Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function

Aventure AB62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Age-related Cognitive Decline

Interventions

Active berry productOTHER

Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.

Reference berry-like productOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 exclusion criteria

Locations (1)

Aventure AB

Lund, Sweden

Outcomes

Primary Outcomes

Cognitive measures-memory

Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.

Time frame: 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

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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).

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Cognitive measures - executive function

Data from ClinicalTrials.gov

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Secondary Outcomes

Circulating plasma biomarkers relating to cognitive function

Brain derived neurotrophic factor (BDNF)

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Mood measurement

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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Cardiometabolic risk factor

blood pressure (SBP)

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Cardiometabolic risk factor

blood pressure (DBP)

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Cardiometabolic risk factor

Heart rate (HR)

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Body composition

Body weight (kg)

Time frame: 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).

Time frame: Change from baseline following 12 weeks daily consumption, compared to control

Body composition

body fat % (measured by bioelectrical impedance analysis)

Time frame: Change from baseline following 12 weeks daily consumption, compared to control

Body composition

Waist circumference (cm)

Time frame: Change from baseline following 12 weeks daily consumption, compared to control

Biomarkers of glycemia

glucose levels in blood

Time frame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Biomarkers of glycemia

insulin levels in blood

Time frame: 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)

Time frame: Change from baseline following 12 weeks daily consumption, compared to control

Biomarkers of glycemia

Fructosamine levels in blood

Time frame: Change from baseline following 12 weeks daily consumption, compared to control

Biomarkers of lipemia in blood plasma

triacylglycerols

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of lipemia in blood plasma

total cholesterol

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of lipemia in blood plasma

HDL-cholesterol

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of lipemia in blood plasma

LDL-cholesterol

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of lipemia in blood plasma

ApoB/A1

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarker endothelial function in blood plasma

sVCAM-1

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of liver function in blood plasma

ALAT

Time frame: Difference from baseline vs control following 12 weeks of daily consumption

Biomarkers of inflammation and oxidative stress blood plasma

Interleukin

Time frame: 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)

Time frame: Difference from baseline vs control following 12 weeks of daily consumption