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

NCT ID: NCT05693441

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2023-06-22

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.

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 acute and 12 weeks daily 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 30 volunteers, are studied. 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.

Conditions

Age-related Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active berry product

Once daily consumption over the period of the study

Group Type: ACTIVE_COMPARATOR

Active berry product

Intervention Type: OTHER

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

Reference berry-like product

Once daily consumption over the period of the study

Group Type: PLACEBO_COMPARATOR

Reference berry-like product

Intervention Type: 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.

Interventions

Active berry product

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

Intervention Type: OTHER

Reference berry-like product

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.

Intervention Type: OTHER

Other Intervention Names

Inactive control

Eligibility Criteria

Inclusion Criteria

1. Age 60-85 years.

2. Capable and willing to give written informed consent.

3. 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).

4. Capable and willing to ingest the study beverage for 12 weeks and to follow the instructions given.

5. Agree to maintain consistent dietary habits and physical activity levels for the duration of the study

Exclusion Criteria

1. 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.

2. Affected by other medical condition(s) or medication(s) known to significantly affect cognitive function.

3. Past history of brain damage, significant head trauma (including loss of consciousness as a result), brain surgery or stroke.

4. Underweight (BMI <18.5).

5. Significant psychiatric disorders with current symptoms.

6. Type 1 diabetes, recently diagnosis of Type 2 diabetes (<12 months) or ongoing insulin treatment.

7. Ongoing treatment for malignancy*.

8. Significant change in medication over the last 3 months.

9. Undergoing antibiotic therapy for the last 3 months prior to inclusion in the study.

10. Blood donation before (3 months) or during the study period.

11. Planned major intervention in health care or change in medication over the next 3 months (study period).

12. Currently active smoker or regular use of other nicotine products.

13. Drug or alcohol abuse.

14. 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).

15. Allergy / intolerance to berries or other ingredients in the study products (i.e., colorants, aromas, starch).

16. Vegetarians / vegans.

17. Daily, regular high consumption (approximately 1 dl or more per day) of berries or juices / marmalade / products with high content of bilberries and lingonberries. (Can be recruited if consumption has ceased to less than 5 grams of berries per day at least 1 month before visit 1.).

18. Taking supplements with potential cognitive effects (e.g., omega-3, ginko biloba, Souvenaid), or containing grape and berry extracts or probiotics (capsules or ProViva). (Can be recruited if this intake ceases at least one month before visit 1).

19. Planned longer absence/vacation during the next 3 months (study period).

20. Sharing household with someone participating in the current study

21. Concurrent participation in other clinical intervention trials (dietary/pharmacological).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Berry Lab AB

UNKNOWN

Sponsor Role: collaborator

Aventure AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aventure AB

Lund, , Sweden

Countries

Sweden

Other Identifiers

SCANBerry2022

Identifier Type: -

Identifier Source: org_study_id