Investigating The Potential Of A Hay-Aged Cheese To Reduce Cholesterol As Mediated By Changes In The Gut Microbiome
Recruiting · NCT07351175 · Interventional (participants receive a specific treatment) · Lead sponsor: Anisha Wijeyesekera
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- University of Reading, Department of Food and Nutritional Sciences - Reading, United Kingdom