Blood PressureNCT05446818
Intra-individual Real Life Effects of Cocoa Flavanols on Blood Pressure and Arterial Stiffness
A study testing Cocoa flavanol (CF) in people with Blood Pressure and Stiffness, Vascular, run by University of Surrey at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Stiffness, Vascular, Sleep
- What is being tested?
- Cocoa flavanol (CF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Apr 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Body mass index <30 kg/m2
- Age <45 years
Who cannot join
- Diabetes mellitus
- Symptoms of acute infection
- Cardiac arrhythmia
- Active malignancy
- Clinical signs or symptoms of cardiovascular disease including:
- Angina pectoris
Show all 12Show fewer
- Shortness of breath
- Palpitations
- Syncopes
- Claudication
- Active vasoactive medication
- Vitamin supplements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-individual Real Life Effects of Cocoa Flavanols on Blood Pressure and Arterial Stiffness Using Personal Devices in Healthy Humans: Series of Repeated Cross-over Randomized Controlled Double-blind N-of-1 Pilot Studies
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.
Read the detailed description
Background: 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. However, the clinical intervention studies were performed in tightly controlled experimental settings and variability of individual responses were not investigated. 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. N-of-1 trials in clinical medicine are multiple crossover trials, usually randomized and often blinded, conducted in a single patient.
Aim, hypothesis, objectives: 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. It is the hypothesis that cocoa flavanols decrease blood pressure and arterial stiffness in everyday life of healthy individuals. The objectives to investigate the aim are (1) to test the effect of CF using wearable devices repeatedly measuring blood pressure, arterial stiffness, and heart rate in healthy individuals participating in in every days life, (2) to explore intra-and inter-individual variability in responses by repeatedly testing responses in the same individuals, and (3) to test different statistical models taking repeated measurements in the same subject into account.
Methods: 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. Blood pressure and heart rate will be measured by a standard upper arm blood pressure cuff and estimated by a fitness wristband and pulse wave velocity via a finger device in 30 min intervals for 3 h starting after morning treatment ingestion followed by hourly intervals until going to bed.
- Conditions
- Blood Pressure, Stiffness, Vascular, Sleep
- Being tested
- Cocoa flavanol (CF), Placebo (P)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa flavanol (CF)Dietary supplement
2 times per day 750 mg cocoa flavanols (each delivered in 6 CocoaVia capsules)
Placebo (P)Other
2 times per day 0 mg cocoa flavanols calorically matched control (delivered in 6 identical capsules)
| Study group | Role | What they receive |
|---|---|---|
| Flavanol first | Active comparator | Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: CF-P-CF-P-CF-P-CF-P Receives: Dietary Supplement: Cocoa flavanol (CF); Other: Placebo (P) |
| Placebo first | Active comparator | Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: P-CF-P-CF-P-CF-P-CF Receives: Dietary Supplement: Cocoa flavanol (CF); Other: Placebo (P) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure
Standard upper arm cuff (day) and wrist band (day and night)
Measured: Measurements over 24 hours
Change in arterial stiffness
Pulse wave velocity by finger clip (iHeart)
Measured: Measurements over 24 hours
Change in heart rate
Fitness bracelet
Measured: Measurements over 24 hours
Secondary outcomes (1)
Physical activity
Steps measured on fitness bracelet
Measured: Assessed over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start22 Apr 2019
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Series of Repeated Cross-over Randomized Controlled Double-blind N-of-1 Pilot Studies; each subject receives 4 times treatment and 4 times placebo
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Heiss, MD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446818
- Sponsor's protocol ID
- FER-1819-040
- Status last verified
- May 2021
- First submitted
- 26 Apr 2019
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Real Life Effects of Cocoa Flavanols on Blood Pressure and Arterial Stiffness Using Personal Devices in Healthy Humans: Series of Repeated Cross-over Randomized Controlled Double-blind N-of-1 Pilot Studies
- ClinicalTrials.gov ID
- NCT05446818
- Acronym / sponsor ID
- FER-1819-040
- Conditions
- Blood Pressure, Stiffness, Vascular, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: 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. However, the clinical intervention studies were performed in tightly controlled experimental settings and variability of individual responses were not investigated. 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. N-of-1 trials in clinical medicine are multiple crossover trials, usually randomized and often blinded, conducted in a single patient.
Aim, hypothesis, objectives: 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. It is the hypothesis that cocoa flavanols decrease blood pressure and arterial stiffness in everyday life of healthy individuals. The objectives to investigate the aim are (1) to test the effect of CF using wearable devices repeatedly measuring blood pressure, arterial stiffness, and heart rate in healthy individuals participating in in every days life, (2) to explore intra-and inter-individual variability in responses by repeatedly testing responses in the same individuals, and (3) to test different statistical models taking repeated measurements in the same subject into account.
Methods: 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. Blood pressure and heart rate will be measured by a standard upper arm blood pressure cuff and estimated by a fitness wristband and pulse wave velocity via a finger device in 30 min intervals for 3 h starting after morning treatment ingestion followed by hourly intervals until going to bed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Series of Repeated Cross-over Randomized Controlled Double-blind N-of-1 Pilot Studies; each subject receives 4 times treatment and 4 times placebo
| Arm | Type | Receives |
|---|---|---|
| Flavanol first | Active comparator | Dietary Supplement: Cocoa flavanol (CF), Other: Placebo (P)Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: CF-P-CF-P-CF-P-CF-P |
| Placebo first | Active comparator | Dietary Supplement: Cocoa flavanol (CF), Other: Placebo (P)Subjects will receive over 8 days both cocoa flavanols (CF) and placebo (P) capsules on alternating days. Sequence of this arm is: P-CF-P-CF-P-CF-P-CF |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- Body mass index <30 kg/m2
- Age <45 years
Key exclusion criteria (12 listed)
- Diabetes mellitus
- Symptoms of acute infection
- Cardiac arrhythmia
- Active malignancy
- Clinical signs or symptoms of cardiovascular disease including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocoa flavanol (CF)2 times per day 750 mg cocoa flavanols (each delivered in 6 CocoaVia capsules) | Dietary supplement | Flavanol first, Placebo first |
| Placebo (P)2 times per day 0 mg cocoa flavanols calorically matched control (delivered in 6 identical capsules) | Other | Flavanol first, Placebo first |
Primary outcome
Change in systolic and diastolic blood pressure
Time frame: Measurements over 24 hours
Standard upper arm cuff (day) and wrist band (day and night)
Change in arterial stiffness
Time frame: Measurements over 24 hours
Pulse wave velocity by finger clip (iHeart)
Change in heart rate
Time frame: Measurements over 24 hours
Fitness bracelet
1 secondary outcome
Physical activity
Time frame: Assessed over 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Heiss, MD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cocoa flavanol (CF) in people with Blood Pressure and Stiffness, Vascular, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure (time frame: Measurements over 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.