OverweightPhase 2NCT02949115
Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances
A Phase 2 study testing 70 mL red beetroot juice and 70 mL red beetroot juice without nitrate in people with Overweight and Obesity, run by Colorado State University at 1 site in United States.
Trial summary
Aside from aging, numerous factors increase the risk for developing cardiovascular disease (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular endothelial dysfunction and other cardiometabolic disturbances (e.g. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Aging
- What is being tested?
- 70 mL red beetroot juice and 70 mL red beetroot juice without nitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jun 2019
- Phase
- Phase 2
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women and men
- BMI between 25 and 40 kg/m2
Who cannot join
- Hypertension, cardiovascular disease, diabetes, cancer, or kidney, liver, or pancreatic disease
- Individuals taking gastroesophageal reflux, antihypertensive, hypoglycemic, lipid-lowering, hormone replacement, erectile dysfunction medications or nitrates
- Participating in a weight loss program or actively trying to lose weight
- Smokers
- Heavy drinkers (> 3 drinks on any given occasion and/or > 7 drinks/week for women, or > 4 drinks on any given occasion and/or > 14 drinks/week for men)
- Allergy to meals/treatments
- Consuming > 2 servings red beetroot or beetroot juice/wk
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, 80523-1571
About this study
Official title: Acute and Chronic Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances
Aside from aging, numerous factors increase the risk for developing cardiovascular disease (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese individuals. These postprandial responses are likely largely due to activation of pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the postprandial state, this may further impair cardiovascular health in aging overweight/obese individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids, phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and their metabolites have been shown to have antioxidative, anti-inflammatory, and cardiovascular-protective effects. These effects, particularly the cardiovascular-protective effects, have been primarily attributed to its high content of nitrate since it is converted to nitric oxide independent of the vascular endothelium via the enterosalivary nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other potentially beneficial bioactive compounds and few studies have aimed to determine whether these compounds work independently, additively, or synergistically in exerting these effects. Given the findings of previously conducted research in the broad area of red beetroot juice consumption and human health, it can be suggested that: 1) acute red beetroot juice consumption may prevent or attenuate the adverse postprandial responses to consuming a high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red beetroot may improve underlying factors contributing to these exaggerated responses. Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole red beetroot juice consumption compared with its bioactive components in attenuating postprandial vascular endothelial dysfunction and adverse cardiometabolic responses to a high-fat meal; and 2) to gain insight into the underlying mechanisms responsible.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, 4-period, 4-week crossover pilot clinical trial consisting of 2 postprandial tests for each period. Overweight or obese postmenopausal women and men aged 40 to 65 will be recruited from the greater Fort Collins, CO area. After telephone prescreening, participants will report to the study site for their first visit (Screening) where they will receive verbal and written explanation of the project, provide informed consent, followed by screening assessments. Qualified participants will be scheduled for a baseline visit and randomly assigned to their respective treatments. On the second visit (Baseline) following an overnight fast, anthropometrics and blood pressure will be measured and diet and physical activity records will be collected. Subjects will ingest their respective treatment 10 min prior to consuming the high-fat test meal. Various assessments will be performed and samples collected prior to and up to 4 hours post-meal consumption. At the third visit (Final), all assessments and sample collections will be repeated at the same time points but 24 hours after consuming the last dose of their respective treatments to test chronic rather than acute effects. Subjects will undergo a 4-week washout period before crossing over to the next treatment period. This will be repeated for all 4 treatments.
- Conditions
- Overweight, Obesity, Aging, Menopause
- Being tested
- 70 mL red beetroot juice, 70 mL red beetroot juice without nitrate, 70 mL placebo drink plus potassium nitrate, 70 mL placebo drink
- Keywords
- Red beetroot, Dietary Nitrate, Polyphenols, Endothelial Function, High-Fat Meal, Overweight, Obesity, Aging, Cardiometabolic
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
70 mL red beetroot juiceDietary supplement
1x daily intake of 70 mL red beetroot juice
70 mL red beetroot juice without nitrateDietary supplement
1x daily intake of 70 mL red beetroot juice without nitrate
70 mL placebo drink plus potassium nitrateDietary supplement
1x daily intake of 70 mL placebo control drink plus 489 mg potassium nitrate (300 mg nitrate)
70 mL placebo drinkDietary supplement
1x daily intake of 70 mL placebo control drink
| Study group | Role | What they receive |
|---|---|---|
| 70 mL red beetroot juice | Experimental | 70 mL red beetroot juice naturally containing 300 mg nitrate. Receives: Dietary Supplement: 70 mL red beetroot juice |
| 70 mL placebo drink plus potassium nitrate | Active comparator | 70 mL calorie-matched placebo control drink containing 489 mg potassium nitrate to deliver 300 mg nitrate. Receives: Dietary Supplement: 70 mL placebo drink plus potassium nitrate |
| 70 mL red beetroot juice without nitrate | Active comparator | 70 mL red beetroot juice per day without nitrate. Receives: Dietary Supplement: 70 mL red beetroot juice without nitrate |
| 70 mL placebo drink | Placebo comparator | 70 mL calorie-matched placebo control drink devoid of nitrate, vitamins, minerals, and polyphenols. Receives: Dietary Supplement: 70 mL placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular endothelial function
Vascular endothelial function will be assessed using reactive hyperemia index (EndoPAT) 0 and 4 hours post-meal consumption.
Measured: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Secondary outcomes (8)
Blood glucose, insulin, and indices of insulin sensitivity and resistance
Blood glucose and insulin will be measured by biochemical analysis at 0 and 1, 2, and 4 hours post-meal consumption and indices of insulin sensitivity and resistance will be calculated.
Measured: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Blood triglycerides
Blood triglycerides will be measured by biochemical analysis at 0 and 1, 2, and 4 hours post-meal consumption.
Measured: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Blood pressure
Peripheral and central blood pressure measured by an automatic sphygmomanometer and SphygmoCor at 0 and 1, 2, and 4 hours post-meal consumption.
Measured: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period
Heart rate
Heart rate will be measured by an automatic sphygmomanometer and SphygmoCor at 0 and 1, 2, and 4 hours post-meal consumption.
Measured: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Arterial stiffness
Arterial stiffness will be assessed as carotid-femoral pulse wave velocity and augmentation index (using SphygmCor and EndoPAT) at baseline and 1 month periods (pre-meal consumption).
Measured: Pre-meal consumption at baseline and 1 month for each treatment period.
Nitric oxide biomarkers
Nitric oxide metabolites and molecules involved in nitric oxide production and bioavailability will be evaluated in saliva, blood, peripheral blood mononuclear cells, and biopsied venous endothelial cells at 0 and 1, 2, and 4 hours post-meal consumption.
Measured: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Oxidative stress biomarkers
Biomarkers of oxidative stress will be evaluating in peripheral blood mononuclear cells and biopsied venous endothelial cells at 0 and 1, 2, and 4 hours post-meal consumption.
Measured: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Pro-inflammatory biomarkers
Biomarkers of inflammation will be evaluating in peripheral blood mononuclear cells and biopsied venous endothelial cells at 0 and 4 hours post-meal consumption.
Measured: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionAug 2018
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado State University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Sarah Johnson, Colorado State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949115
- Sponsor's protocol ID
- COL00729
- Status last verified
- Nov 2018
- First submitted
- 26 Oct 2016
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Litwin NS, Van Ark HJ, Hartley SC, Michell KA, Vazquez AR, Fischer EK, Melby CL, Weir TL, Wei Y, Rao S, Hildreth KL, Seals DR, Pagliassotti MJ, Johnson SA. Impact of Red Beetroot Juice on Vascular Endothelial Function and Cardiometabolic Responses to a High-Fat Meal in Middle-Aged/Older Adults with Overweight and Obesity: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. Curr Dev Nutr. 2019 Oct 17;3(11):nzz113. doi: 10.1093/cdn/nzz113. eCollection 2019 Nov.
PubMed 31737860
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances
- ClinicalTrials.gov ID
- NCT02949115
- Acronym / sponsor ID
- COL00729
- Conditions
- Overweight, Obesity, Aging, Menopause
- Keywords
- Red beetroot, Dietary Nitrate, Polyphenols, Endothelial Function, High-Fat Meal, Overweight, Obesity, Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Colorado State UniversityUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Nov 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 31 Oct 2016 (estimated)
- 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.
Aside from aging, numerous factors increase the risk for developing cardiovascular disease (CVD) including diet and nutrition. High-fat meal consumption induces postprandial vascular endothelial dysfunction and other cardiometabolic disturbances (e.g. dyslipidemia and hyperglycemia) in normal weight individuals and is exacerbated in overweight/obese individuals. These postprandial responses are likely largely due to activation of pro-inflammatory and pro-oxidant pathways. Given that much of the day is spent in the postprandial state, this may further impair cardiovascular health in aging overweight/obese individuals. Interventions that attenuate these responses are needed. Red beetroot (Beta vulgaris L.) is an excellent source of bioactive compounds including nitrate, flavonoids, phenolic acids, betalains, carotenoids, and ascorbic acid. These bioactive compounds and their metabolites have been shown to have antioxidative, anti-inflammatory, and cardiovascular-protective effects. These effects, particularly the cardiovascular-protective effects, have been primarily attributed to its high content of nitrate since it is converted to nitric oxide independent of the vascular endothelium via the enterosalivary nitrate-nitrite-nitric oxide pathway. However, red beetroot juice contains a number of other potentially beneficial bioactive compounds and few studies have aimed to determine whether these compounds work independently, additively, or synergistically in exerting these effects. Given the findings of previously conducted research in the broad area of red beetroot juice consumption and human health, it can be suggested that: 1) acute red beetroot juice consumption may prevent or attenuate the adverse postprandial responses to consuming a high-fat meal in individuals with exaggerated responses; and 2) chronic consumption of red beetroot may improve underlying factors contributing to these exaggerated responses. Accordingly, this project aims to: 1) investigate the efficacy of acute and chronic whole red beetroot juice consumption compared with its bioactive components in attenuating postprandial vascular endothelial dysfunction and adverse cardiometabolic responses to a high-fat meal; and 2) to gain insight into the underlying mechanisms responsible.
Detailed description
This is a randomized, double-blind, placebo-controlled, 4-period, 4-week crossover pilot clinical trial consisting of 2 postprandial tests for each period. Overweight or obese postmenopausal women and men aged 40 to 65 will be recruited from the greater Fort Collins, CO area. After telephone prescreening, participants will report to the study site for their first visit (Screening) where they will receive verbal and written explanation of the project, provide informed consent, followed by screening assessments. Qualified participants will be scheduled for a baseline visit and randomly assigned to their respective treatments. On the second visit (Baseline) following an overnight fast, anthropometrics and blood pressure will be measured and diet and physical activity records will be collected. Subjects will ingest their respective treatment 10 min prior to consuming the high-fat test meal. Various assessments will be performed and samples collected prior to and up to 4 hours post-meal consumption. At the third visit (Final), all assessments and sample collections will be repeated at the same time points but 24 hours after consuming the last dose of their respective treatments to test chronic rather than acute effects. Subjects will undergo a 4-week washout period before crossing over to the next treatment period. This will be repeated for all 4 treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 70 mL red beetroot juice | Experimental | Dietary Supplement: 70 mL red beetroot juice70 mL red beetroot juice naturally containing 300 mg nitrate. |
| 70 mL placebo drink plus potassium nitrate | Active comparator | Dietary Supplement: 70 mL placebo drink plus potassium nitrate70 mL calorie-matched placebo control drink containing 489 mg potassium nitrate to deliver 300 mg nitrate. |
| 70 mL red beetroot juice without nitrate | Active comparator | Dietary Supplement: 70 mL red beetroot juice without nitrate70 mL red beetroot juice per day without nitrate. |
| 70 mL placebo drink | Placebo comparator | Dietary Supplement: 70 mL placebo drink70 mL calorie-matched placebo control drink devoid of nitrate, vitamins, minerals, and polyphenols. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal women and men
- BMI between 25 and 40 kg/m2
Key exclusion criteria (7 listed)
- Hypertension, cardiovascular disease, diabetes, cancer, or kidney, liver, or pancreatic disease
- Individuals taking gastroesophageal reflux, antihypertensive, hypoglycemic, lipid-lowering, hormone replacement, erectile dysfunction medications or nitrates
- Participating in a weight loss program or actively trying to lose weight
- Smokers
- Heavy drinkers (> 3 drinks on any given occasion and/or > 7 drinks/week for women, or > 4 drinks on any given occasion and/or > 14 drinks/week for men)
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 |
|---|---|---|
| 70 mL red beetroot juice1x daily intake of 70 mL red beetroot juice | Dietary supplement | 70 mL red beetroot juice |
| 70 mL red beetroot juice without nitrate1x daily intake of 70 mL red beetroot juice without nitrate | Dietary supplement | 70 mL red beetroot juice without nitrate |
| 70 mL placebo drink plus potassium nitrate1x daily intake of 70 mL placebo control drink plus 489 mg potassium nitrate (300 mg nitrate) | Dietary supplement | 70 mL placebo drink plus potassium nitrate |
| 70 mL placebo drink1x daily intake of 70 mL placebo control drink | Dietary supplement | 70 mL placebo drink |
Primary outcome
Vascular endothelial function
Time frame: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Vascular endothelial function will be assessed using reactive hyperemia index (EndoPAT) 0 and 4 hours post-meal consumption.
8 secondary outcomes
Blood glucose, insulin, and indices of insulin sensitivity and resistance
Time frame: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Blood triglycerides
Time frame: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Blood pressure
Time frame: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period
Heart rate
Time frame: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Arterial stiffness
Time frame: Pre-meal consumption at baseline and 1 month for each treatment period.
Nitric oxide biomarkers
Time frame: 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Oxidative stress biomarkers
Time frame: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Pro-inflammatory biomarkers
Time frame: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2018.
- Derived from this study: PubMed 31737860Litwin NS, Van Ark HJ, Hartley SC, Michell KA, Vazquez AR, Fischer EK, Melby CL, Weir TL, Wei Y, Rao S, Hildreth KL, Seals DR, Pagliassotti MJ, Johnson SA. Impact of Red Beetroot Juice on Vascular Endothelial Function and Cardiometabolic Responses to a High-Fat Meal in Middle-Aged/Older Adults with Overweight and Obesity: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. Curr Dev Nutr. 2019 Oct 17;3(11):nzz113. doi: 10.1093/cdn/nzz113. eCollection 2019 Nov.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 70 mL red beetroot juice and 70 mL red beetroot juice without nitrate in people with Overweight and Obesity, run by Colorado State University at 1 site in United States.
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 2 inclusion and 7 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 13 Nov 2018. 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 States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Vascular endothelial function (time frame: 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02949115, which also lists 1 linked publication.
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 13 Nov 2018.