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| Name | Class |
|---|---|
| VDF FutureCeuticals Inc. | INDUSTRY |
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The goal of this randomized, double-blind, placebo-controlled, cross-over trial is to investigate the effects of beetroot-derived betalains on cardiovascular health, sleep and quality of life in healthy middle-aged individuals. The main question[s] it aims to answer are:
Participants will be involved with the following:
Researchers will compare results between the intervention versus the placebo group to see if any of the study outcomes are significantly different.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betalains then placebo | Experimental | Daily consumption of 1 betalain capsule (25 mg betalains) for 28 days, then crossing over to the placebo |
|
| Placebo then betalains | Experimental | Daily consumption of 1 placebo capsule (0 mg betalains) for 28 days, then crossing over to the betalains |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betalains | Dietary Supplement | Betalains extracted from red beetroot (Beta vulgaris) encapsulated in edible capsules. (25 mg betalains per capsule) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow-mediated dilation (FMD) of the brachial artery after 4 weeks consumption of 25 mg betalains | Baseline & 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in flow mediated dilation (FMD) of the brachial artery | Determine changes in flow-mediated dilation (FMD) of the brachial artery at 90 minutes after consumption of 25 mg betalains | Baseline & 90 minutes |
| Changes in blood pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in plasma erythropoietin | Determine changes in plasma erythropoietin at 90 minutes and 4 weeks after consumption of 25 mg betalains | Baseline, 90 minutes and 4 weeks |
| Changes in red blood cell deformability |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Rodriguez-Mateos, PhD | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metabolic Research Unit (King's College London) | London | London | SE1 9NH | United Kingdom |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D050858 | Betalains |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Placebo | Other | Placebo capsules containing rice hulls. (0 mg betalains per capsule) |
|
Determine changes in systolic and diastolic blood pressure at 90 minutes and 4 weeks after consumption of 25 mg betalains
| Baseline, 90 minutes and 4 weeks |
| Changes in arterial stiffness | Determine changes in pulse-wave velocity and pulse-wave analysis after 4 weeks of consumption of 25 mg betalains using applanation tonometry on SphygmoCor system. | Baseline and 4 weeks |
| Changes in heart rate | Determine changes in heart rate at 90 minutes and 4 weeks after consumption of 25 mg betalains | Baseline, 90 minutes and 4 weeks |
| Changes in sleep quality (sleep duration, percent of light, deep and REM sleep and etc.) | Determine changes in sleep quality (sleep duration, percent of light, deep and REM sleep etc.) after 4 weeks of consumption of 25 mg betalains using wearable activity tracker. | Baseline and 4 weeks |
| Changes in quality of life (quality of life scores and physical activity) | Determine changes in quality of life after 4 weeks consumption of 25 mg betalains via WHOQoL-100 questionnaire, Short Form-36 (SF-36) survey, and physical activity on wearable activity tracker. | Baseline and 4 weeks |
| Changes in blood flow velocity | Determine changes in blood flow velocity at 90 minutes and 4 weeks after consumption of 25 mg betalains | Baseline, 90 minutes and 4 weeks |
Determine changes in red blood cell deformability at 90 minutes and 4 weeks after consumption of 25 mg betalains measured via osmotic gradient ektacytometry.
| Baseline, 90 minutes and 4 weeks |
| Plasma betalains and polyphenol metabolites | Measured by liquid chromotography-mass spectrometry (LC/MS) post-consumption. | Baseline, 90 minutes and 4 weeks |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014443 | Tyrosine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |