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Cognitive Impairment, MildMINDBERRYNCT04317612

Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiota in Adults With Mild Cognitive Impairment

A study testing Active berry product and Reference product in people with Cognitive Impairment, Mild and Memory Impairment, run by Region Skane at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Cognitive Impairment, Mild, Memory Impairment
What is being tested?
Active berry product and Reference product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
2 sitesSweden
Study dates
3 Jun 2020to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Cognitve medicine

    Ängelholm, 26253

  • Cognitive medicine

    Ängelholm

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Active berry product, Reference product
Medical subject headings
Cognitive Dysfunction, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active berry productOther

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

  • Reference productOther

    Also called inactive control

    Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period.

Study groups in NCT04317612
Study groupRoleWhat they receive
Active berry productActive comparatorOnce daily consumption over the period of the study
Receives: Other: Active berry product
Reference productPlacebo comparatorOnce daily consumption over the period of the study
Receives: Other: Reference product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CANTAB - Paired Associate Learning test (PAL28)

    To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory

    Measured: 12 weeks

Secondary outcomes (37)

  1. Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall)

    Measured: 12 weeks

  2. Attention, psychomotor speed and executive function (Trail making test (TMT) A and B)

    Measured: 12 weeks

  3. Selective attention and processing speed (Stroop color-word test)

    Measured: 12 weeks

  4. Verbal fluency (letter "S" word fluency test)

    Number of novel words on letter "S" during 60 seconds.

    Measured: 12 weeks

  5. 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.

    Measured: 12 weeks

  6. 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.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. 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.

    Measured: 12 weeks

  9. Systolic blood pressure

    Change in systolic blood pressure in mm/Hg

    Measured: 12 weeks

  10. Diastolic blood pressure

    Change in diastolic blood pressure in mm/Hg

    Measured: 12 weeks

  11. Heart rate

    Change in bpm (beats per minute)

    Measured: 12 weeks

  12. Body weight

    Change in body weight (kg)

    Measured: 12 weeks

  13. BMI

    Change in body weight index (kg/m^2)

    Measured: 12 weeks

  14. Body fat composition

    Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale.

    Measured: 12 weeks

  15. Waist-to-hip ratio

    Waist circumference/hip circumference

    Measured: 12 weeks

  16. Fasting glucose (mM)

    Measured: 12 weeks

  17. Fasting insulin

    Measured: 12 weeks

  18. HOMA-IR

    Homeostasis model assessment of insulin resistance (HOMA-IR)

    Measured: 12 weeks

  19. Lipid metabolism: total cholesterol mg/dl

    Measured: 12 weeks

  20. Lipid metabolism: LDL-cholesterol mg/dl

    Measured: 12 weeks

  21. Lipid metabolism: HDL-cholesterol mg/dl

    Measured: 12 weeks

  22. Lipid metabolism: triglycerides mg/dl

    Measured: 12 weeks

  23. Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio

    Measured: 12 weeks

  24. Lipid metabolism: oxLDL

    Oxidized LDL-cholesterol

    Measured: 12 weeks

  25. Liver function: alanine aminotransferase (ALAT) (ukat/L)

    Measured: 12 weeks

  26. Inflammation: hsCRP (mg/L)

    high sensitive c-reactive protein

    Measured: 12 weeks

  27. Inflammation: plasma serum amyloid A (mg/L)

    Measured: 12 weeks

  28. Inflammation: IL-6 ng/L

    Measured: 12 weeks

  29. Inflammation: TNFalfa ng/L

    Measured: 12 weeks

  30. Inflammation: IL-12 ng/L

    Measured: 12 weeks

  31. Inflammation: IL-15 ng/L

    Measured: 12 weeks

  32. Inflammation: MCP-1 ng/L

    Measured: 12 weeks

  33. Inflammation: sVCAM-1 (ukat/L)

    Measured: 12 weeks

  34. Inflammation: IFN-g

    Measured: 12 weeks

  35. Biomarker related to cognitive function: BDNF

    Change in plasma brain-derived neurotrophic factor (BDNF)

    Measured: 12 weeks

  36. PAL scores (PALTEA)

    Change in PALTEA score at different levels of the test

    Measured: 12 weeks

  37. VRM scores

    Change in VRM scores at different levels of the test

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start3 Jun 2020
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317612
Sponsor's protocol ID
Mindberry2020
Acronym
MINDBERRY
Status last verified
Feb 2024
First submitted
4 Mar 2020
Last updated
1 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active berry product and Reference product in people with Cognitive Impairment, Mild and Memory Impairment, run by Region Skane at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CANTAB - Paired Associate Learning test (PAL28) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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