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

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Active berry product
Reference berry-like product
Sponsored by
Aventure AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Age-related Cognitive Decline focused on measuring cognitive function, memory

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Aventure AB

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active berry product

Reference berry-like product

Arm Description

Once daily consumption over the period of the study

Once daily consumption over the period of the study

Outcomes

Primary Outcome Measures

Cognitive measures-memory
Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.
Cognitive measures-memory
Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test
Cognitive measures - memory
Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test.
Cognitive measures - memory
Working memory - assessed using computerized cognitive battery including SDPT (symbol digits processing test).
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including TMT (trail making test) A & B.
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including PASAT (paced auditory serial addition test).
Cognitive measures - executive function
Executive function - assessed using computerized cognitive battery including Stroop test.
Cognitive measures - executive function
Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency
Cognitive measures - attention
Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.
Cognitive measures
Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes

Secondary Outcome Measures

Circulating plasma biomarkers relating to cognitive function
Brain derived neurotrophic factor (BDNF)
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.
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.
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.
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
Cardiometabolic risk factor
blood pressure (SBP)
Cardiometabolic risk factor
blood pressure (DBP)
Cardiometabolic risk factor
Heart rate (HR)
Body composition
Body weight (kg)
Body composition
Body mass index (BMI) (e.g., weight (kg) and height (m) will be combined to report BMI in kg/m^2).
Body composition
body fat % (measured by bioelectrical impedance analysis)
Body composition
Waist circumference (cm)
Biomarkers of glycemia
glucose levels in blood
Biomarkers of glycemia
insulin levels in blood
Biomarkers of glycemia
HOMA-IR (insulin resistance index, calculated based on fasting glucose and insulin levels)
Biomarkers of glycemia
Fructosamine levels in blood
Biomarkers of lipemia in blood plasma
triacylglycerols
Biomarkers of lipemia in blood plasma
total cholesterol
Biomarkers of lipemia in blood plasma
HDL-cholesterol
Biomarkers of lipemia in blood plasma
LDL-cholesterol
Biomarkers of lipemia in blood plasma
ApoB/A1
Biomarker endothelial function in blood plasma
sVCAM-1
Biomarkers of liver function in blood plasma
ALAT
Biomarkers of inflammation and oxidative stress blood plasma
Interleukin
Biomarkers of inflammation and oxidative stress blood plasma
acute phase proteins (C-reactive protein)

Full Information

First Posted
November 17, 2022
Last Updated
July 4, 2023
Sponsor
Aventure AB
Collaborators
Berry Lab AB
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1. Study Identification

Unique Protocol Identification Number
NCT05693441
Brief Title
Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function
Acronym
SCANBerry
Official Title
Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome: A Randomized, Double-blind, Placebo-controlled Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
June 22, 2023 (Actual)
Study Completion Date
June 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aventure AB
Collaborators
Berry Lab AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline
Keywords
cognitive function, memory

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active berry product
Arm Type
Active Comparator
Arm Description
Once daily consumption over the period of the study
Arm Title
Reference berry-like product
Arm Type
Placebo Comparator
Arm Description
Once daily consumption over the period of the study
Intervention Type
Other
Intervention Name(s)
Active berry product
Intervention Description
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
Intervention Type
Other
Intervention Name(s)
Reference berry-like product
Other Intervention Name(s)
Inactive control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive measures-memory
Description
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
Title
Cognitive measures-memory
Description
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
Title
Cognitive measures - memory
Description
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
Title
Cognitive measures - memory
Description
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
Title
Cognitive measures - executive function
Description
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
Title
Cognitive measures - executive function
Description
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
Title
Cognitive measures - executive function
Description
Executive function - assessed using computerized cognitive battery including Stroop test.
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Cognitive measures - executive function
Description
Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Cognitive measures - attention
Description
Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Cognitive measures
Description
Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary Outcome Measure Information:
Title
Circulating plasma biomarkers relating to cognitive function
Description
Brain derived neurotrophic factor (BDNF)
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Mood measurement
Description
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
Title
Self-reported quality of life
Description
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
Title
Well-being measurement
Description
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
Title
Subjective memory
Description
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
Title
Cardiometabolic risk factor
Description
blood pressure (SBP)
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Cardiometabolic risk factor
Description
blood pressure (DBP)
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Cardiometabolic risk factor
Description
Heart rate (HR)
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Body composition
Description
Body weight (kg)
Time Frame
Change from baseline following 12 weeks daily consumption, compared to control
Title
Body composition
Description
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
Title
Body composition
Description
body fat % (measured by bioelectrical impedance analysis)
Time Frame
Change from baseline following 12 weeks daily consumption, compared to control
Title
Body composition
Description
Waist circumference (cm)
Time Frame
Change from baseline following 12 weeks daily consumption, compared to control
Title
Biomarkers of glycemia
Description
glucose levels in blood
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Biomarkers of glycemia
Description
insulin levels in blood
Time Frame
Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Title
Biomarkers of glycemia
Description
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
Title
Biomarkers of glycemia
Description
Fructosamine levels in blood
Time Frame
Change from baseline following 12 weeks daily consumption, compared to control
Title
Biomarkers of lipemia in blood plasma
Description
triacylglycerols
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of lipemia in blood plasma
Description
total cholesterol
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of lipemia in blood plasma
Description
HDL-cholesterol
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of lipemia in blood plasma
Description
LDL-cholesterol
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of lipemia in blood plasma
Description
ApoB/A1
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarker endothelial function in blood plasma
Description
sVCAM-1
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of liver function in blood plasma
Description
ALAT
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of inflammation and oxidative stress blood plasma
Description
Interleukin
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Biomarkers of inflammation and oxidative stress blood plasma
Description
acute phase proteins (C-reactive protein)
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Other Pre-specified Outcome Measures:
Title
Gut microbiota composition
Description
Sequencing of fecal samples
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Gut function
Description
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).
Time Frame
Difference from baseline vs control following 12 weeks of daily consumption
Title
Untargeted plasma metabolome
Description
Untargeted plasma metabolomics will be employed to exploratively assess alterations in metabolites and to identify metabolites that increase or change with berry consumption
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with gender
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with age
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with sex
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with dietary habits
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with education level
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Explorative subgroup analyses (interactions)
Description
Data analyses of how effects on the primary outcome (cognition) interacts with intake of permitted medications
Time Frame
Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Title
Adverse events
Description
Unexpected health problems and safety outcomes.
Time Frame
Through study completion (12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Aventure AB
City
Lund
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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

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