Can Cocoa Flavanols Protect Endothelial Function During Prolonged Sitting in Healthy Older Adults?

December 1, 2025 updated by: University of Birmingham

A Placebo-controlled, Randomized, Double-masked, Cross-over Acute Intervention Study Investigating the Effects of Cocoa Flavanols on Peripheral Endothelial Function in the Context of Prolonged Sitting in Healthy Older Adults

Sitting time is high in older adults and has been shown to temporarily impair endothelial function and blood pressure. Flavanols, plant-derived compounds, acutely enhance endothelial function and reduce Blood pressure in older adults. The aim of this study is to investigate whether acute ingestion of cocoa flavanols can improve peripheral endothelial function and blood pressure during prolonged sitting in healthy older adults.

In a randomised, double-blinded, cross-over, placebo-controlled human study, 20 healthy older adults will consume either a high-flavanol (695 mg) or low-flavanol (5.6 mg) cocoa beverage immediately before a 2-hour sitting bout. Flow-mediated dilation (FMD) of the superficial femoral (SFA; primary outcome) and brachial (BA) arteries, and blood pressure, were assessed before and after sitting. Microvasculature haemodynamics were assessed in the gastrocnemius before, during, and after sitting. It is hypothesized that the high flavanol cocoa will prevent declines in brachial and superficial femoral Flow-mediated dilatation post sitting.

Study Overview

Detailed Description

Older individuals are estimated to spend more than 10 hours in their waking day in sedentary activities , which can include sitting bouts lasting up to 5.4 hours/day . Greater sedentary time was found to be associated with a significantly increased risk of cardiovascular diseases and all-cause mortality. Several experimental studies have shown that even just one isolated episode of prolonged sitting (from 1 to 6 hours) has detrimental effects on human endothelial function, as measured by flow-mediated dilation (FMD).

Flavonoid-rich foods are typically consumed in high amounts in cardioprotective diets, with evidence from both observational and Randomised Controlled Trials showing flavonoids to improve biomarkers of cardiovascular health. Flavanols, a sub-group of flavonoids present in unprocessed cocoa, have been extensively shown to act quickly within the vasculature, improving both brachial Flow-mediated dilatation and lower-limb common femoral artery (CFA) Flow-mediated dilatation within 2 hours of intake in older adults.

The aim of the current study is to examine whether acute consumption of cocoa flavanols prior to a 2-hour bout of uninterrupted sitting can be beneficial in improving endothelial function (as measured by Flow mediated dilatation) in the upper-limb Brachial Artery (BA) and lower-limb Superficial Femoral Artery (SFA) in older adults, as well as downstream, muscle microvascular function. We will further investigate whether cocoa flavanols can prevent sitting-induced increases in blood pressure in older adults. We hypothesise that cocoa flavanols would be effective at rescuing upper- and lower-limb Flow-mediated dilatation and improve blood pressure during uninterrupted sitting in older age

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TT
        • School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males and females
  • aged 65 or more

Exclusion Criteria:

  • history or symptoms of cardiovascular, renal, pulmonary, metabolic, or neurologic disease, hypertension (blood pressure higher than 140/90 mm Hg, based on recent guidelines), diabetes mellitus, anaemia, asthma, immune conditions, or high cholesterol.
  • smoker
  • individuals who were on weight-reducing diets
  • individuals taking anticoagulants,
  • had recently undergone prolonged bed-rest periods
  • have been on antibiotics in the previous 3 months
  • have an infection at present (e.g. cold) or viral infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-flavanol cocoa powder
12 g of fat-reduced natural cocoa powder containing 695 mg of total flavanols, including 150 mg (-)-epicatechin
12 g of a fat-reduced natural cocoa powder containing 150 mg of (-)-epicatechin, and 695 mg of total flavanols
Placebo Comparator: Low-flavanol cocoa powder
12 g of fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols
12 g of a fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated dilatation of the superficial femoral artery
Time Frame: Change from pre-intervention baseline to 2 hours post intervention /2 hours post sitting
Flow-mediated dilatation (FMD) of the superficial femoral artery. Expressed as percent FMD: change in brachial diameter from baseline to peak dilation following 5 minutes of arterial occlusion. Brachial artery diameter and blood flow will be measured using Doppler ultrasonography (uSmart 3300, Terason).
Change from pre-intervention baseline to 2 hours post intervention /2 hours post sitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated dilatation of the brachial artery
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/ 2hours post sitting
Flow-mediated dilatation (FMD) of the brachial artery. Expressed as percent FMD: change in brachial diameter from baseline to peak dilation following 5 minutes of arterial occlusion. Brachial artery diameter and blood flow will be measured using Doppler ultrasonography (uSmart 3300, Terason).
Change from pre-intervention baseline to 2 hours post-intervention/ 2hours post sitting
Tissue oxygenation index (TOI) of Gastrocnemius skeletal muscle
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Tissue Oxygenation Index (percent TOI) will be assessed by functional Near-Infrared Spectroscopy (fNIRS) on the medial head of the gastrocnemius muscle during 5 min of superficial femoral arterial occlusion and 5 min of post-occlusion (reactive hyperaemia). The NIRS device measures changes in chromophore concentrations of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), providing depth-resolved measures of total tissue oxygen saturation.
Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Normalized haemoglobin index (nTHI) of the gastrocnemius skeletal muscle
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Normalized haemoglobin index (relative value of total haemoglobin normalised to the initial value, nTHI) content (a.u.) will be assessed by functional Near-Infrared Spectroscopy (fNIRS) on the medial head of the gastrocnemius muscle during 5 minutes of superficial femoral arterial occlusion and 5 minutes of post-occlusion (reactive hyperaemia).
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Tissue oxygenation index (TOI) of Gastrocnemius skeletal muscle during 2 hours of sitting
Time Frame: Post-intervention time points considered during sitting were 0 , 10 , 60 and 120 minutes.
Tissue Oxygenation Index (percent TOI) will be assessed by functional Near-Infrared Spectroscopy (fNIRS) on the medial head of the gastrocnemius muscle continuously during 2 hours of sitting. The NIRS device measures changes in chromophore concentrations of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb), providing depth-resolved measures of total tissue oxygen saturation. Post-intervention time points considered during sitting were 0 minutes , 10 minutes, 60 minutes, and 120 minutes. For each time point, data were averaged over a 60-second period.
Post-intervention time points considered during sitting were 0 , 10 , 60 and 120 minutes.
Normalized haemoglobin index (nTHI) of Gastrocnemius skeletal muscle during 2 hours of sitting
Time Frame: Post-intervention time points considered during sitting were 0 min , 10 min, 60 min and 120 min.
Normalized haemoglobin index (relative value of total haemoglobin normalised to the initial value, nTHI) content (a.u.) will be assessed by functional Near-Infrared Spectroscopy (fNIRS) on the medial head of the gastrocnemius muscle continuously during 2 hours of sitting. Post-intervention time points considered during sitting were 0 min , 10 min, 60 min, and 120 min. For each time point, data were averaged over a 60-second period.
Post-intervention time points considered during sitting were 0 min , 10 min, 60 min and 120 min.
Brachial Systolic Blood Pressure (SBP)
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Resting systolic blood pressure (mmHg) will be measured using an automated oscillometric blood pressure monitor, with a cuff attached to the right upper arm, following at least 10 minutes rest.
Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Brachial Diastolic Blood Pressure (DBP)
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Resting diastolic blood pressure (mmHg) will be measured using an automated oscillometric blood pressure monitor, with a cuff attached to the right upper arm, following at least 10 minutes rest.
Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Heart Rate
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Resting Heart Rate (beats per minute) will be measured using an automated oscillometric blood pressure monitor, with a cuff attached to the right upper arm, following at least 10 minutes rest.
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Resting Superficial Femoral Artery Blood Flow
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Superficial Femoral Artery Blood Flow velocity (ml min-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software. Superficial femoral artery blood flow is calculated using Superficial femoral artery blood velocity and diameter during 1 minute of recording in a resting state
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Resting Brachial Artery Blood Flow
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Resting Brachial Artery Blood Flow velocity (ml min-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software. Brachial Artery blood flow is calculated using brachial artery blood velocity and diameter during1 minute of recording in a resting state
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Superficial Femoral Artery Shear Rate
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Superficial Femoral Artery Shear Rate shear rate (s-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software, during 1 minute in the resting state
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Brachial Artery Shear Rate
Time Frame: Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting
Brachial Artery Shear Rate shear rate (s-1) will be measured using Doppler ultrasonography (uSmart 3300, Terason) interfaced with the Quipu analysis software, during 1 minute in the resting state
Change from pre-intervention baseline to 2 hours post-intervention/2 hours sitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

August 24, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

December 1, 2025

First Posted (Actual)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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