Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function
- Conditions
- Age-related Cognitive Decline
- Interventions
- Other: Reference berry-like productOther: Active berry product
- Registration Number
- NCT05693441
- Lead Sponsor
- Aventure AB
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Age 60-85 years.
- Capable and willing to give written informed consent.
- 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).
- Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given.
- Agree to maintain consistent dietary habits and physical activity levels for the duration of the study
- 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.
- Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.
- Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.
- Underweight (BMI <18.5).
- Significant psychiatric disorders with current symptoms.
- Type 1 diabetes, recently diagnosis of Type 2 diabetes (<12 months) or ongoing insulin treatment.
- Ongoing treatment for malignancy*.
- Significant change in medication over the last 3 months.
- Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.
- Blood donation before (3 months) or during the study period.
- Planned major intervention in health care or change in medication over the next 3 months (study period).
- Currently active smoker or regular use of other nicotine products.
- Drug or alcohol abuse.
- 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).
- Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).
- Vegetarians / vegans.
- 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.).
- 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).
- Planned longer absence/vacation during the next 3 months (study period).
- Sharing household with someone participating in the current study
- Concurrent participation in other clinical intervention trials (dietary/pharmacological).
- Other reasons that make the SD in consultation with the PI deem the person inappropriate to include. *basalioma exempt from exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reference berry-like product Reference berry-like product Once daily consumption over the period of the study Active berry product Active berry product Once daily consumption over the period of the study
- Primary Outcome Measures
Name Time Method Cognitive measures-memory Change from baseline following 12 weeks daily consumption, compared to control Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test
Cognitive measures - executive function Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency
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 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 - 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 SDPT (symbol digits processing test).
- Secondary Outcome Measures
Name Time Method 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.
Body composition Change from baseline following 12 weeks daily consumption, compared to control Waist circumference (cm)
Biomarkers of glycemia Change from baseline following 12 weeks daily consumption, compared to control Fructosamine levels in blood
Biomarkers of lipemia in blood plasma Difference from baseline vs control following 12 weeks of daily consumption ApoB/A1
Biomarker endothelial function in blood plasma Difference from baseline vs control following 12 weeks of daily consumption sVCAM-1
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)
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 Heart rate (HR)
Biomarkers of liver function in blood plasma Difference from baseline vs control following 12 weeks of daily consumption ALAT
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.
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.
Biomarkers of inflammation and oxidative stress blood plasma Difference from baseline vs control following 12 weeks of daily consumption acute phase proteins (C-reactive protein)
Trial Locations
- Locations (1)
Aventure AB
🇸🇪Lund, Sweden