeding or planning a pregnancy within the next 6 months
- Lost more than 3kg of body weight in the last 6 months
- Food allergies and intolerances
- Participants currently involved or will be involved in another clinical or food study in the previous 1 month
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading, Department of Food and Nutritional Sciences
Reading, RG6 6UR
About this study
Official title: Investigating The Potential Of A Hay-Aged Cheese To Reduce Cholesterol As Mediated By Changes In The Gut Microbiome: A Randomised Control Trial
The goal of this intervention trial is to investigate the potential of an artisan cheese aged in hay to induce changes in the gut microbiota in a manner which mediates a reduction in total cholesterol in participants with elevated total cholesterol. The main questions it aims to answer are:
Does daily consumption of a hay aged cheese over 12 weeks reduce total cholesterol by at least 0.5mmol/l when compared the control cheese (cheddar)? Are changes in total cholesterol level reflected in changes in gut microbiota composition and activity as measured by deoxyribonucleic acid (DNA) sequencing of stool composition and short chain fatty acid levels in urine?
Participants will be asked to consume 30g portions of cheese every day for 12 weeks. This study is conducted in parallel, with participants either allocated onto the control arm (cheddar) or intervention arm (hay-aged cheese). Blood, stool, and urine samples will be taken throughout the trial, body mass index (BMI) and blood pressure will also be measured.
Read the detailed description
Cheese production involves the use of starter culture bacteria, many of which are species with recognised probiotic potential. Additionally, the food matrix of protein and fat is thought to protect these cultures during human digestion, allowing them to reach the large intestine alive. Previous studies have indicated that cultures present in cheese can persist in the gut microbiome and exert a positive effect. Further studies have indicated that regular cheese consumption, despite having a high proportion of saturated fats, has been associated with lower cholesterol levels. This is thought to be mediated by the food matrix which reduces the release of fat during digestion, and recent work by the investigators has suggested that changes in the gut microbiota activity induced by cheese consumption may also have a role. This laboratory work has shown that cheese can boost the production of propionate (a microbially derived metabolite) in a gut model system, particularly a variety of cheese that is aged in hay (Witheridge-in-hay). Propionate in the gut is known to have a role in cholesterol regulation. The hypothesis is that cheese is a source of probiotics, and the hay on the rind of Witheridge-in-hay acts in a prebiotic manner; therefore this cheese is synbiotic and has the potential to confer multiple health benefits including reduced total cholesterol concentration mediated by a change in gut microbiota composition. In the proposed study, participants (ages 18-65, with elevated cholesterol between 5.5-7.5mmol/l) will consume a thirty-gram portion of cheese a day, either Witheridge-in-hay or cheddar as a control, for twelve weeks. Effects will be determined by collecting stool samples, urine, and blood from participants to measure bacterial composition, fermentation end products, and cholesterol levels respectively, as well as body mass index (BMI) measurements and blood pressure for further assessment of cardiovascular and weight gain effects. Samples will be collected at baseline, mid-intervention, and post-intervention.
- Conditions
- Cholesterol, Elevated
- Being tested
- Hay-aged cheese, Cheddar control
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hay-aged cheeseDietary supplement
This cheese is speculated to have both probiotic properties, from the starter cultures present in the cheese, and prebiotic properties, from the hay on the rind, making this cheese synbiotic.
Cheddar controlDietary supplement
This cheese is an industrial made cheddar, it still has potential probiotic properties due to the starter cultures used, but no prebiotic potential.
| Study group | Role | What they receive |
|---|---|---|
| Hay-aged cheese | Experimental | An artisan cheese aged in hay - this is a semi-hard cheese, aged for 9 months, with hay present on the rind. Receives: Dietary Supplement: Hay-aged cheese |
| Cheddar | Active comparator | Industrial made cheddar, vintage aged. Vacuum packed. Receives: Dietary Supplement: Cheddar control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total cholesterol concentration
Total cholesterol levels will be measured at the beginning and end of the trial. Does the daily consumption of cheese have an effect on total cholesterol levels, and does consumption of a hay-aged cheese influence total cholesterol beyond that for cheddar?
Measured: 12 weeks
Secondary outcomes (3)
Change in faecal microbiota composition
Stool samples will be collected on 3 occasions throughout the trial. DNA sequencing will be used to assess changes in microbial populations in response to daily cheese consumption, comparing cheddar and the hay-aged cheese.
Measured: 12 weeks
Change in production of metabolites by the gut microbiota
1H-NMR will be used for untargeted analysis of metabolic content in stool and urine, collected on 3 and 5 occasions throughout the trial, respectively. This will help to assess the activity of the gut microbiota induced by the cheese intervention.
Measured: 12 weeks
Change in fermentation end products
Use of 1H-NMR to measure fermentation end products present in the urine and plasma.
Measured: From the first study visit to the last, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start26 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol, ElevatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anisha Wijeyesekera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anisha Wijeyesekera, University of Reading
- Investigators
- Anisha Wijeyesekera, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07351175
- Sponsor's protocol ID
- UREC 25/39
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No