NCT05693441

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Aventure AB · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	Active berry product	Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
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.

Timeline

• Start date: 2023-01-17
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2023-01-23
• Last updated: 2023-07-06

Locations

1 site across 1 country: Sweden