HealthyStratiPolNCT03573414
Gut Microbial Metabolism of Polyphenols and Cardiovascular Health (StratiPol) (Stratification Study)
A study testing raspberry powder, milled flaxseed and soy milk in people with Healthy, run by King's College London at 1 site in United Kingdom.
Trial summary
There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- raspberry powder, milled flaxseed and soy milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jul 2018to Sep 2022
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy men and women aged 20-70 years
- BMI between 18.5 and 35 kg/m2
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
- Signed informed consent form
Who cannot join
- Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, defined as 140/90mmHg or higher
- Obese participants with BMI superior or equal to 35 kg/m2
- Underweight participants defined by a BMI inferior to 18.5 kg/m2
- Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
- Abnormal heart rhythm (lower or higher than 60-100 bpm)
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- Allergies to berries or other significant food allergy
- Subjects under medication that can affect the cardiovascular system or on vitamin/dietary supplements.
- Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
- Subjects who reported participant in another study within one month before the study start
- Subjects who smoke an irregular amount of cigarettes per day
- Pregnant women or planning to become pregnant in the next 6 months
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London, Department of Nutritional Sciences
London, SE1 9NH
Dr. Ana Rodriguez-mateos, PhD, ana.rodriguez-mateos@kcl.ac.uk
About this study
Official title: Gut Microbial Metabolism of Polyphenols and Cardiovascular Health
There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. The objective of this study is to investigate the association between polyphenol microbiota metabolism and cardiovascular health.
The participants (n=250) with age range between 20 to 70 years old health overweight men and women. The participants will consume a polyphenol rich breakfast for three days (consisting on milled flaxseed, raspberry powder and soy milk). The participants will provide the investigators with urine and blood samples for polyphenol analysis. Cardiovascular measurements such as PWV, AIx, Blood Pressure and FMD will be performed at baseline and after 72h.
- Conditions
- Healthy
- Being tested
- raspberry powder, milled flaxseed and soy milk
- Keywords
- Cardiovascular system, Polyphenols
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
raspberry powder, milled flaxseed and soy milkOther
- The participants will consume a breakfast consisting of 30 g of milled flaxseed, 40 g of raspberry powder and 250 ml of soy milk for 3 days
- The participants will provide blood and urine samples
| Study group | Role | What they receive |
|---|---|---|
| Healthy men and women | Experimental | Intervention:
2*breakfast containing 40 g of raspberry powder, 30 g milled flax seeds and 250 mL of soy Milk. Receives: Other: raspberry powder, milled flaxseed and soy milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.
To examine ellagitannins, lignans and isoflavones metabolites levels in urine and plasma assessed by liquid chromatography - mass spectrometer (LCMS) post 3 days consumption of high polyphenol breakfast contain 40 g raspberry powder, 30 g milled flaxseed and 250 mL soy milk to establish metabotypes.
Measured: 1-3 days
Secondary outcomes (6)
Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast.
Determine the effect post 3 day consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on endothelium-dependent flow mediated dilation (FMD) of the brachial artery, including diameter and flow velocity using Ultra sound device.
Measured: Baseline 0 and 72 hours.
Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast
Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on arterial stiffness measured as pulse wave velocity (PWV) using a Sphygmocor device.
Measured: Baseline 0 and 72 hours.
Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast.
Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on arterial stiffness measured Augmentation index ( AIX) using a Sphygmocor device.
Measured: Baseline 0 and 72 hours.
Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast.
Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on central and peripheral systolic and diastolic blood pressure.
Measured: Baseline 0 and 72 hours.
Changes in heart rate after 3 days consumption of high polyphenol breakfast.
Determine the effect post 3 days of consumption of a polyphenol rich breakfast containing raspberry ellagitannins, flaxseed lignans and soy milk isoflavones on heart rate.
Measured: Baseline 0 and 72 hours.
Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones.
Determine the bioavailability of polyphenols post 3 days of consumption of a polyphenol rich breakfast in blood and urine samples measured by liquid chromatograph - mass spectrometry (LCMS)
Measured: Baseline 0 and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start2 Jul 2018
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Washington Red Raspberry Commission
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
- Investigators
- Dr. Ana Rodriguez-Mateos, PhD, Principal investigator, ana.rodriguez-mateos@kcl.ac.uk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573414
- Sponsor's protocol ID
- Stratification Study
- Acronym
- StratiPol
- Status last verified
- Mar 2022
- First submitted
- 1 Jun 2018
- Last updated
- 31 Mar 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbial Metabolism of Polyphenols and Cardiovascular Health
- ClinicalTrials.gov ID
- NCT03573414
- Acronym / sponsor ID
- StratiPol / Stratification Study
- Conditions
- Healthy
- Keywords
- Cardiovascular system, Polyphenols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Washington Red Raspberry Commission
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 29 Jun 2018 (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.
There is increasing interest in the effects of various food derived polyphenols on cardiovascular health. Several studies have demonstrated improvements in vascular function after intake of polyphenol rich foods. The objective of this study is to investigate the association between polyphenol microbiota metabolism and cardiovascular health.
The participants (n=250) with age range between 20 to 70 years old health overweight men and women. The participants will consume a polyphenol rich breakfast for three days (consisting on milled flaxseed, raspberry powder and soy milk). The participants will provide the investigators with urine and blood samples for polyphenol analysis. Cardiovascular measurements such as PWV, AIx, Blood Pressure and FMD will be performed at baseline and after 72h.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy men and women | Experimental | Other: raspberry powder, milled flaxseed and soy milkIntervention: 2*breakfast containing 40 g of raspberry powder, 30 g milled flax seeds and 250 mL of soy Milk. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men and women aged 20-70 years
- BMI between 18.5 and 35 kg/m2
- Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
- Are able to understand the nature of the study
- Able to give signed written informed consent
Key exclusion criteria (13 listed)
- Medical history of cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
- Hypertensive, defined as 140/90mmHg or higher
- Obese participants with BMI superior or equal to 35 kg/m2
- Underweight participants defined by a BMI inferior to 18.5 kg/m2
- Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
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 |
|---|---|---|
| raspberry powder, milled flaxseed and soy milk* The participants will consume a breakfast consisting of 30 g of milled flaxseed, 40 g of raspberry powder and 250 ml of soy milk for 3 days * The participants will provide blood and urine samples | Other | Healthy men and women |
Primary outcome
Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast.
Time frame: 1-3 days
To examine ellagitannins, lignans and isoflavones metabolites levels in urine and plasma assessed by liquid chromatography - mass spectrometer (LCMS) post 3 days consumption of high polyphenol breakfast contain 40 g raspberry powder, 30 g milled flaxseed and 250 mL soy milk to establish metabotypes.
6 secondary outcomes
Changes in flow- mediated dilation after 3 days consumption of high polyphenol breakfast.
Time frame: Baseline 0 and 72 hours.
Changes in Pulse Wave Velocity (PWV) after 3 days consumption of high polyphenol. breakfast
Time frame: Baseline 0 and 72 hours.
Changes in augmentation Index (AIx) after 3 days consumption of high polyphenol breakfast.
Time frame: Baseline 0 and 72 hours.
Changes in office Blood pressure after 3 days consumption of high polyphenol breakfast.
Time frame: Baseline 0 and 72 hours.
Changes in heart rate after 3 days consumption of high polyphenol breakfast.
Time frame: Baseline 0 and 72 hours.
Plasma and Urine polyphenol metabolites levels for ellagitannins, lignans and isoflavones.
Time frame: Baseline 0 and 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Dr. Ana Rodriguez-Mateos, PhD principal investigator
ana.rodriguez-mateos@kcl.ac.uk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing raspberry powder, milled flaxseed and soy milk in people with Healthy, run by King's College London 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 31 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Casani-Cubel, MBBS (+44 (0) 20 7848 4162, julia.casani@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma and 24 h urine gut microbial polyphenol metabolites after high polyphenol breakfast. (time frame: 1-3 days). 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 31 Mar 2022.