Clinical trial NCT05693441: Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function
Official title: Study on the Chronic and Acute Effects of Nordic Berry Beverage on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome: A Randomized, Double-blind, Placebo-controlled Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Cognitive Decline
Keywords: cognitive function
memory
Lead sponsor: Aventure AB
Sponsor class: INDUSTRY
Collaborators: name: Berry Lab AB
First posted: 2023-01-23
Enrollment: 62
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).
22. Other reasons that make the SD in consultation with the PI deem the person inappropriate to include. \*basalioma exempt from exclusion criteria

Primary outcomes:
measure: Cognitive measures-memory
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Cognitive measures-memory
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Cognitive measures - memory
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - memory
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - executive function
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - executive function
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - executive function
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - executive function
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures - attention
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cognitive measures
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary outcomes:
measure: Circulating plasma biomarkers relating to cognitive function
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Mood measurement
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Self-reported quality of life
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Well-being measurement
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Subjective memory
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Cardiometabolic risk factor
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cardiometabolic risk factor
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Cardiometabolic risk factor
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Body composition
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Body composition
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Body composition
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Body composition
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Biomarkers of glycemia
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Biomarkers of glycemia
timeFrame: Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
measure: Biomarkers of glycemia
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Biomarkers of glycemia
timeFrame: Change from baseline following 12 weeks daily consumption, compared to control
measure: Biomarkers of lipemia in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of lipemia in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of lipemia in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of lipemia in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of lipemia in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarker endothelial function in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of liver function in blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of inflammation and oxidative stress blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Biomarkers of inflammation and oxidative stress blood plasma
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
Other outcomes:
measure: Gut microbiota composition
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Gut function
timeFrame: Difference from baseline vs control following 12 weeks of daily consumption
measure: Untargeted plasma metabolome
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Explorative subgroup analyses (interactions)
timeFrame: Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
measure: Adverse events
timeFrame: Through study completion (12 weeks)
Locations:
city: Lund
country: Sweden
facility: Aventure AB
Study officials:
References: