A Randomised, Double-blind Trial to Measure the Effects of Milk-based Drinks on Gut Microbiome, Sleep, and Cardiometabolic Markers in Adults With Poor Sleep
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- LDL Cholesterol
研究概览
简要总结
The purpose of this study is to evaluate the effects of kefir on gastrointestinal health, sleep quality, and biochemical parameters in adults who have sleep problems. Further measurements of cognitive function, arterial stiffness and blood pressure will also be assessed.
The following questions will be addressed during the study:
- What effect does repeated ingestion of kefir have on the gut microbiome and can this positively influence sleep performance (quality and duration) in adults with sleep problems?
- Does repeated ingestion of kefir impact LDL, triacyglycerols and non-HDLc in adults with sleep problems?
- What effect does repeated ingestion of kefir have on cognitive function and mood?
- What effect does repeated ingestion of kefir have on vascular function, inflammation and markers of immunity in adults with sleep problems?
In a randomised, crossover design study, participants will consume 250 ml of kefir (original flavour) or milk for 4 weeks with a 4-week washout.
详细描述
The gut microbiome is recognized as a key regulator of host health, influencing various physiological processes. Dysbiosis of the gut microbiome has been implicated in a range of adverse health outcomes, including disruptions in sleep architecture and impairments in cardiometabolic function. There is growing interest in identifying dietary interventions that can modulate gut microbiota composition and functionality. In particular, the consumption of fermented foods, such as kefir, has emerged as a potential strategy for promoting microbial homeostasis and improving health outcomes
This study conforms to a randomised, double-blind 2-arm crossover design. Participants will consume either Kefir (original flavour) or milk. Each arm will involve daily consumption of the drink for 4-weeks with a 4 week washout before crossing over to the opposite condition. Drinks will be administered in a counterbalanced order to minimise potential order effects.
The primary outcome of this study is a 5% change in LDL based on a previous study (Bellikci-Koyu et al., 2022).
Assuming type I error probability α = 0.05 and power of 80%, and effect size of 0.2 G*power calculated that 32 participants would need to be recruited.
To account for potential drop out and balanced randomization, we will aim to recruit 40 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-70 years old
- •Suffer with poor sleep (measured using the PIttsburg Sleep Quality Index with a score > 5)
- •BMI in range of 25-35 kg/m2
- •Willingness to consume each study drink daily for 4 weeks and attend the laboratory on 4 separate occasions
- •For women: Medication in the form of contraception or HRT providing these have not been modified 3 months prior to the first study day
排除标准
- •Intolerance or allergy to milk-based products
- •Pregnancy/breastfeeding
- •Insufficient English language skills to complete all study questionnaires and perform the cognitive tests
- •Gastrointestinal disorders
- •Inability to attend the laboratory due to travel/mobility difficulties
结局指标
主要结局
LDL Cholesterol
时间窗: 4-weeks
A blood sample via venepuncture will be taken at baseline and again after 4-weeks of daily consumption of the intervention or control for the assessment of LDL cholesterol. Blood samples will be obtained in a fasted state.
Gut microbiome
时间窗: 4-weeks
A stool sample will be collected from participants at baseline and after 4 weeks daily consumption of the intervention and control drink. The composition of the microbiome in stool will be measured by 16s rRNA sequencing.
Sleep quality and duration
时间窗: 4-weeks
Sleep quality and duration will be measured objectively and subjectively. For subjective measures, the Pittsburg Sleep Quality Index will be used to assess participant's sleep habits. The tool comprises of 7 sub-components and 18 items, including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction. In addition, the Epworth Sleepiness Scale. The Epworth sleepiness scale results range from 0 to 24. Participants will also wear a Fitbit Charge 2 watch to track their sleep. Sleep measures will be obtained during the 7-day run in and final week of each study intervention for a total of 4 questionnaires to be completed by each participant and 4 week of objective sleep data.
次要结局
- Blood samples(4-weeks)
- Saliva IgG(4 week)
- Cognitive function(4 weeks)
- Blood pressure(4 week)
- Pulse Wave Analysis(4 week)
研究者
Tony Lynn
Dr Anthony Lynn
Sheffield Hallam University