Investigating The Potential Of A Hay-Aged Cheese To Reduce Cholesterol As Mediated By Changes In The Gut Microbiome: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in total cholesterol concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Hay-aged cheese (Dietary Supplement)
Cheddar
Industrial made cheddar, vintage aged. Vacuum packed.
干预措施: Cheddar control (Dietary Supplement)
结局指标
主要结局
Change in total cholesterol concentration
时间窗: 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?
次要结局
- Change in faecal microbiota composition(12 weeks)
- Change in production of SCFA by the gut microbiota(12 weeks)
研究者
Anisha Wijeyesekera
Associate Professor
University of Reading