Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function

NCT05693441 | Completed

• 1 other identifier: SCANBerry2022
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to investigate whether acute and 12-weeks daily intake of Nordic berries can improve cognitive abilities of adults without cognitive disease, and whether the effect can be linked to changes in metabolic parameters.

Conditions

Age-related Cognitive Decline

Keywords

cognitive function; memory

Outcome Measures

Primary Outcomes (10)

• Cognitive measures-memory

  Episodic memory - assessed using computerized cognitive battery including PAL (paired associates learning) test.

  Change from baseline following 12 weeks daily consumption, compared to control

• Cognitive measures-memory

  Episodic memory - assessed using computerized cognitive battery including VRM (verbal recognition memory) test

  Change from baseline following 12 weeks daily consumption, compared to control

• Cognitive measures - memory

  Working memory - assessed using computerized cognitive battery including SWM (spatial working memory) test.

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - memory

  Working memory - assessed using computerized cognitive battery including SDPT (symbol digits processing test).

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - executive function

  Executive function - assessed using computerized cognitive battery including TMT (trail making test) A \& B.

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - executive function

  Executive function - assessed using computerized cognitive battery including PASAT (paced auditory serial addition test).

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - executive function

  Executive function - assessed using computerized cognitive battery including Stroop test.

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - executive function

  Executive function, verbal fluency - assessed using computerized cognitive battery including F-A-S test measuring word fluency

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures - attention

  Attention, reaction time - assessed using computerized cognitive battery including RTI (reaction time) test.

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Cognitive measures

  Global cognitive function - assessed by calculating a z-score from the cognitive battery score outcomes

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

Secondary Outcomes (25)

• Circulating plasma biomarkers relating to cognitive function

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Mood measurement

  Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control

• Self-reported quality of life

  Difference from baseline vs control following 12 weeks of daily consumption

• Well-being measurement

  Difference from baseline vs control following 12 weeks of daily consumption

• Subjective memory

  Difference from baseline vs control following 12 weeks of daily consumption

Other Outcomes (10)

• Gut microbiota composition

  Difference from baseline vs control following 12 weeks of daily consumption

• Gut function

  Difference from baseline vs control following 12 weeks of daily consumption

• Untargeted plasma metabolome

  Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption

Study Arms (2)

Active berry product

ACTIVE COMPARATOR

Once daily consumption over the period of the study

Other: Active berry product

Reference berry-like product

PLACEBO COMPARATOR

Once daily consumption over the period of the study

Other: Reference berry-like 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 berry-like product OTHER

Subjects should consume a reference product (isocaloric to active product, containing berry aromas and colouring but no actual berry compounds) daily during the 12 week intervention period.

Also known as: Inactive control

Reference berry-like product

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60-85 years.
• Capable and willing to give written informed consent.
• Capable and willing to perform cognitive testing in Swedish (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.
• Agree to maintain consistent dietary habits and physical activity levels for the duration of the study

You may not qualify if:

• Known to be affected by major neurocognitive disorder/dementia or low score on cognitive screening test (Mini Mental State Examination (MMSE) score less than 24.
• Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.
• Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.
• Underweight (BMI \<18.5).
• Significant psychiatric disorders with current symptoms.
• Type 1 diabetes, recently diagnosis of Type 2 diabetes (\<12 months) or ongoing insulin treatment.
• Ongoing treatment for malignancy\*.
• Significant change in medication over the last 3 months.
• Blood donation before (3 months) or during the study period.
• Planned major intervention in health care or change in medication over the next 3 months (study period).
• Currently active smoker or regular use of other nicotine products.
• Drug or alcohol abuse.
• 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).
• Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).
• Vegetarians / vegans.

Sponsors & Collaborators

• Aventure AB: lead
• Berry Lab AB: collaborator

Study Sites (1)

Aventure AB

Lund, Sweden

Location

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: January 23, 2023
• Study Start: January 17, 2023
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)