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

Memory Impairment Clinical Trial

— MINDBERRY  

Official title:

A Randomized, Double-blind, Placebo-controlled Intervention Study to Evaluate the Effect of Nordic Berries on Cognitive Function, Cardiometabolic Risk Markers and Gut Microbiome in Adults With Mild Cognitive Impairment The MINDBERRY Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317612
• Other study ID #: Mindberry2020
• Status: Completed
• Phase: N/A
• Start date: June 3, 2020
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 12 weeks 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 50 volunteers, are studied. Volunteers will be patients attending the Cognitive medicine unit at Ängelholm hospital, who have mild cognitive impairment (but not dementia). 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: 96
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Age of 55 years or older.

2. Cognitive impairment in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria and global deterioration scale (GDS) stage 3.

3. Capable and willing to give written informed consent.

4. 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).

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

Exclusion Criteria:

1. MMSE (Mini-Mental State Examination) <24 (at screening or in the last 3 months).

2. Cognitive disease (e.g. dementia) according to Global Deterioration Scale (GDS) stage 4 and up.

3. Severe affective disorder with current symptoms

4. Severe mental disorder.

5. Newly diagnosed or poorly regulated thyroid disease (unstable dose since 3 months back).

6. Ongoing insulin therapy.

7. Ongoing treatment for malignancy*.

8. 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).

9. Planned major intervention in health care over the next 3 months (the study period).

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

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

12. Vegetarians / vegans.

13. Smoking.

14. Abuse of alcohol or psychoactive substance.

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

16. 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.)

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

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

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

20. Other reasons that make the Study investigator in consultation with the responsible physician deem the person inappropriate to include.

• basalioma exempt from exclusion criteria.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Memory Impairment

Intervention

Other:
• Active berry product
Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
• Reference product
Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period.

Locations

Country	Name	City	State
Sweden	Cognitive medicine	Ängelholm
Sweden	Cognitve medicine	Ängelholm

Sponsors (3)

Lead Sponsor	Collaborator
Region Skane	Berry Lab, Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota composition	Change in 16s microbial composition in feces samples	12 weeks
Other	Gut function	Questionnaire describing gut function and habits to be filled out before and after the intervention.	12 weeks
Other	Exploratory: correlations between primary variables (cognitive function) and secondary outcome measures and gut microbiota composition.		12 weeks
Other	Exploratory: analyses of interactions between effects on cognitive function and the participant characteristics; dietary habits, drugs, dementia risk-allele, education level and gender.		12 weeks
Other	Adverse events	safety outcomes	12 weeks
Primary	CANTAB - Paired Associate Learning test (PAL28)	To investigate how daily berry intake affects cognitive function (primary objective) measured by episodic memory	12 weeks
Secondary	Episodic memory (test verbal recognition memory (VRM) (free-, immediate- and delayed recall)		12 weeks
Secondary	Attention, psychomotor speed and executive function (Trail making test (TMT) A and B)		12 weeks
Secondary	Selective attention and processing speed (Stroop color-word test)		12 weeks
Secondary	Verbal fluency (letter "S" word fluency test)	Number of novel words on letter "S" during 60 seconds.	12 weeks
Secondary	Behavior and quality of life (AES, Apathy evaluation score (self))	Answers given by the participants on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.	12 weeks
Secondary	Behavior and quality of life (Apathy evaluation score (informant))	Answers given by someone close to the participant on 18 questions reflect apathy including behavioral, cognitive and emotional indicators on a scale 18-72 where higher scores reflect more apathy.	12 weeks
Secondary	EuroQol five dimension (EQ-5D) life quality score.	Participant marks on a visual analogue scale from 0 to 100 how they value their current health status where 0 represents the lowest, and 100 highest, health status and quality of life.	12 weeks
Secondary	Hospital Anxiety Depression (HAD) Score.	Self-assessment with 14 items that assess anxiety and depression symptoms before and after the intervention on a scale from 0 to 21, with higher scores indication the presence of symptoms.	12 weeks
Secondary	Systolic blood pressure	Change in systolic blood pressure in mm/Hg	12 weeks
Secondary	Diastolic blood pressure	Change in diastolic blood pressure in mm/Hg	12 weeks
Secondary	Heart rate	Change in bpm (beats per minute)	12 weeks
Secondary	Body weight	Change in body weight (kg)	12 weeks
Secondary	BMI	Change in body weight index (kg/m^2)	12 weeks
Secondary	Body fat composition	Body fat composition (% body fat, fat free mass (kg), basal metabolic rate (BMR) measured with TANITA scale.	12 weeks
Secondary	Waist-to-hip ratio	Waist circumference/hip circumference	12 weeks
Secondary	Fasting glucose (mM)		12 weeks
Secondary	Fasting insulin		12 weeks
Secondary	HOMA-IR	Homeostasis model assessment of insulin resistance (HOMA-IR)	12 weeks
Secondary	Lipid metabolism: total cholesterol mg/dl		12 weeks
Secondary	Lipid metabolism: LDL-cholesterol mg/dl		12 weeks
Secondary	Lipid metabolism: HDL-cholesterol mg/dl		12 weeks
Secondary	Lipid metabolism: triglycerides mg/dl		12 weeks
Secondary	Lipid metabolism: apolipoprotein B/ apolipoprotein A1 ratio		12 weeks
Secondary	Lipid metabolism: oxLDL	Oxidized LDL-cholesterol	12 weeks
Secondary	Liver function: alanine aminotransferase (ALAT) (ukat/L)		12 weeks
Secondary	Inflammation: hsCRP (mg/L)	high sensitive c-reactive protein	12 weeks
Secondary	Inflammation: plasma serum amyloid A (mg/L)		12 weeks
Secondary	Inflammation: IL-6 ng/L		12 weeks
Secondary	Inflammation: TNFalfa ng/L		12 weeks
Secondary	Inflammation: IL-12 ng/L		12 weeks
Secondary	Inflammation: IL-15 ng/L		12 weeks
Secondary	Inflammation: MCP-1 ng/L		12 weeks
Secondary	Inflammation: sVCAM-1 (ukat/L)		12 weeks
Secondary	Inflammation: IFN-g		12 weeks
Secondary	Biomarker related to cognitive function: BDNF	Change in plasma brain-derived neurotrophic factor (BDNF)	12 weeks
Secondary	PAL scores (PALTEA)	Change in PALTEA score at different levels of the test	12 weeks
Secondary	VRM scores	Change in VRM scores at different levels of the test	12 weeks