NCT02409446

Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins

Metabolic, Vascular and Cognitive Effects of Treatment With Anthocyanins in Older Adults at Risk for Adverse Outcomes - a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Helse Stavanger HF · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to examine weather treatment with anthocyanins will affect lipid profile, markers of inflammation and oxidative stress in addition to antioxidative level in serum to the better in persons with increased risk of dementia. The purpose of this study is to examine weather treatment with anthocyanins will increase the score of relevant tests of cognitive function. The investigators will do an open pilot study where patients receive anthocyanin for 16 weeks. 34 patients are expected to be included. In addition we will include 20 healthy Controls.

Detailed description

Design, method and material: The investigators will first do an open pilot study where 30 people will receive anthocyanins for 16 weeks. The investigators aim to recruit persons with increased risk of cognitive reduction: persons over 50 years with stable coronary heart disease (CAD) from the cardiology department Stavanger University Hospital. In addition will persons with mild cognitive impairment or mild dementia be included from the memory outpatient clinic, Stavanger University Hospital. Blood will be taken by venepuncture by an experienced nurse, centrifuged and handled in according to standardized procedures. The patients will be tested in relevant tests of cognitive function at inclusion and after 16 weeks. At inclusion the patients will be tested in Mini Mental State Examination (MMSE) and Geriatric depression scale (GDS) to make sure that the patients meet the inclusion criteria. At inclusion and after 16 weeks the patients will be tested in Word List Memory Word List Recall Word List Recognition, Trail Making Test A + B and Stroop Word and Colour test. From the healthy controls blood will be taken at inclusion and study end.

Conditions

• Coronary Disease
• Inflammation
• Cognitive Impairment

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Anthocyanin	Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-11-01
• Completion: 2018-11-01
• First posted: 2015-04-06
• Last updated: 2019-02-18

Locations

1 site across 1 country: Norway