Investigating The Potential Of A Hay-Aged Cheese To Reduce Cholesterol As Mediated By Changes In The Gut Microbiome

February 10, 2026 updated by: Anisha Wijeyesekera

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants aged 18 to 65 years old
  • Regular consumer of cheese
  • In generally good health but with total cholesterol level between 5.5-7.5 mmol/l and body mass index (BMI) between 18-32 kg/m2 at screening visit
  • Willing and able to comply with study instructions

Exclusion Criteria:

  • 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.
  • Pregnant, lactating, breast feeding or planning a pregnancy within the next 6 months
  • Peri- or postmenopausal women
  • 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 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hay-aged cheese
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
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.
Active Comparator: Cheddar
Industrial made cheddar, vintage aged. Vacuum packed.
Dietary supplement: Cheddar control
This cheese is an industrial made cheddar, it still has potential probiotic properties due to the starter cultures used, but no prebiotic potential.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total cholesterol concentration
Time Frame: 12 weeks
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?
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in faecal microbiota composition
Time Frame: 12 weeks
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.
12 weeks
Change in production of SCFA by the gut microbiota
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anisha Wijeyesekera

Investigators

  • Principal Investigator: Anisha Wijeyesekera, University of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 2, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UREC 25/39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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