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

NCT07351175 | Recruiting DMC

• 1 other identifier: UREC 25/39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cholesterol, Elevated

Outcome Measures

Primary Outcomes (1)

• 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?

  12 weeks

Secondary Outcomes (2)

• Change in faecal microbiota composition

  12 weeks

• Change in production of SCFA by the gut microbiota

  12 weeks

Study Arms (2)

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.

Dietary Supplement: Hay-aged cheese

Cheddar

ACTIVE COMPARATOR

Industrial made cheddar, vintage aged. Vacuum packed.

Dietary Supplement: Cheddar control

Interventions

Hay-aged cheese DIETARY_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.

Hay-aged cheese

Cheddar control DIETARY_SUPPLEMENT

This cheese is an industrial made cheddar, it still has potential probiotic properties due to the starter cultures used, but no prebiotic potential.

Cheddar

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anisha Wijeyesekera: lead

Study Sites (1)

University of Reading, Department of Food and Nutritional Sciences

Reading, RG6 6UR, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Anisha Wijeyesekera

  University of Reading

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabrina I Longley

CONTACT

+44 7587142910; s.i.c.longley@pgr.reading.ac.uk

Anisha Wijeyesekera

CONTACT

a.wijeyesekera@reading.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told which cheese they have been allocated, but the appearance of the cheese (hay-aged vs cheddar) will likely make it obvious to the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 2, 2026
• First Posted: January 20, 2026
• Study Start: January 26, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)