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

Age-related Cognitive Decline Clinical Trial

— SCANBerry  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05693441
• Other study ID #: SCANBerry2022
• Status: Completed
• Phase: N/A
• Start date: January 17, 2023
• Est. completion date: June 22, 2023

Study information

• Verified date: July 2023
• Source: Aventure AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 22, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• Active berry product
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
• 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.

Locations

Country	Name	City	State
Sweden	Aventure AB	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Aventure AB	Berry Lab AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota composition	Sequencing of fecal samples	Difference from baseline vs control following 12 weeks of daily consumption
Other	Gut function	Questionnaire on gut function. The subject is asked to grade the frequency of symtomps of bloating, flatulence, abdominal pain and cramping, constipation and defecation pain, on a scale from 0 (never) to 3 (frequently).	Difference from baseline vs control following 12 weeks of daily consumption
Other	Untargeted plasma metabolome	Untargeted plasma metabolomics will be employed to exploratively assess alterations in metabolites and to identify metabolites that increase or change with berry consumption	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with gender	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with age	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with sex	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with dietary habits	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with education level	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Explorative subgroup analyses (interactions)	Data analyses of how effects on the primary outcome (cognition) interacts with intake of permitted medications	Difference from baseline vs control 1.5h post dose and following 12 weeks of daily consumption
Other	Adverse events	Unexpected health problems and safety outcomes.	Through study completion (12 weeks)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Circulating plasma biomarkers relating to cognitive function	Brain derived neurotrophic factor (BDNF)	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Mood measurement	assessed using SCAS (the Swedish Core Affect Scale) mood questionnaire. A validated self-report measure of affective state. The SCAS comprises of 12 affective states that subjects rate on a scale from 1 - 10.	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Self-reported quality of life	assessed using the quality of life scale from the EQ-5D (EuroQol 5 Dimension) self-report survey. The subject grades their current overall quality of life on a scale 0-100.	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Well-being measurement	Assessed with World Health Organization- Five Well-Being Index (WHO-5). A validated 5 item scale for self-reporting levels of perceived well-being over the last two weeks. Items are rated using a 5-point scale.	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Subjective memory	Assessed using 3 simple questions about the subject's own memory evaluation. The subject is asked to rate their memory function (scale 0 to 7), how they percieve their own memory is working compared to others in the same age (0 to 5) and if anyone close to them has expressed concern over the subjects' memory	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Cardiometabolic risk factor	blood pressure (SBP)	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Cardiometabolic risk factor	blood pressure (DBP)	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Cardiometabolic risk factor	Heart rate (HR)	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Body composition	Body weight (kg)	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Body composition	Body mass index (BMI) (e.g., weight (kg) and height (m) will be combined to report BMI in kg/m^2).	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Body composition	body fat % (measured by bioelectrical impedance analysis)	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Body composition	Waist circumference (cm)	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Biomarkers of glycemia	glucose levels in blood	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Biomarkers of glycemia	insulin levels in blood	Change from baseline at 1.5 hours post-dose, and 12 weeks daily consumption, compared to control
Secondary	Biomarkers of glycemia	HOMA-IR (insulin resistance index, calculated based on fasting glucose and insulin levels)	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Biomarkers of glycemia	Fructosamine levels in blood	Change from baseline following 12 weeks daily consumption, compared to control
Secondary	Biomarkers of lipemia in blood plasma	triacylglycerols	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of lipemia in blood plasma	total cholesterol	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of lipemia in blood plasma	HDL-cholesterol	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of lipemia in blood plasma	LDL-cholesterol	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of lipemia in blood plasma	ApoB/A1	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarker endothelial function in blood plasma	sVCAM-1	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of liver function in blood plasma	ALAT	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of inflammation and oxidative stress blood plasma	Interleukin	Difference from baseline vs control following 12 weeks of daily consumption
Secondary	Biomarkers of inflammation and oxidative stress blood plasma	acute phase proteins (C-reactive protein)	Difference from baseline vs control following 12 weeks of daily consumption