Impact of Short-term Supplementation with a Milk Fat Globule Membrane-enriched Powdered Ingredient on Cardiometabolic and Cognitive Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 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
研究组 & 干预措施
Milk Fat Globule Membrane-enriched Powdered Ingredient
Participants will be provided with pre-weighed, foil sachets containing a ready-to-mix flavoured powdered supplement that is rich in milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
干预措施: Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient (Dietary Supplement)
Control (Placebo) Powdered Ingredient
Participants will be provided with pre-weighed, foil sachets containing an energy- and macronutrient-matched ready-to-mix powdered placebo supplement that is devoid of milk fat globule membrane (and associated complex milk lipids). They will be asked to consume two sachets daily (mixed with water) during the 4-week study period. Sachets will be coded to maintain study blinding.
干预措施: Placebo Comparator: Control (Placebo) Powdered Ingredient (Dietary Supplement)
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 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 forearm blood flow, as assessed by venous occlusion plethysmography (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