The Role of Gut Microbiome on Cardiovascular Health Benefits of Dietary Lignans (CardioFlax Study).
NCT ID: NCT04179136
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2019-11-25
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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High enterolactone producer's (intervention)
lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
High enterolactone producer's (Control)
Placebo treatment matching intervention
Placebo treatment matching intervention
Placebo treatment matching intervention
Low enterolactone producer's (intervention)
lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
Low enterolactone producer's (Control)
Placebo treatment matching intervention
Placebo treatment matching intervention
Placebo treatment matching intervention
Interventions
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lignan capsules contain 300 mg flaxseed (SDG) extract
lignan capsules contain 300 mg flaxseed (SDG) extract
Placebo treatment matching intervention
Placebo treatment matching intervention
Eligibility Criteria
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Inclusion Criteria
* BMI between 18 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
Exclusion Criteria
* Hypertensive, as defined as SBP superior or equal to 140 mmHg, and CBP superior or equal to 90 mmHg
* Participants with BMI superior to 35 kg/m2, and BMI below 18 kg/m2
* Medical history of diabetes mellitus, metabolic syndrome, terminal renal failure or malignancies
* Abnormal heart rhythm (lower or higher than 60-100 bmp)
* Allergies to flaxseed 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
* Smoker Subjects
* 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.
20 Years
70 Years
FEMALE
Yes
Sponsors
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King's College London
OTHER
Responsible Party
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Principal Investigators
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Dr.Ana Rodriguez-Mateos, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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King's College London
London, , United Kingdom
Countries
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Other Identifiers
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CardioFlax study
Identifier Type: -
Identifier Source: org_study_id
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