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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk Fat Globule Membrane-enriched Powdered Ingredient | Experimental | 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. |
|
| Control (Placebo) Powdered Ingredient | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: Milk Fat Globule Membrane-enriched Powdered Ingredient | Dietary Supplement | Milk Fat Globule Membrane-enriched Powdered Ingredient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change-from-baseline in circulating LDL-cholesterol concentrations | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change-from-baseline in circulating lipid and apolipoprotein concentrations (measured using a spectrophotometric assay or high-throughput 1H-NMR metabolomics platform) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loughborough University | Loughborough | LE11 3TU | United Kingdom |
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| Placebo Comparator: Control (Placebo) Powdered Ingredient | Dietary Supplement | Placebo Comparator: Control (Placebo) Powdered Ingredient |
|
Assessed following the collection of fasted blood samples before and after each 28-day study period |
| 28 days |
| Change-from-baseline in interleukin-6 concentrations (determined by ELISA) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Change-from-baseline in lipopolysaccharide-binding protein concentrations (determined by ELISA) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Change-from-baseline in selected gut-related metabolites (for example, trimethylamine N-oxide concentrations determined by mass spectrometry) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Change-from-baseline in glucose concentrations (determined by spectrophotometric assay) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Change-from-baseline in insulin concentrations (determined by ELISA) | Assessed following the collection of fasted blood samples before and after each 28-day study period | 28 days |
| Change-from-baseline in HOMA-IR (calculated as [fasting glucose (mmol/L) × fasting insulin (mIU/L)]/22.5]) | Assessed following assessment of fasting circulating glucose and insulin concentrations before and after each 28-day study period | 28 days |
| Change-from-baseline in clinic systolic and diastolic blood pressure (assessed by automated upper arm sphygmomanometer) | Assessed in the fasted state before and after each 28-day study period | 28 days |
| Change-from-baseline in arterial stiffness, as assessed by radial pulse wave analysis (using applanation tonometry) | Assessed in the fasted state before and after each 28-day study period | 28 days |
| Change-from-baseline in forearm blood flow, as assessed by venous occlusion plethysmography (using applanation tonometry) | Assessed in the fasted state before and after each 28-day study period | 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 | Assessed before and after each 28-day study period | 28 days |
| Change-from-baseline in brain-derived neurotrophic factor concentrations (determined by ELISA) | Assessed in the fasted state before and after each 28-day study period | 28 days |
| Change-from-baseline in body mass (kg) using standard equipment. | Assessed in the fasted state before and after each 28-day study period | 28 days |
| Change-from-baseline in waist circumference (cm) using standard equipment. | Assessed in the fasted state before and after each 28-day study period | 28 days |
| Change-from-baseline in body fat (%) using standard equipment. | Assessed in the fasted state before and after each 28-day study period | 28 days |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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