Obesity Clinical Trial
Official title:
Acute and Chronic Effects of Red Beetroot Juice on High-Fat Meal-Induced Endothelial Dysfunction and Cardiometabolic Disturbances
Verified date | November 2018 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 15 |
Est. completion date | June 2019 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Department of Food Science and Human Nutrition, Colorado State University | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University | United States Department of Agriculture (USDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blood polyphenols and polyphenol metabolites | Blood polyphenols and metabolites will be measured by mass spectrometry at 0, 1, 2 and 4 hours post-meal consumption. | 0, 1, 2 and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Other | Urinary polyphenols and polyphenol metabolites | Urinary polyphenols and metabolites will be measured by mass spectrometry at 0 and 24 hours post-meal consumption. | 0 and 24 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Other | Oral and gut microbiome | The role of the oral and gut microbiome in efficacy of treatments at baseline and over time will be evaluated. | Pre-meal consumption at baseline and 1 month for each treatment period. | |
Primary | Vascular endothelial function | Vascular endothelial function will be assessed using reactive hyperemia index (EndoPAT) 0 and 4 hours post-meal consumption. | 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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. | 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | Blood triglycerides | Blood triglycerides will be measured by biochemical analysis at 0 and 1, 2, and 4 hours post-meal consumption. | 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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. | 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period | |
Secondary | Heart rate | Heart rate will be measured by an automatic sphygmomanometer and SphygmoCor at 0 and 1, 2, and 4 hours post-meal consumption. | 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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). | Pre-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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. | 0 and 1, 2, and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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. | 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period. | |
Secondary | 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. | 0 and 4 hours post-meal consumption at baseline and 1 month for each treatment period. |
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