NCT07265869

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
Last Updated

December 5, 2025

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

November 19, 2025

Last Update Submit

December 1, 2025

Conditions

Keywords

vascular functionendothelial functionflow-mediated dilatationflavanolscocoaflavonoidspolyphenolssittingsedentaryageingolder adultsfunctional Near-Infrared Spectroscopy

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

EXPERIMENTAL

12 g of fat-reduced natural cocoa powder containing 695 mg of total flavanols, including 150 mg (-)-epicatechin

Dietary Supplement: High-flavanol cocoa powder

Low-flavanol cocoa powder

PLACEBO COMPARATOR

12 g of fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols

Dietary Supplement: Low-flavanol cocoa powder

Interventions

Low-flavanol cocoa powderDIETARY_SUPPLEMENT

12 g of a fat-reduced alkalized cocoa powder containing 5.6 mg of total flavanols

Low-flavanol cocoa powder
High-flavanol cocoa powderDIETARY_SUPPLEMENT

12 g of a fat-reduced natural cocoa powder containing 150 mg of (-)-epicatechin, and 695 mg of total flavanols

High-flavanol cocoa powder

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

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

Locations