Effects of Anthocyanin Supplementation on Serum Lipids, Glucose, Markers of Inflammation and Cognition in Adults With Increased Risk of Dementia – A Pilot Study

Abstract

Background: Anthocyanins may protect against cardiovascular related cognitive decline and dementia. Objective: Open-label study to measure changes in serum lipids, glucose, glycosylated hemoglobin (HbA1c), and markers of inflammation after anthocyanin supplementation in people with increased risk of dementia. As a secondary endpoint we examined potential changes in a battery of cognitive test in the anthocyanin group (AG). A total of 27 individuals with mild cognitive impairment (MCI) (n = 8) or stable non-obstructive coronary artery disease (CAD) (n = 19) consumed two Medox R capsules, each containing 80 mg of natural purified anthocyanins, twice daily for 16 weeks. They provided blood samples and performed a short battery of cognitive tests. Twenty healthy normal controls (NC) (n = 20) provided blood samples, but did not receive any intervention and did not perform cognitive tests. Results: There was a significant difference between groups for CCL-5/RANTES [regulated on activation, normal T-cell expressed and secreted (RANTES)]. In addition, total cholesterol and triglycerides were significantly increased in the AG. Improvements in memory and executive test scores were observed. No adverse effects were reported. Conclusion: The results of this pilot study were largely inconclusive with regard to the potential protective effects of anthocyanin supplementation. However,

Effects of Purified Anthocyanins in People at Risk for Dementia: Study Protocol for a Phase II Randomized Controlled Trial

“…Each capsule contains 80-mg anthocyanins, and the dosage chosen is four capsules, 320 mg/day, whereas the identically appearing placebo capsules contain 91% maltodextrin and 9% citric acid. This dosage has been reported to be associated with relevant biological alterations ( 19 , 21 , 30 , 36 ) and to have good tolerability ( 30 ). The manufacturer of Medox®, MedPalett, is producing Medox® and identically appearing placebo capsules.…”

“…Anthocyanins are safe ( 30 ), and there are no serious adverse effects to be expected. The study will nevertheless focus on safety, as explained later.…”

“…Given the safety profile of anthocyanins that have been reported ( 30 , 43 ), we expect the need for emergency unblinding to be extremely rare. Nevertheless, we have the following procedure in case emergency unblinding is required:…”

“…The valuable feedback provided by our participants in our pilot study ( 30 ) was taken into consideration in developing the anthocyanins in people at risk for dementia study design. The user involvement representatives at the center for age-related medicine at SUS have contributed by giving their inputs and recommendations to develop the advertising flyers and have also helped to promote the publicity of the study and recruitment.…”

“…Also, we measure the effects on microcirculation and endothelial elasticity. Our recent pilot study showed that the anthocyanin capsules were well-tolerated ( 30 ).…”