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Intra-individual Real Life Effects of Cocoa Flavanols on Blood Pressure and Arterial Stiffness

NCT05446818 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-07-07

No results posted yet for this study

Summary

Very controlled dietary intervention studies support that individual polyphenol rich foods and isolated polyphenols can increase endothelial function and HDL cholesterol and decrease blood pressure, arterial stiffness, and LDL cholesterol even in healthy subjects. The intake of (-)-epicatechin, the major polyphenol in cocoa, was previously mechanistically linked with acute improvements in endothelial function and nitric oxide availability. A profound understanding of inter- and intra-individual variability of responses in real life are an important area of research in a world that aims at personalized nutrition and medicine. N-of-1 trials are a powerful tool allowing to study small effects even in fewer subjects and help account for intra-individual variations in responses. The overall aim of the present pilot study is to evaluate intra-and inter-individual variability of responses to cocoa flavanols in everyday life using the N-of-1 paradigm. In this pilot study, young healthy humans will monitor blood pressure, pulse wave velocity, heart rate, diet, and physical activity on 8 days using a personal and wearable devices. Each subject will undergo the 8 study days; 4 days with cocoa flavanol capsules (CF; containing 750 mg (1500 mg per day)) and 4 days with calorically matched placebo capsules (P; 0 mg cocoa flavanols) taken at the same time in the morning with breakfast and at night before going to bed. The subjects will be randomized to different treatment allocation sequences to allow blinding of volunteers and investigator; either CF-P-CF-P-CF-P-CF-P or P-CF-P-CF-P-CF-P-CF.

Conditions

  • Blood Pressure
  • Stiffness, Vascular
  • Sleep

Interventions

DIETARY_SUPPLEMENT

Cocoa flavanol (CF)

2 times per day 750 mg cocoa flavanols (each delivered in 6 CocoaVia capsules)

OTHER

Placebo (P)

2 times per day 0 mg cocoa flavanols calorically matched control (delivered in 6 identical capsules)

Sponsors & Collaborators

  • University of Surrey

    lead OTHER

Principal Investigators

  • Christian Heiss, MD · University of Surrey

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-22
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05446818 on ClinicalTrials.gov