An interventional study of Hay-aged cheese and Cheddar control in Cholesterol, Elevated, sponsored by Anisha Wijeyesekera. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Anisha Wijeyesekera · Not applicable, Interventional, and Health services research
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.
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.
Exclusion Criteria:
An artisan cheese aged in hay - this is a semi-hard cheese, aged for 9 months, with hay present on the rind.
Dietary Supplement: Hay-aged cheese
Industrial made cheddar, vintage aged. Vacuum packed.
Dietary Supplement: Cheddar control
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.
This cheese is an industrial made cheddar, it still has potential probiotic properties due to the starter cultures used, but no prebiotic potential.
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?
Time frame: 12 weeks
Change in faecal microbiota composition
Stool samples will be collected on 3 occasions throughout the trial. 16S sequencing will be used to assess changes in microbial populations in response to daily cheese consumption, comparing cheddar and the hay-aged cheese.
Time frame: 12 weeks
Change in production of SCFA by the gut microbiota
Gas chromatography will be used to analyse changes in SCFA 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.
Time frame: 12 weeks
Plan to share: No
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