Can Cocoa Flavanols Protect Endothelial Function During Prolonged Sitting in Healthy Older Adults?
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
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Aug 2022
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2023
CompletedFirst Submitted
Initial submission to the registry
November 19, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedDecember 5, 2025
October 1, 2025
1.1 years
November 19, 2025
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow-mediated dilatation of the superficial femoral artery
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 Outcomes (12)
Flow-mediated dilatation of the brachial artery
Change from pre-intervention baseline to 2 hours post-intervention/ 2hours post sitting
Tissue oxygenation index (TOI) of Gastrocnemius skeletal muscle
Change from pre-intervention baseline to 2 hours post-intervention / 2 hours of sitting
Normalized haemoglobin index (nTHI) of the gastrocnemius skeletal muscle
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
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
Post-intervention time points considered during sitting were 0 min , 10 min, 60 min and 120 min.
- +7 more secondary outcomes
Study Arms (2)
High-flavanol cocoa powder
EXPERIMENTAL12 g of fat-reduced natural cocoa powder containing 695 mg of total flavanols, including 150 mg (-)-epicatechin
Low-flavanol cocoa powder
PLACEBO COMPARATOR12 g of fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols
Interventions
12 g of a fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols
12 g of a fat-reduced natural cocoa powder containing 150 mg of (-)-epicatechin, and 695 mg of total flavanols
Eligibility Criteria
You may qualify if:
- Males and females
- aged 65 or more
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Sport, Exercise & Rehabilitation Sciences, University of Birmingham
Birmingham, West Midlands, B15 2TT, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2025
First Posted
December 5, 2025
Study Start
August 2, 2022
Primary Completion
August 24, 2023
Study Completion
August 24, 2023
Last Updated
December 5, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share