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too time-lengthy administrative process nationally - study no longer fits in PhD trajectory window
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In this randomized placebo controlled intervention study, the effect of 12 weeks of supplementation with either 150g whole blueberries, freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning will be investigated in older adults.
Dementia is a public health priority. The prevalence of dementia is rapidly increasing due to population ageing, posing a great social and economic impact on caregivers, families and society. This, in combination with the lack of effective treatment options, demonstrates the urgent need for better understanding on how to prevent and slow down progression of this condition. As ageing and dementia are associated with increased levels of inflammation, nutritional compounds that exhibit anti-inflammatory properties may propose a solution. Blueberries, a good source of anthocyanins, have shown anti-inflammatory properties in several human trials. Therefore, in this randomized placebo controlled intervention study, we aim to investigate the effect of 12 weeks of supplementation with either 150g whole blueberries or freeze-dried blueberry powder (dose equivalent to 150g berries) versus placebo on cognitive functioning in overweight older adults with mild memory complaints. Secondary objectives include the assessment of whole blueberry and freeze-dried blueberry powder supplementation on inflammatory markers, oxidative stress, intestinal health markers, vascular and metabolic health markers, mental well-being, and levels of neurotransmitters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole blueberries | Experimental | Participants will consume a daily dose of 150g of whole blueberries |
|
| Freeze-dried blueberry powder | Experimental | Participants will consume a daily dose of 24g freeze-dried blueberry powder, equivalent to 150g whole blueberries |
|
| Placebo powder | Placebo Comparator | Participants will consume a daily dose of 24g colour- and flavour-matched maltodextrin powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry | Other | Daily consumption of blueberries |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal fluency | Performance on verbal fluency | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive functioning | Rey Auditory Verbal Learning Test (RAVLT) | 12 weeks |
| Cognitive function | Wechsler Digit Span Task (forward, backward, sequencing) WAIS-IV |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisette de Groot, prof | Division of Human Nutrition and Health, Wageningen University and Research, The Netherlands | Principal Investigator |
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Starting 12 months after article publication. Sharing only upon reasonable request in consultation with the study team.
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Starting 12 months after article publication.
Upon reasonable request. Sharing will be done in consultation with the study team
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000721609 | blueberry extract |
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Treatment is only partly masked for the participants; blueberry freeze-dried powder and placebo treatments are masked, but whole berry treatment is not.
| Freeze-dried blueberry powder |
| Dietary Supplement |
Daily consumption of a freeze-dried blueberry powder |
|
| Placebo powder | Dietary Supplement | Daily consumption of a placebo powder |
|
| 12 weeks |
| Cognition | Symbol digit modalities test | 12 weeks |
| Cognition | Trail Making Test (TMT) version A and B | 12 weeks |
| Cognition | Stroop Color-Word test | 12 weeks |
| Inflammation - CRP | Inflammatory blood marker: C-reactive protein | 12 weeks |
| Inflammation - TNFalpha | tumor necrosis factor-alpha | 12 weeks |
| Inflammation - IL6 | interleukin-6 | 12 weeks |
| Oxidative stress | total plasma nitric oxide (NO) | 12 weeks |
| Oxidative stress | serum superoxide dismutase (SOD) | 12 weeks |
| Intestinal health | Intestinal health markers as measured in blood and feces (microbiota composition, inflammatory fecal markers, microbiota-derived bioactive compounds, intestinal integrity markers | 12 weeks |
| Metabolic health | Blood markers of metabolic health: plasma fasting glucose, | 12 weeks |
| Metabolic health | Blood markers of metabolic health (plasma fasting glucose, Hb1Ac, triglyceride, adiponectin) | 12 weeks |
| Metabolic health | Blood markers of metabolic health: Hb1Ac, | 12 weeks |
| Metabolic health | Blood markers of metabolic health: triglyceride | 12 weeks |
| Metabolic health | Blood markers of metabolic health: adiponectin | 12 weeks |
| Mental well-being | Score on 12-item short form health survey | 12 weeks |
| Mental well-being | profiles of mood states-short form (POMS) | 12 weeks |
| Neurotransmitters | Levels of plasma neurotransmitters (dopamine, serotonin, (nor)adrenaline, and their metabolites) | 12 weeks |
| Vascular health | Markers of vascular health (systolic blood pressure, diastolic blood pressure) | 12 weeks |