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| Name | Class |
|---|---|
| Berry Lab AB | UNKNOWN |
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The aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters.
The study will be conducted with a randomized, double-blind, parallel-group (2 arms) placebo-controlled, single-center interventional design. The aim is to investigate the effects on cognitive function and cardiometabolic risk markers after acute and 12 weeks daily intake of a berry product vs. a reference product. The reference will be isocaloric and matched in taste, appearance, volume and macronutrient composition to the active berry product.
Two groups, each of 30 volunteers, are studied. One group of volunteers will consume the berry product while the other group act as control and will consume the reference product.
Each volunteer will be seen for a screening visit as well as one pre- and one post-intervention visit at the clinic. In addition, there will be 2 follow-up calls in between visits. Pre- and post intervention visits will include cognitive assessment with the CANTAB battery (episodic memory and verbal recognition memory), as well as additional cognitive and behavioral tests. Cardiometabolic parameters will be addressed (plasma glucose, insulin, inflammatory markers, blood lipids, body composition) and fecal samples collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active berry product | Active Comparator | Once daily consumption over the period of the study |
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| Reference berry-like product | Placebo Comparator | Once daily consumption over the period of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active berry product | Other | Subjects should consume the active product containing nordic berries daily during the 12 week intervention period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cognitive measures-memory | Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test. | Change from baseline following 12 weeks daily consumption, compared to control |
| Cognitive measures-memory | Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test | Change from baseline following 12 weeks daily consumption, compared to control |
| Cognitive measures - memory | Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test. | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures - memory | Working memory - assessed using computerized cognitive battery including SDPT (symbol digits processing test). | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures - executive function | Executive function - assessed using computerized cognitive battery including TMT (trail making test) A & B. | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures - executive function | Executive function - assessed using computerized cognitive battery including PASAT (paced auditory serial addition test). | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Measure | Description | Time Frame |
|---|---|---|
| Circulating plasma biomarkers relating to cognitive function | Brain derived neurotrophic factor (BDNF) | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Mood measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition | Sequencing of fecal samples | Difference from baseline vs control following 12 weeks of daily consumption |
| Gut function | Questionnaire on gut function. The subject is asked to grade the frequency of symtomps of bloating, flatulence, abdominal pain and cramping, constipation and defecation pain, on a scale from 0 (never) to 3 (frequently). |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aventure AB | Lund | Sweden |
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| Reference berry-like product | Other | Subjects should consume a reference product (isocaloric to active product, containing berry aromas and colouring but no actual berry compounds) daily during the 12 week intervention period. |
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| Cognitive measures - executive function | Executive function - assessed using computerized cognitive battery including Stroop test. | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures - executive function | Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures - attention | Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test. | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cognitive measures | Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
assessed using SCAS (the Swedish Core Affect Scale) mood questionnaire. A validated self-report measure of affective state. The SCAS comprises of 12 affective states that subjects rate on a scale from 1 - 10.
| Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Self-reported quality of life | assessed using the quality of life scale from the EQ-5D (EuroQol 5 Dimension) self-report survey. The subject grades their current overall quality of life on a scale 0-100. | Difference from baseline vs control following 12 weeks of daily consumption |
| Well-being measurement | Assessed with World Health Organization- Five Well-Being Index (WHO-5). A validated 5 item scale for self-reporting levels of perceived well-being over the last two weeks. Items are rated using a 5-point scale. | Difference from baseline vs control following 12 weeks of daily consumption |
| Subjective memory | Assessed using 3 simple questions about the subject's own memory evaluation. The subject is asked to rate their memory function (scale 0 to 7), how they percieve their own memory is working compared to others in the same age (0 to 5) and if anyone close to them has expressed concern over the subjects' memory | Difference from baseline vs control following 12 weeks of daily consumption |
| Cardiometabolic risk factor | blood pressure (SBP) | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cardiometabolic risk factor | blood pressure (DBP) | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Cardiometabolic risk factor | Heart rate (HR) | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Body composition | Body weight (kg) | Change from baseline following 12 weeks daily consumption, compared to control |
| Body composition | Body mass index (BMI) (e.g., weight (kg) and height (m) will be combined to report BMI in kg/m^2). | Change from baseline following 12 weeks daily consumption, compared to control |
| Body composition | body fat % (measured by bioelectrical impedance analysis) | Change from baseline following 12 weeks daily consumption, compared to control |
| Body composition | Waist circumference (cm) | Change from baseline following 12 weeks daily consumption, compared to control |
| Biomarkers of glycemia | glucose levels in blood | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Biomarkers of glycemia | insulin levels in blood | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control |
| Biomarkers of glycemia | HOMA-IR (insulin resistance index, calculated based on fasting glucose and insulin levels) | Change from baseline following 12 weeks daily consumption, compared to control |
| Biomarkers of glycemia | Fructosamine levels in blood | Change from baseline following 12 weeks daily consumption, compared to control |
| Biomarkers of lipemia in blood plasma | triacylglycerols | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of lipemia in blood plasma | total cholesterol | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of lipemia in blood plasma | HDL-cholesterol | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of lipemia in blood plasma | LDL-cholesterol | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of lipemia in blood plasma | ApoB/A1 | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarker endothelial function in blood plasma | sVCAM-1 | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of liver function in blood plasma | ALAT | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of inflammation and oxidative stress blood plasma | Interleukin | Difference from baseline vs control following 12 weeks of daily consumption |
| Biomarkers of inflammation and oxidative stress blood plasma | acute phase proteins (C-reactive protein) | Difference from baseline vs control following 12 weeks of daily consumption |
| Difference from baseline vs control following 12 weeks of daily consumption |
| Untargeted plasma metabolome | Untargeted plasma metabolomics will be employed to exploratively assess alterations in metabolites and to identify metabolites that increase or change with berry consumption | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with gender | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with age | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with sex | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with dietary habits | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with education level | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Explorative subgroup analyses (interactions) | Data analyses of how effects on the primary outcome (cognition) interacts with intake of permitted medications | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption |
| Adverse events | Unexpected health problems and safety outcomes. | Through study completion (12 weeks) |