Age-related Cognitive Decline
Conditions
Keywords
cognitive function, memory
Brief summary
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.
Detailed description
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.
Interventions
OTHERActive berry product
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
OTHERReference berry-like product
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.
Sponsors
Berry Lab AB
Aventure AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 60-85 years. 2. Capable and willing to give written informed consent. 3. Capable and willing to perform cognitive testing in Swedish (mastering the Swedish language, functional vision and hearing or the use of visual or hearing aids during testing). 4. Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given. 5. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
Exclusion criteria
1. Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than 24. 2. Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function. 3. Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke. 4. Underweight (BMI \<18.5). 5. Significant psychiatric disorders with current symptoms. 6. Type 1 diabetes, recently diagnosis of Type 2 diabetes (\<12 months) or ongoing insulin treatment. 7. Ongoing treatment for malignancy\*. 8. Significant change in medication over the last 3 months. 9. Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study. 10. Blood donation before (3 months) or during the study period. 11. Planned major intervention in health care or change in medication over the next 3 months (study period). 12. Currently active smoker or regular use of other nicotine products. 13. Drug or alcohol abuse. 14. Conditions with major impact on the gastrointestinal tract (such as Crohn's disease, ulcerative colitis, diagnosed gluten intolerance, undertaken intestinal resection or weight loss surgery). 15. Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch). 16. Vegetarians / vegans. 17. Daily, regular high consumption (approximately 1 dl or more per day) of berries or juices / marmalade / products with high content of bilberries and lingonberries. (Can be recruited if consumption has ceased to less than 5 grams of berries per day at least 1 month before visit 1.). 18. Taking supplements with potential cognitive effects (e.g., omega-3, ginko biloba, Souvenaid), or containing grape and berry extracts or probiotics (capsules or ProViva). (Can be recruited if this intake ceases at least one month before visit 1). 19. Planned longer absence/vacation during the next 3 months (study period). 20. Sharing household with someone participating in the current study 21. Concurrent participation in other clinical intervention trials (dietary/pharmacological). 22. Other reasons that make the SD in consultation with the PI deem the person inappropriate to include. \*basalioma exempt from
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive measures - executive function | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | Executive function - assessed using computerized cognitive battery including TMT (trail making test) A & B. |
| Cognitive measures - memory | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test. |
| Cognitive measures | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes |
| Cognitive measures - attention | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test. |
| Cognitive measures-memory | Change from baseline following 12 weeks daily consumption, compared to control | Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective memory | Difference from baseline vs control following 12 weeks of daily consumption | 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 |
| Cardiometabolic risk factor | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | blood pressure (SBP) |
| Biomarkers of glycemia | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | glucose levels in blood |
| Biomarkers of lipemia in blood plasma | Difference from baseline vs control following 12 weeks of daily consumption | triacylglycerols |
| Biomarker endothelial function in blood plasma | Difference from baseline vs control following 12 weeks of daily consumption | sVCAM-1 |
| Biomarkers of liver function in blood plasma | Difference from baseline vs control following 12 weeks of daily consumption | ALAT |
| Biomarkers of inflammation and oxidative stress blood plasma | Difference from baseline vs control following 12 weeks of daily consumption | Interleukin |
| Body composition | Change from baseline following 12 weeks daily consumption, compared to control | Body weight (kg) |
| Circulating plasma biomarkers relating to cognitive function | Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control | Brain derived neurotrophic factor (BDNF) |
| Mood measurement | 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. |
| Self-reported quality of life | Difference from baseline vs control following 12 weeks of daily consumption | 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. |
| Well-being measurement | Difference from baseline vs control following 12 weeks of daily consumption | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota composition | Difference from baseline vs control following 12 weeks of daily consumption | Sequencing of fecal samples |
| Adverse events | Through study completion (12 weeks) | Unexpected health problems and safety outcomes. |
| Explorative subgroup analyses (interactions) | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption | Data analyses of how effects on the primary outcome (cognition) interacts with gender |
| Untargeted plasma metabolome | Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption | Untargeted plasma metabolomics will be employed to exploratively assess alterations in metabolites and to identify metabolites that increase or change with berry consumption |
| Gut function | Difference from baseline vs control following 12 weeks of daily consumption | 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). |
Countries
Sweden
Outcome results
None listed