NCT05939544已完成不适用
Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change-from-baseline in circulating LDL-cholesterol concentrations
研究概览
简要总结
In a randomised, controlled cross-over manner, this trial aims to determine how short-term daily supplementation with a milk fat globule membrane-enriched ingredient impacts on cardiometabolic health and cognitive outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 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
- •BMI: 25-45 kg/m2
- •Recreationally active (> 3 x 30 min moderate exercise per week)
- •Understands and is willing and able to comply with all study procedures, including changes to diet
- •Fluent in written and spoken English
- •Access to, and able to use, the internet/computer/tablet device
排除标准
- •Smoking (including vaping)
- •Unstable weight history (≥3 kg loss or gain in the previous 3 months) or planning or currently on a weight reduction scheme
- •Currently taking part or have participated in another research study in the last two months (e.g., dietary intervention)
- •Diagnosed with cardiovascular disease or suffered myocardial infarction/stroke in the past twelve months
- •Existing or significant past medical history of any medical condition likely to affect the study outcomes.
- •Prescribed medications or supplements likely to interfere with study outcomes or prescribed antibiotics within the last three months
- •Use of antidepressant/anti-anxiety medication if it has changed in the last three months or expected to change within the 3-month study period.
- •Known allergy or intolerance to study food (lactose intolerance, dairy)
- •Being vegan or any other unusual medical history or diet and lifestyle habits or practices that would preclude volunteers from participating in a dietary intervention or metabolic study
- •Excessive alcohol consumption: >21 unit/wk
- •Pregnancy, seeking to become pregnant or active lactation
结局指标
主要结局
Change-from-baseline in circulating LDL-cholesterol concentrations
时间窗: 28 days
Assessed following the collection of fasted blood samples before and after each 28-day study period
次要结局
- Change-from-baseline in glucose concentrations (determined by spectrophotometric assay)(28 days)
- Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer)(28 days)
- Change-from-baseline in cognitive test performance using a neuropsychological seven-test battery which assesses global and domain specific function, as determined by NeurOn software(28 days)
- Change-from-baseline in body mass (kg) using standard equipment.(28 days)
- Change-from-baseline in waist circumference (cm) using standard equipment.(28 days)
- Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA)(28 days)
- Change-from-baseline in interleukin-6 concentrations (determined by ELISA)(28 days)
- Change-from-baseline in insulin concentrations (determined by ELISA)(28 days)
- Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform)(28 days)
- Change-from-baseline in particle size of lipoprotein subclasses, and concentrations of particles within each subclass by high-throughput 1H-NMR metabolomics platform(28 days)
- Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry)(28 days)
- Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5])(28 days)
- Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry)(28 days)
- Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA)(28 days)
- Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry)(28 days)
- Change-from-baseline in body fat (%) using standard equipment.(28 days)
研究者
Dr Oonagh Markey
Principal Investigator
Loughborough University
研究点 (2)
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