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| Name | Class |
|---|---|
| Lund University | OTHER |
| Berry Lab | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active berry product | Active Comparator | Once daily consumption over the period of the study |
|
| Reference product | Placebo Comparator | Once daily consumption over the period of the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active berry product | Other | Subjects should consume the active product containing nordic berries daily during the 12 week intervention period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CANTAB - Paired Associate Learning test (PAL28) | To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall) | 12 weeks | |
| Attention, psychomotor speed and executive function (Trail making test (TMT) A and B) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota composition | Change in 16s microbial composition in feces samples | 12 weeks |
| Gut function | Questionnaire describing gut function and habits to be filled out before and after the intervention. |
Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cognitve medicine | Ängelholm | 26253 | Sweden | |||
| Cognitive medicine |
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Parallel assignment
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| Reference product | Other | Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period. |
|
|
| Selective attention and processing speed (Stroop color-word test) | 12 weeks |
| Verbal fluency (letter "S" word fluency test) | Number of novel words on letter "S" during 60 seconds. | 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. | 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. | 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. | 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. | 12 weeks |
| Systolic blood pressure | Change in systolic blood pressure in mm/Hg | 12 weeks |
| Diastolic blood pressure | Change in diastolic blood pressure in mm/Hg | 12 weeks |
| Heart rate | Change in bpm (beats per minute) | 12 weeks |
| Body weight | Change in body weight (kg) | 12 weeks |
| BMI | Change in body weight index (kg/m^2) | 12 weeks |
| Body fat composition | Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale. | 12 weeks |
| Waist-to-hip ratio | Waist circumference/hip circumference | 12 weeks |
| Fasting glucose (mM) | 12 weeks |
| Fasting insulin | 12 weeks |
| HOMA-IR | Homeostasis model assessment of insulin resistance (HOMA-IR) | 12 weeks |
| Lipid metabolism: total cholesterol mg/dl | 12 weeks |
| Lipid metabolism: LDL-cholesterol mg/dl | 12 weeks |
| Lipid metabolism: HDL-cholesterol mg/dl | 12 weeks |
| Lipid metabolism: triglycerides mg/dl | 12 weeks |
| Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio | 12 weeks |
| Lipid metabolism: oxLDL | Oxidized LDL-cholesterol | 12 weeks |
| Liver function: alanine aminotransferase (ALAT) (ukat/L) | 12 weeks |
| Inflammation: hsCRP (mg/L) | high sensitive c-reactive protein | 12 weeks |
| Inflammation: plasma serum amyloid A (mg/L) | 12 weeks |
| Inflammation: IL-6 ng/L | 12 weeks |
| Inflammation: TNFalfa ng/L | 12 weeks |
| Inflammation: IL-12 ng/L | 12 weeks |
| Inflammation: IL-15 ng/L | 12 weeks |
| Inflammation: MCP-1 ng/L | 12 weeks |
| Inflammation: sVCAM-1 (ukat/L) | 12 weeks |
| Inflammation: IFN-g | 12 weeks |
| Biomarker related to cognitive function: BDNF | Change in plasma brain-derived neurotrophic factor (BDNF) | 12 weeks |
| PAL scores (PALTEA) | Change in PALTEA score at different levels of the test | 12 weeks |
| VRM scores | Change in VRM scores at different levels of the test | 12 weeks |
| 12 weeks |
| Exploratory: correlations between primary variables (cognitive function) and secondary outcome measures and gut microbiota composition. | 12 weeks |
| Exploratory: analyses of interactions between effects on cognitive function and the participant characteristics; dietary habits, drugs, dementia risk-allele, education level and gender. | 12 weeks |
| Adverse events | safety outcomes | 12 weeks |
| Ängelholm |
| Sweden |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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