Franklin-Wilkins Building, King's College London
London, SE1 9NH, United Kingdom
NCT Number: NCT04084457
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial investigating the effects of daily blueberry (poly)phenol consumption on vascular function and cognitive performance in healthy elderly individuals. The study will be conducted at King's College London, Franklin-Wilkins Building.
Eligible subjects will be healthy males and females aged 65-80.
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Notify Me65 year–80 year
All sexes
Interventional
Not applicable
London, SE1 9NH, United Kingdom
To date no study has investigated whether daily blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, the investigators aim to directly link daily blueberry consumption with improved vascular function, increased cerebral blood flow and positive cognitive outcomes in healthy elderly individuals. The investigators will use a large group of elderly individuals' representative of a healthy population, both males and females, aged 65-80 years to evaluate the health effects of daily blueberry consumption.
The main aim is to investigate whether improvements in vascular and cognitive function previously seen after blueberry consumption can be seen following 3-months daily consumption in elderly individuals, and whether enhanced cognitive performance is correlated with increased cerebral blood flow. The investigators hypothesise that daily consumption of an anthocyanin rich blueberry drink will improve cognitive performance and vascular function, increasing cerebral blood flow, in healthy older individuals.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Powdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered.
Identical formulation as the treatment matched for fibre and vitamin C
Time frame: Baseline and 12 weeks post-intervention
Changes in flow-mediated dilation of the brachial artery (FMD) from baseline after 12-week consumption of blueberry vs control
Time frame: Baseline and 12 weeks post-intervention
Changes in cognitive function from baseline after 12-week consumption of blueberry vs control. Cognitive testing involves the participant conducting tasks administered on a tablet-style laptop. The participants will be conducting these tasks whilst cerebral blood flow measurements are taking place. The cognitive testing battery will consist of 4 tasks which are Auditory Verbal learning task, Corsi Blocks, Switching task and Serials 3's and 7's, including a mood assessment (PANAS).
Time frame: Baseline and 12 weeks post-intervention
Changes in cerebral blood flow velocity (CBFv) from baseline after 12-week consumption of blueberry vs control. Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD). Variables measured include resting and active mean blood flow velocity (cm/s).
Time frame: Baseline and 12 weeks post-intervention
Changes from baseline office systolic blood pressure (mmHg) after 12-week consumption of blueberry vs control.
Time frame: Baseline and 12 weeks post-intervention
Determine the changes in Pulse wave velocity (PWV) from baseline after 12-week consumption of blueberry vs control.
Time frame: Baseline and 12 weeks post-intervention
Changes in augmentation Index (AIx) using a Sphygmocor device post consumption of a placebo or blueberry treatment
Time frame: Baseline and 12 weeks post-intervention
Determine the effect of the blueberry extract vs Placebo on 24-hour systolic blood pressure using a monitor, at 12 weeks post consumption. Variables include mean asleep, awake and total 24 h systolic blood pressure
Time frame: Baseline and 12 weeks post-intervention
Assessment using a self-reported questionnaire using the Positive and Negative Affect Schedule (PANAS).PANAS (The Positive and Negative Affect Schedule) to measure mood, where the participants will need to answer 20 questions using a 5-point likert scale that ranges from (1) not at all to (5) extremely. Dependent variables are composite positive affect and negative affect scores obtained by summing responses to positive or negative PANAS items, respectively.
Time frame: Baseline and 12 weeks post-intervention
Determine the effect of the blueberry extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption.
Time frame: Baseline and 12 weeks post-intervention
Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours post consumption
Time frame: Baseline and 12 weeks post-intervention
Stool sample collection involving an all-in-one kit for self-collection and stabilization of microbial DNA from faeces for gut microbiome profiling.
Time frame: Baseline and 12 weeks post-intervention
Collected over a 24 hour period. Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours post consumption
Time frame: Baseline and 12 weeks post-intervention
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Time frame: Baseline and 12 weeks post-intervention
Changes in pulsatility index (PI) from baseline after 12-week consumption of blueberry vs control. Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD). Variables measured include resting and active PI (cm/s.
Time frame: Baseline and 12 weeks post-intervention
Changes from baseline office diastolic blood pressure (mmHg) after 12-week consumption of blueberry vs control.
Time frame: Baseline and 12 weeks post-intervention
Determine the effect of the blueberry extract vs Placebo on 24-hour diastolic blood pressure using a monitor, at 12 weeks post consumption. Variables include mean asleep, awake and total 24 h diastolic blood pressure
King's College London
Other
Randomised, Double-blind, Placebo Controlled, Parallel Trial Investigating the Daily Effects of Blueberry (Poly)Phenol Consumption on Vascular Function and Cognitive Performance in Healthy Elderly Individuals
Acronym: BluFlow
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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