Dag Aarsland, Khadija Khalifa, Anne K. Bergland, Hogne Soennesyn, Ketil Oppedal, Lise B.a. Holteng, Ragnhild Oesterhus, Arne Nakling, Jonas A. Jarholm, Chiara De lucia, Tormod Fladby, Helen Brooker, Ingvild Dalen, Clive Ballard
Funding Information:
DA has received research support and honoraria from Eisai (Evonik), Biogen, NSC Therapeutics, and GE Health. The work in this paper represents independent research partly funded by the National Institute for Health Research Biomedical Research Centre in South London and Maudsley National Health Service Foundation Trust, and King's College London
Funding Information:
DA has received research support and honoraria from Eisai (Evonik), Biogen, NSC Therapeutics , and GE Health . The work in this paper represents independent research partly funded by the National Institute for Health Research Biomedical Research Centre in South London and Maudsley National Health Service Foundation Trust, and King's College London
Publisher Copyright:
© 2022 The Authors
Importance
Identifying nutritional compounds which can reduce cognitive decline in older people is a hugely important topic.
Objective
To study the safety and effect of anthocyanins in maintaining cognitive functioning in people at increased risk for dementia.
Design, setting, and participants
Participants (206 individuals, aged 60–80 years) diagnosed with either mild cognitive impairment (MCI) or two or more cardiometabolic disorders (i.e., diabetes, hypertension, obesity) were enrolled at three different centres in Norway.
Intervention
Participants were randomly assigned to four capsules with a total of 320 mg/d of naturally purified anthocyanins or placebo 1:1 for 24 weeks.
Main outcomes and measures
The primary outcome was the Quality of Episodic Memory composite measure (0–100) from an online cognitive test battery CogTrack, which was administered at baseline and monthly for the next 24 weeks. Secondary outcomes included other cognitive scores from the CogTrack battery. We applied mixed effects models with a baseline test score, group, time and their interaction as fixed effects, as well as other predefined baseline covariates. The primary comparison was the group difference at week 24 based on a modified intention-to-treat principle.
Results
: The primary analysis did not show a significant group difference at 24 weeks (78.2 versus 76.8; adjusted mean difference 1.4 (95% confidence interval -0.9–3.7); effect size 0.15; p = 0.23). However, there was a significant difference in slopes during weeks 8–24 (p = 0.007); the anthocyanin group improved while the placebo group worsened. No differences were found for the secondary cognitive outcomes. Anthocyanin capsules were well-tolerated and safe to use.
Conclusion
Anthocyanin supplementation for 24 weeks was safe and well tolerated in people with MCI or cardiometabolic disorders. We found no significant group difference in episodic memory at the end of the study but statistically significant differences in slopes. Further studies are warranted to explore whether anthocyanins supplementation can reduce cognitive decline in people at increased risk of dementia.
Trial registration
ClinicalTrials.gov, (Identifier NCT03419039). http://www.clinicaltrials.gov/, NCT03419039.