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

NCT04317612 | Completed

• 1 other identifier: Mindberry2020
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Cognitive Impairment, Mild; Memory Impairment

Outcome Measures

Primary Outcomes (1)

• CANTAB - Paired Associate Learning test (PAL28)

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

  12 weeks

Secondary Outcomes (37)

• 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

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

  12 weeks

• Verbal fluency (letter "S" word fluency test)

  12 weeks

• Behavior and quality of life (AES, Apathy evaluation score (self))

  12 weeks

Other Outcomes (5)

• Gut microbiota composition

  12 weeks

• Gut function

  12 weeks

• Exploratory: correlations between primary variables (cognitive function) and secondary outcome measures and gut microbiota composition.

  12 weeks

Study Arms (2)

Active berry product

ACTIVE COMPARATOR

Once daily consumption over the period of the study

Other: Active berry product

Reference product

PLACEBO COMPARATOR

Once daily consumption over the period of the study

Other: Reference product

Interventions

Active berry product OTHER

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

Active berry product

Reference product OTHER

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

Also known as: inactive control

Reference product

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.)

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator
• Berry Lab: collaborator

Study Sites (2)

Cognitve medicine

Ängelholm, 26253, Sweden

Location

Cognitive medicine

Ängelholm, Sweden

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 23, 2020
• Study Start: June 3, 2020
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)