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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
96
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period.
Cognitve medicine
Ängelholm, Sweden
Cognitive medicine
Ängelholm, Sweden
CANTAB - Paired Associate Learning test (PAL28)
To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory
Time frame: 12 weeks
Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall)
Time frame: 12 weeks
Attention, psychomotor speed and executive function (Trail making test (TMT) A and B)
Time frame: 12 weeks
Selective attention and processing speed (Stroop color-word test)
Time frame: 12 weeks
Verbal fluency (letter "S" word fluency test)
Number of novel words on letter "S" during 60 seconds.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
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.
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Time frame: 12 weeks
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.
Time frame: 12 weeks
Systolic blood pressure
Change in systolic blood pressure in mm/Hg
Time frame: 12 weeks
Diastolic blood pressure
Change in diastolic blood pressure in mm/Hg
Time frame: 12 weeks
Heart rate
Change in bpm (beats per minute)
Time frame: 12 weeks
Body weight
Change in body weight (kg)
Time frame: 12 weeks
BMI
Change in body weight index (kg/m\^2)
Time frame: 12 weeks
Body fat composition
Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale.
Time frame: 12 weeks
Waist-to-hip ratio
Waist circumference/hip circumference
Time frame: 12 weeks
Fasting glucose (mM)
Time frame: 12 weeks
Fasting insulin
Time frame: 12 weeks
HOMA-IR
Homeostasis model assessment of insulin resistance (HOMA-IR)
Time frame: 12 weeks
Lipid metabolism: total cholesterol mg/dl
Time frame: 12 weeks
Lipid metabolism: LDL-cholesterol mg/dl
Time frame: 12 weeks
Lipid metabolism: HDL-cholesterol mg/dl
Time frame: 12 weeks
Lipid metabolism: triglycerides mg/dl
Time frame: 12 weeks
Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio
Time frame: 12 weeks
Lipid metabolism: oxLDL
Oxidized LDL-cholesterol
Time frame: 12 weeks
Liver function: alanine aminotransferase (ALAT) (ukat/L)
Time frame: 12 weeks
Inflammation: hsCRP (mg/L)
high sensitive c-reactive protein
Time frame: 12 weeks
Inflammation: plasma serum amyloid A (mg/L)
Time frame: 12 weeks
Inflammation: IL-6 ng/L
Time frame: 12 weeks
Inflammation: TNFalfa ng/L
Time frame: 12 weeks
Inflammation: IL-12 ng/L
Time frame: 12 weeks
Inflammation: IL-15 ng/L
Time frame: 12 weeks
Inflammation: MCP-1 ng/L
Time frame: 12 weeks
Inflammation: sVCAM-1 (ukat/L)
Time frame: 12 weeks
Inflammation: IFN-g
Time frame: 12 weeks
Biomarker related to cognitive function: BDNF
Change in plasma brain-derived neurotrophic factor (BDNF)
Time frame: 12 weeks
PAL scores (PALTEA)
Change in PALTEA score at different levels of the test
Time frame: 12 weeks
VRM scores
Change in VRM scores at different levels of the test
Time frame: 12 weeks