Back to resultsEffect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment (MINDBERRY)
Primary Purpose
Cognitive Impairment, Mild, Memory Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Active berry product
Reference product
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Impairment, Mild
Eligibility Criteria
Inclusion Criteria:
- Age of 55 years or older.
- Cognitive impairment in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and global deterioration scale (GDS) stage 3.
- Capable and willing to give written informed consent.
- Capable and willing to perform cognitive testing (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.
Exclusion Criteria:
- MMSE (Mini-Mental State Examination) <24 (at screening or in the last 3 months).
- Cognitive disease (e.g. dementia) according to Global Deterioration Scale (GDS) stage 4 and up.
- Severe affective disorder with current symptoms
- Severe mental disorder.
- Newly diagnosed or poorly regulated thyroid disease (unstable dose since 3 months back).
- Ongoing insulin therapy.
- Ongoing treatment for malignancy*.
- 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).
- Planned major intervention in health care over the next 3 months (the study period).
- Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.
- Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).
- Vegetarians / vegans.
- Smoking.
- Abuse of alcohol or psychoactive substance.
- Significant change in medication over the last 3 months.
- Daily, regular high consumption of berries or juices / marmalade / product with high content of these berries (guideline no more than 5 grams per day). (Can be recruited for the study if this intake ceases before visit 1. High consumes (approximately 1 dl of berries per day) has to cease with this at least one month before visit 1.)
- Taking supplements with potential cognitive effects (e.g. omega-3, ginko biloba), or containing grape and berry extracts or probiotics (capsules or other). (Can be recruited if this intake ceases at least one month before visit 1).
- Planned longer absence/vacation during the next 3 months (the study period).
- Concurrent participation in other clinical intervention trials (dietary/pharmacological).
Other reasons that make the Study investigator in consultation with the responsible physician deem the person inappropriate to include.
- basalioma exempt from exclusion criteria.
Sites / Locations
- Cognitve medicineRecruiting
- Cognitive medicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active berry product
Reference 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
CANTAB - Paired Associate Learning test (PAL28)
To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory
Secondary Outcome Measures
Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall)
Attention, psychomotor speed and executive function (Trail making test (TMT) A and B)
Selective attention and processing speed (Stroop color-word test)
Verbal fluency (letter "S" word fluency test)
Number of novel words on letter "S" during 60 seconds.
Behavior and quality of life (AES, Apathy evaluation score (self))
Answers given by the participants on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.
Behavior and quality of life (Apathy evaluation score (informant))
Answers given by someone close to the participant on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.
EuroQol five dimension (EQ-5D) life quality score.
Participant marks on a visual analogue scale from 0 to 100 how they value their current health status where 0 represents the lowest, and 100 highest, health status and quality of life.
Hospital Anxiety Depression (HAD) Score.
Self-assessment with 14 items that assess anxiety and depression symptoms before and after the intervention on a scale from 0 to 21, with higher scores indication the presence of symptoms.
Systolic blood pressure
Change in systolic blood pressure in mm/Hg
Diastolic blood pressure
Change in diastolic blood pressure in mm/Hg
Heart rate
Change in bpm (beats per minute)
Body weight
Change in body weight (kg)
BMI
Change in body weight index (kg/m^2)
Body fat composition
Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale.
Waist-to-hip ratio
Waist circumference/hip circumference
Fasting glucose (mM)
Fasting insulin
HOMA-IR
Homeostasis model assessment of insulin resistance (HOMA-IR)
Lipid metabolism: total cholesterol mg/dl
Lipid metabolism: LDL-cholesterol mg/dl
Lipid metabolism: HDL-cholesterol mg/dl
Lipid metabolism: triglycerides mg/dl
Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio
Lipid metabolism: oxLDL
Oxidized LDL-cholesterol
Liver function: alanine aminotransferase (ALAT) (ukat/L)
Inflammation: hsCRP (mg/L)
high sensitive c-reactive protein
Inflammation: plasma serum amyloid A (mg/L)
Inflammation: IL-6 ng/L
Inflammation: TNFalfa ng/L
Inflammation: IL-12 ng/L
Inflammation: IL-15 ng/L
Inflammation: MCP-1 ng/L
Inflammation: sVCAM-1 (ukat/L)
Inflammation: IFN-g
Biomarker related to cognitive function: BDNF
Change in plasma brain-derived neurotrophic factor (BDNF)
PAL scores (PALTEA)
Change in PALTEA score at different levels of the test
VRM scores
Change in VRM scores at different levels of the test
Full Information
NCT ID
NCT04317612
First Posted
March 4, 2020
Last Updated
January 26, 2023
Sponsor
Region Skane
Collaborators
Lund University, Berry Lab
1. Study Identification
Unique Protocol Identification Number
NCT04317612
Brief Title
Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment
Acronym
MINDBERRY
Official Title
A Randomized, Double-blind, Placebo-controlled Intervention Study to Evaluate the Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome in Adults With Mild Cognitive Impairment The MINDBERRY Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane
Collaborators
Lund University, Berry Lab
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the current study is to investigate whether daily intake of Nordic berries for 12 weeks can improve cognitive abilities of adults with mild cognitive impairment, 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 12 weeks 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 50 volunteers, are studied. Volunteers will be patients attending the Cognitive medicine unit at Ängelholm hospital, who have mild cognitive impairment (but not dementia). 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
Cognitive Impairment, Mild, Memory Impairment
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
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 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 product
Other Intervention Name(s)
inactive control
Intervention Description
Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period.
Primary Outcome Measure Information:
Title
CANTAB - Paired Associate Learning test (PAL28)
Description
To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall)
Time Frame
12 weeks
Title
Attention, psychomotor speed and executive function (Trail making test (TMT) A and B)
Time Frame
12 weeks
Title
Selective attention and processing speed (Stroop color-word test)
Time Frame
12 weeks
Title
Verbal fluency (letter "S" word fluency test)
Description
Number of novel words on letter "S" during 60 seconds.
Time Frame
12 weeks
Title
Behavior and quality of life (AES, Apathy evaluation score (self))
Description
Answers given by the participants on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.
Time Frame
12 weeks
Title
Behavior and quality of life (Apathy evaluation score (informant))
Description
Answers given by someone close to the participant on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.
Time Frame
12 weeks
Title
EuroQol five dimension (EQ-5D) life quality score.
Description
Participant marks on a visual analogue scale from 0 to 100 how they value their current health status where 0 represents the lowest, and 100 highest, health status and quality of life.
Time Frame
12 weeks
Title
Hospital Anxiety Depression (HAD) Score.
Description
Self-assessment with 14 items that assess anxiety and depression symptoms before and after the intervention on a scale from 0 to 21, with higher scores indication the presence of symptoms.
Time Frame
12 weeks
Title
Systolic blood pressure
Description
Change in systolic blood pressure in mm/Hg
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
Change in diastolic blood pressure in mm/Hg
Time Frame
12 weeks
Title
Heart rate
Description
Change in bpm (beats per minute)
Time Frame
12 weeks
Title
Body weight
Description
Change in body weight (kg)
Time Frame
12 weeks
Title
BMI
Description
Change in body weight index (kg/m^2)
Time Frame
12 weeks
Title
Body fat composition
Description
Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale.
Time Frame
12 weeks
Title
Waist-to-hip ratio
Description
Waist circumference/hip circumference
Time Frame
12 weeks
Title
Fasting glucose (mM)
Time Frame
12 weeks
Title
Fasting insulin
Time Frame
12 weeks
Title
HOMA-IR
Description
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time Frame
12 weeks
Title
Lipid metabolism: total cholesterol mg/dl
Time Frame
12 weeks
Title
Lipid metabolism: LDL-cholesterol mg/dl
Time Frame
12 weeks
Title
Lipid metabolism: HDL-cholesterol mg/dl
Time Frame
12 weeks
Title
Lipid metabolism: triglycerides mg/dl
Time Frame
12 weeks
Title
Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio
Time Frame
12 weeks
Title
Lipid metabolism: oxLDL
Description
Oxidized LDL-cholesterol
Time Frame
12 weeks
Title
Liver function: alanine aminotransferase (ALAT) (ukat/L)
Time Frame
12 weeks
Title
Inflammation: hsCRP (mg/L)
Description
high sensitive c-reactive protein
Time Frame
12 weeks
Title
Inflammation: plasma serum amyloid A (mg/L)
Time Frame
12 weeks
Title
Inflammation: IL-6 ng/L
Time Frame
12 weeks
Title
Inflammation: TNFalfa ng/L
Time Frame
12 weeks
Title
Inflammation: IL-12 ng/L
Time Frame
12 weeks
Title
Inflammation: IL-15 ng/L
Time Frame
12 weeks
Title
Inflammation: MCP-1 ng/L
Time Frame
12 weeks
Title
Inflammation: sVCAM-1 (ukat/L)
Time Frame
12 weeks
Title
Inflammation: IFN-g
Time Frame
12 weeks
Title
Biomarker related to cognitive function: BDNF
Description
Change in plasma brain-derived neurotrophic factor (BDNF)
Time Frame
12 weeks
Title
PAL scores (PALTEA)
Description
Change in PALTEA score at different levels of the test
Time Frame
12 weeks
Title
VRM scores
Description
Change in VRM scores at different levels of the test
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Gut microbiota composition
Description
Change in 16s microbial composition in feces samples
Time Frame
12 weeks
Title
Gut function
Description
Questionnaire describing gut function and habits to be filled out before and after the intervention.
Time Frame
12 weeks
Title
Exploratory: correlations between primary variables (cognitive function) and secondary outcome measures and gut microbiota composition.
Time Frame
12 weeks
Title
Exploratory: analyses of interactions between effects on cognitive function and the participant characteristics; dietary habits, drugs, dementia risk-allele, education level and gender.
Time Frame
12 weeks
Title
Adverse events
Description
safety outcomes
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 55 years or older.
Cognitive impairment in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and global deterioration scale (GDS) stage 3.
Capable and willing to give written informed consent.
Capable and willing to perform cognitive testing (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.
Exclusion Criteria:
MMSE (Mini-Mental State Examination) <24 (at screening or in the last 3 months).
Cognitive disease (e.g. dementia) according to Global Deterioration Scale (GDS) stage 4 and up.
Severe affective disorder with current symptoms
Severe mental disorder.
Newly diagnosed or poorly regulated thyroid disease (unstable dose since 3 months back).
Ongoing insulin therapy.
Ongoing treatment for malignancy*.
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).
Planned major intervention in health care over the next 3 months (the study period).
Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.
Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).
Vegetarians / vegans.
Smoking.
Abuse of alcohol or psychoactive substance.
Significant change in medication over the last 3 months.
Daily, regular high consumption of berries or juices / marmalade / product with high content of these berries (guideline no more than 5 grams per day). (Can be recruited for the study if this intake ceases before visit 1. High consumes (approximately 1 dl of berries per day) has to cease with this at least one month before visit 1.)
Taking supplements with potential cognitive effects (e.g. omega-3, ginko biloba), or containing grape and berry extracts or probiotics (capsules or other). (Can be recruited if this intake ceases at least one month before visit 1).
Planned longer absence/vacation during the next 3 months (the study period).
Concurrent participation in other clinical intervention trials (dietary/pharmacological).
Other reasons that make the Study investigator in consultation with the responsible physician deem the person inappropriate to include.
basalioma exempt from exclusion criteria.
Facility Information:
Facility Name
Cognitve medicine
City
Ängelholm
ZIP/Postal Code
26253
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Landqvist Waldö, MD PhD
Phone
0046725950639
Email
maria.landqvist_waldo@med.lu.se
Facility Name
Cognitive medicine
City
Ängelholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Landqvist Waldö, MD PhD
Phone
0725950639
Email
maria.landqvist_waldo@med.lu.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment
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