Anthocyanin supplementation in adults at risk for dementia: a randomized controlled trial on its cardiometabolic and anti-inflammatory biomarker effects.

2025-05-02
GeroScience 48(1)
- Miguel German Borda
- Robinson Ramírez-Vélez
- Felipe Botero-Rodriguez
- Jonathan Patricio-Baldera
- Chiara de Lucia
- Ilaria Pola
- George E Barreto
- Khadija Khalifa
- Anne Katrine Bergland
- Miia Kivipelto
- Tommy Cederholm
- Henrik Zetterberg
- Nicholas J Ashton
- Clive Ballard
- Richard Siow
- Dag Aarsland

PubMed: 40314845
DOI: 10.1007/s11357-025-01669-8

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 99
Population: 99 participants aged 60-80 years with mild cognitive impairment or cardiometabolic disorders
Methods: 24-week randomized, double-blind, placebo-controlled Phase II trial; 320 mg/day of anthocyanins or placebo
Blinding: Double-blind
Duration: 24-week
Funding: Unclear

Anthocyanins are dietary flavonoids shown to have a therapeutic capacity to mitigate inflammation and oxidative stress. The present secondary analyses from the "Anthocyanins in People at Risk for Dementia Study" were aimed at (I) determining the intervention's effect on blood-based markers of cardiovascular disease and inflammation and (II) evaluating whether baseline factors such as age, sex, inflammation, or cardiometabolic score may moderate the intervention's effect on inflammatory status. This study was an ancillary, 24-week randomized, double-blind, placebo-controlled Phase II trial. Sub-sample participants (n = 99), aged 60-80 years with mild cognitive impairment or cardiometabolic disorders, were randomized to receive either 320 mg/day of anthocyanins or placebo. The biomarkers analyzed included inflammatory biomarker assessment (IL - 6, IL - 8, IL - 10, IL - 1b, TNF - α, IFN - γ), and C-reactive protein (CRP), as well as albumin, thrombocytes, cholesterol, LDL, HDL, and triglycerides, which were longitudinally compared between both groups. Baseline characteristics were balanced between the groups. ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in LDL cholesterol levels (ƞp² = 0.078; p = 0.015), cardiometabolic score (ƞp² = 0.073; p = 0.021), CRP levels (ƞp² = 0.417; p = 0.0001), IL - 6 (ƞp2 = 0.085; p = 0.015), IL - 1b (ƞp² = 0.058; p = 0.037), and Inflam z-score 5 (ƞp² = 0.059, p = 0.004). Moderation analysis demonstrated that the inflammatory score at baseline was a significant predictor of the effect of the intervention on the CRP levels. Anthocyanin supplementation reduces CRP and cardiovascular disease biomarkers in individuals at risk of dementia, especially when there is increased inflammation at baseline. ClinicalTrials.gov study identifier: NCT03419039.

Research Insights

Anthocyanins→Improved Cardiometabolic Score
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in ... cardiometabolic score (ƞp2=0.073; p=0.021)
Effect
Beneficial
Effect size
Moderate
Dose
320 mg/day
Anthocyanins→Increased HDL Cholesterol Levels
The biomarkers analyzed included ... cholesterol, LDL, HDL, and triglycerides, which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Increased Interferon-Gamma Levels
The biomarkers analyzed included inflammatory biomarker assessment (IL‑6, IL‑8, IL‑10, IL‑1b, TNF‑α, IFN‑γ), ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Increased Interleukin-10 Levels
The biomarkers analyzed included inflammatory biomarker assessment (IL‑6, IL‑8, IL‑10, IL‑1b, TNF‑α, IFN‑γ), ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced Albumin Level
The biomarkers analyzed included ... albumin, thrombocytes, ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced Blood Cholesterol
The biomarkers analyzed included ... cholesterol, LDL, HDL, and triglycerides, which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced C-Reactive Protein Levels
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in ... CRP levels (ƞp2=0.417; p=0.0001)
Effect
Beneficial
Effect size
Large
Dose
320 mg/day
Anthocyanins→Reduced Inflammatory Z-Score
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in ... Inflam z-score 5 (ƞp2=0.059, p=0.004)
Effect
Beneficial
Effect size
Moderate
Dose
320 mg/day
Anthocyanins→Reduced Interleukin-1 Beta Level
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in ... IL‑1b (ƞp2=0.058; p=0.037)
Effect
Beneficial
Effect size
Moderate
Dose
320 mg/day
Anthocyanins→Reduced Interleukin-1β Levels
The biomarkers analyzed included inflammatory biomarker assessment (IL‑6, IL‑8, IL‑10, IL‑1b, TNF‑α, IFN‑γ), ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced Interleukin-6 Levels
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in ... IL‑6 (ƞp2=0.085; p=0.015)
Effect
Beneficial
Effect size
Moderate
Dose
320 mg/day
Anthocyanins→Reduced LDL Cholesterol
ANCOVA analyses reveal 24-week differences favoring the anthocyanin treatment in LDL cholesterol levels (ƞp2=0.078; p=0.015)
Effect
Beneficial
Effect size
Moderate
Dose
320 mg/day
Anthocyanins→Reduced Platelet Counts
The biomarkers analyzed included ... albumin, thrombocytes, ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced Triglyceride Levels
The biomarkers analyzed included ... cholesterol, LDL, HDL, and triglycerides, which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day
Anthocyanins→Reduced Tumor Necrosis Factor Alpha
The biomarkers analyzed included inflammatory biomarker assessment (IL‑6, IL‑8, IL‑10, IL‑1b, TNF‑α, IFN‑γ), ... which were longitudinally compared between both groups.
Effect
Neutral
Effect size
Small
Dose
320 mg/day