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Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances

Acute and Chronic Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02949115
Enrollment
15
Registered
2016-10-31
Start date
2016-11-30
Completion date
2019-06-30
Last updated
2018-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Menopause, Obesity, Overweight

Keywords

Red beetroot, Dietary Nitrate, Polyphenols, Endothelial Function, High-Fat Meal, Overweight, Obesity, Aging, Cardiometabolic

Brief 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. 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.

Interventions

DIETARY_SUPPLEMENT70 mL red beetroot juice

1x daily intake of 70 mL red beetroot juice

DIETARY_SUPPLEMENT70 mL red beetroot juice without nitrate

1x daily intake of 70 mL red beetroot juice without nitrate

DIETARY_SUPPLEMENT70 mL placebo drink plus potassium nitrate

1x daily intake of 70 mL placebo control drink plus 489 mg potassium nitrate (300 mg nitrate)

DIETARY_SUPPLEMENT70 mL placebo drink

1x daily intake of 70 mL placebo control drink

Sponsors

Colorado State University
Lead SponsorOTHER
United States Department of Agriculture (USDA)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Postmenopausal women and men * BMI between 25 and 40 kg/m2

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Vascular endothelial function0 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.

Secondary

MeasureTime frameDescription
Heart rate0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.Heart rate will be measured by an automatic sphygmomanometer and SphygmoCor at 0 and 1, 2, and 4 hours post-meal consumption.
Nitric oxide biomarkers0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.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.
Oxidative stress biomarkers0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.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.
Pro-inflammatory biomarkers0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.Biomarkers of inflammation will be evaluating in peripheral blood mononuclear cells and biopsied venous endothelial cells at 0 and 4 hours post-meal consumption.
Blood glucose, insulin, and indices of insulin sensitivity and resistance0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.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.
Blood triglycerides0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period.Blood triglycerides will be measured by biochemical analysis at 0 and 1, 2, and 4 hours post-meal consumption.
Blood pressure0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment periodPeripheral and central blood pressure measured by an automatic sphygmomanometer and SphygmoCor at 0 and 1, 2, and 4 hours post-meal consumption.
Arterial stiffnessPre-meal consumption at baseline and 1 month for each treatment period.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).

Other

MeasureTime frameDescription
Oral and gut microbiomePre-meal consumption at baseline and 1 month for each treatment period.The role of the oral and gut microbiome in efficacy of treatments at baseline and over time will be evaluated.
Urinary polyphenols and polyphenol metabolites0 and 24 hours post-meal consumption at baseline and 1 month for each treatment period.Urinary polyphenols and metabolites will be measured by mass spectrometry at 0 and 24 hours post-meal consumption.
Blood polyphenols and polyphenol metabolites0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period.Blood polyphenols and metabolites will be measured by mass spectrometry at 0, 1, 2 and 4 hours post-meal consumption.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026