Source: COLORADO STATE UNIVERSITY submitted to NRP
ACUTE AND CHRONIC EFFECTS OF RED BEETROOT JUICE CONSUMPTION ON HIGH-FAT MEAL-INDUCED CARDIOMETABOLIC DISTURBANCES
Sponsoring Institution
National Institute of Food and Agriculture
Project Status
COMPLETE
Funding Source
Reporting Frequency
Annual
Accession No.
1009727
Grant No.
(N/A)
Cumulative Award Amt.
(N/A)
Proposal No.
(N/A)
Multistate No.
(N/A)
Project Start Date
Jul 1, 2016
Project End Date
Jun 30, 2018
Grant Year
(N/A)
Program Code
[(N/A)]- (N/A)
Recipient Organization
COLORADO STATE UNIVERSITY
(N/A)
FORT COLLINS,CO 80523
Performing Department
Food Science & Human Nutrition
Non Technical Summary
Aging is the primary risk factor for cardiovascular disease largely due to adverse changes to the arteries. Aside from aging, numerous factors increase cardiovascular disease risk including diet and nutrition. Specifically, consumption of a high-fat diet is a contributing factor. Adverse responses to a high-fat meal may include arterial dysfunction, and increases in blood triglyceride levels, glucose, inflammation and free radicals. These responses are exacerbated in individuals who already suffer from excessive body weight and other cardiovascular disease risk factors such as hyperlipidemia and hyperglycemia. This can have significant adverse effects on cardiovascular health. As such, interventions that can prevent or reduce these responses to a high-fat diet in general, or the consumption of a high-fat meal, can play an important role in preserving cardiovascular health and reducing cardiovascular disease risk. Red beetroot juice is an excellent source of nutrients and phytochemicals. These compounds have been shown to have free radical quenching, anti-inflammatory, and cardiovascular-protective effects. Given the findings of previously conducted research in the broad area of red beetroot consumption and human health, it can be suggested that: 1) acute red beetroot consumption may prevent or reduce the disturbed 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 (e.g. improvements in vascular health). It is likely that the compounds in red beetroot juice work synergistically than indepdently. Accordingly, the overall goal of the proposed project is to investigate the efficacy of acute and chronic whole red beetroot juice consumption in reducing adverse responses to the consumption a high-fat meal and to gain insight into the reasons responsible for its effects.This work is important because the findings will inform the public on an area with important nutrition, food, and human health relevance. As such, individuals can use this information to make well-informed decisions about their diets and the inclusion of certain foods (e.g. functional foods) that can improve their nutritional status and thus their overall health and well-being.
Animal Health Component
45%
Research Effort Categories
Basic
45%
Applied
45%
Developmental
10%
Classification

Knowledge Area (KA)Subject of Investigation (SOI)Field of Science (FOS)Percent
70214591010100%
Goals / Objectives
Aging is the primary risk factor for CVD largely due to endothelial dysfunction which is involved in the development and progression of a number of cardiovascular disorders including atherosclerosis, hypertension, and arterial stiffness. Aside from aging, numerous factors increase CVD risk including diet and nutrition. Specifically, consumption of an atherogenic (e.g. high-fat) diet is a contributing factor. Postprandial cardiometabolic responses to a high-fat meal may include endothelial dysfunction (characterized by impaired endothelial-dependent vasodilation secondary to reduced nitric oxide [NO] bioavailability), dyslipidemia, hyperglycemia, inflammation and oxidative stress. These responses are exacerbated in individuals who already suffer from excessive body weight and other CVD risk factors such as hyperlipidemia and hyperglycemia. Considering that much of the day is spent in the postprandial state, this can have significant detrimental effects on cardiovascular health. As such, interventions that can prevent or mitigate these responses to a high-fat diet in general, or the consumption of a high-fat meal, can play an important role in preserving cardiovascular health and reducing CVD risk. 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 have been shown to have antioxidative, anti-inflammatory, and cardiovascular-protective effects. Given the findings of previously conducted research in the broad area of red beetroot consumption and human health, it can be suggested that: 1) acute red beetroot consumption may prevent or attenuate the disturbed 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 (e.g. chronic endothelial dysfunction). Because dietary nitrate is reduced to NO through the enterosalivary nitrate-nitrite-NO pathway independently of the vascular endothelium, much credit has been given to its nitrate content rather than the other bioactive compounds which likely work synergistically. Accordingly, the overall goal of the proposed project is to investigate the efficacy of acute and chronic whole red beetroot juice consumption in attenuating adverse postprandial responses to a high-fat meal and to gain insight into the underlying mechanisms responsible. Our central hypothesis is that acute and chronic consumption of whole beetroot juice with all of its bioactive components will be more effective than potassium nitrate, nitrate-free beetroot juice, and placebo in attenuating the negative effects of a high-fat, mixed macronutrient meal on endothelial and cardiometabolic function. This hypothesis will be tested using the following specific aims:Specific Aim 1: To determine the extent to which whole beetroot juice will attenuate acute endothelial dysfunction following consumption of a high-fat, mixed macronutrient meal. This aim will be assessed by measuring reactive hyperemia index using peripheral arterial tonometry.Specific Aim 2: To investigate the extent to which whole beetroot juice will prevent cardiometabolic disturbances following consumption of a high-fat, mixed macronutrient meal. This aim will be assessed by measuring postprandial brachial blood pressure, lipemia (blood triglyceride [TG] concentrations), glycemia (blood glucose and insulin concentrations). Specific Aim 3: To identify potential mechanisms by which whole beetroot juice exerts its effects on vascular endothelial function and cardiometabolic health. This aim will be assessed by measuring oral nitrate-reducing bacteria, plasma and salivary NO metabolites, plasma and urinary polyphenol metabolites, and blood biomarkers of oxidative stress (oxLDL) and inflammation (interleukin-6 [IL-6] and lipopolysaccharide [LPS]).
Project Methods
Study Overview: We propose a randomized, double-blind, placebo-controlled, 4-period, 4-week crossover pilot clinical trial consisting of 2 postprandial tests for each period. 15 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 assessments of medical history, dietary intake, and physical activity. 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 test meal. Endothelial function will be assessed at baseline (0 minutes) and 4 hours postprandially. Blood samples will be collected at baseline (0 minutes) and 1, 2, 4, and 6 hours postprandially. Urinary polyphenol metabolites will be assessed at baseline and 24-hours post intervention. Oral bacteria will be assessed at baseline and 4 weeks. At the third visit (Final), all assessments 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.Subjects: Postmenopausal women and men aged 40 to 65 years and overweight/obese (BMI 25-40 kg/m2) will be included. Individuals taking antihypertensive, lipid-lowering, or hormone replacement medications, diagnosed hypertension, CVD, diabetes, cancer, kidney, liver, or pancreatic disease, in a weight loss program, heavy smokers (≥ 20 cigarettes/d) and drinkers (> 12 drinks/wk), allergy to meals/treatments, or taking > 2 servings beetroot juice/wk will be excluded.Medical History and Blood Pressure: Information on conditions, diseases, menstrual history, medication, hormone, and nutritional supplement use will be obtained. Blood pressure will be measured in triplicate using an automatic device (Omron Healthcare).Anthropometrics, Diet, and Physical Activity Assessment: Height, weight, BMI, waist and hip circumferences will be measured using NHANES III methods. Three-day food records will be analyzed using NutritionistProTM diet analysis software (Axxya Systems). Physical activity patterns will be assessed using a seven-day physical activity recall.Blood, Urine, and Saliva Collection and Processing: Venous blood will be collected in vacutainers with appropriate anticoagulants, centrifuged, aliquoted, and kept at -80°C. Fasting midstream urine will be collected in sterile cups, aliquoted and kept at -80°C. Saliva will be collected, centrifuged, and supernatant kept at -80°C. Buccal swabs will be kept at -80°C.Test Meal: The test meal will contain 900 kcal and the macronutrient composition will be 50% fat (450 kcal, 50 g), 32% kcal from carbohydrates (288 kcal, 72 g), and 18% protein (162 kcal, 41 g). It will consist of a bagel, butter, cream cheese, jelly, boiled egg, and whole milk. Treatments and Compliance: Treatments: 1) 70 mL isocaloric placebo (PBO), 2) 70 mL PBO + 400 mg potassium nitrate (NIT); 70 mL beetroot juice concentrate (BRJ; contains 400 mg NIT), or 3) 70 mL nitrate-free BRJ (NF-BRF). All treatments will be provided by James White Drinks, Ltd. The PBO will be made isocaloric to the BRJ with similar degrees of sweetness, flavor and color. Compliance will be monitored examining unused treatments and a daily treatment log.Endothelial Function: Small finger artery endothelial-dependent vasodilation will be assessed using a non-invasive plethysmographic method (EndoPAT2000, Itamar Medical, Ltd) at baseline (0 minutes) and 240 min postprandially. Maximal changes in endothelial function occur 3-4 hours after a high-fat meal. After 10 min rest, the blood pressure cuff on the study arm will be inflated to 60 mmHg above systolic blood pressure for 5 min. The cuff will then be deflated in to induce reactive hyperemia and the signal from both PAT channels will be recorded by a computer. The reactive hyperemia index (RHI), an index of flow-mediated vasodilation, will be derived as the ratio of the average pulse wave amplitude during hyperemia (60 to 120 sec of post-occlusion period) to the average pulse wave amplitude during baseline in the occluded hand, divided by the same value in the control hand and then multiplied by a baseline correction factor. A RHI of 1.67 indicates endothelial dysfunction. Framingham RHI (F-RHI) will be calculated using a different post-occlusion hyperemia period (90 to 120 sec) without the baseline correction factor. Diastolic augmentation index (dAix) will be generated using the shape of the pulse wave recorded by the probes during baseline and normalized for a 75 bpm heart rate of (dAix@75).Biomarkers: Glucose (YSI 2300 Stat Plus™ Glucose Analyzer, Yellow Springs Instruments), insulin (chemiluminescent immunoassay, Beckman Access 2 Analyzer, Beckman Coulter), TG (enzymatic assay, Beckman AU480 Chemistry Analyzer, (Beckman Coulter), NO (colorimetry, Cayman Chemical), IL-6, and oxLDL will be measured (ELISA, R&D Systems, and Mercodia) at all 5 time points. LPS will be measured at 0, 60 and 120 min (Kinetic-QCL assay, Lonza).Oral Bacteria: Nitrate-reducing oral bacteria will be quantified from buccal swabs by qPCR using species-specific primers. Gene copy numbers will be quantified by comparing to standard curves of amplified DNA from pure cultures obtained from the American Type Culture Collection.Metabolomics: Targeted detection and quantification of flavonoids, phenolics, and carotenoids will be conducted using UPLC-MS. Briefly, carotenoids will be extracted from plasma and urine using hexane, and then dried under N2, resuspended in mobile phase, and separated by isocratic reverse phase chromatography. Flavonoids and phenolics will be extracted using 9% saline and separated by using a binary mobile phase gradient reverse phase chromatography. All compounds will be quantified by comparing to standard curves of commercial compounds.Statistical Analyses: Given the pilot nature of this study, a power calculation to determine sample size is difficult and instead have based the sample size of 15 participants on previous similarly designed intervention studies. Statistical analyses will be performed using SAS V9.4 (SAS Institute). Baseline values will be compared using paired sample t-tests. The effects of treatments on outcomes parameters will be evaluated using repeated measures ANOVA. Mean changes during the postprandial periods will be examined by interaction effects of condition and time. Post-hoc comparisons will be made as appropriate using Tukey's tests. Statistical significance will be based p < 0.05 using two-tailed tests. Correlations between variables will be evaluated.

Progress 07/01/16 to 06/30/18

Outputs
Target Audience:Study design and preliminary data have been presented at the Graduate Showcase at Colorado State University and the annual meeting of the American Society for Nutrition. Audiences of both venues include faculty, staff, students, registered dietitians, and industry representatives. Changes/Problems:One major change was made to the approach: The postprandial period of data collection following high-fat meal consumption was reduced from 6 hours to 4 hours to reduce subject burden and encourage subject enrollment and retention. Minor changes in biological sample endpoints measured occured due to feasability and cost of measurement. What opportunities for training and professional development has the project provided?This project has provided numerous graduate and undergraduate student opportunities for training in working with human subjects, safety and emergency procedures, data collection and management, data entry, biological sample processing, storage, and analysis, clinical trial management, and data interpretation. Students involved in the project have received mentorship and oversight from the Principal Investigator/Director on the project, Dr. Sarah A. Johnson, as well as the Co-Principal Investigators Dr. Tiffany Weir and Dr. Chris Melby. How have the results been disseminated to communities of interest?Study protocol information and preliminary results have been disseminated in oral and poster presentations, and have been disseminated through two Master of Science theses. Two manuscripts will be submitted for publication in early 2019. What do you plan to do during the next reporting period to accomplish the goals? Nothing Reported

Impacts
What was accomplished under these goals? A crossover design clinical trial involving 15 human subjects and 8 postprandial study visits was conducted. All data for the trial has been collected, entered, and analyzed, and the majority of the biololgical samples have been analyzed. Statistical analysis is currently underway and near completion. The results of this clinical trial will provide important information regarding the impact of high-fat meal consumption on postprandial atherogenic responses in an overweight/obese middle-aged and older population. Additionally, the results will determine: 1) the impact of red beetroot juice on postprandial responses when consumed with a high-fat meal, and when consumed for 1 month prior to consuming the second high-fat meal; 2) the contribution of different bioactive components within red beetroot juice to these responses, and 3) potential mechanisms leading to responses and non-responses.

Publications

  • Type: Theses/Dissertations Status: Published Year Published: 2018 Citation: Acute Red Beetroot Juice Consumption for Attenuating Postprandial Dysmetabolism in Overweight/Obese Middle-aged and Older Individuals.
  • Type: Journal Articles Status: Published Year Published: 2018 Citation: Johnson SA, Litwin NL, Van Ark H, Hartley SC, Fischer EK, Weir TL, Hildreth KL, Seals DR, Rao S, Melby CL. Red beetroot juice consumption for attenuation of high-fat meal-induced atherogenic responses in overweight/obese middle-aged and older adults: study protocol. Methods and Protocols, Current Developments in Nutrition, P15-015.
  • Type: Theses/Dissertations Status: Published Year Published: 2018 Citation: Effects of red beetroot juice consumption on protein biomarkers of vascular endothelial cell oxidative stress and antioxidant defense in overweight/obese middle-aged and older adults


Progress 10/01/16 to 09/30/17

Outputs
Target Audience: Nothing Reported Changes/Problems:One major change was made to the approach: The postprandial period of data collection following high-fat meal consumption was reduced from 6 hours to 4 hours to reduce subject burden and encourage subject enrollment and retention. What opportunities for training and professional development has the project provided?This project has provided numerous graduate and undergraduate student opportunities for training in working with human subjects, safety and emergency procedures, data collection and management, data entry, biological sample processing, storage, and analysis, and clinical trial management. Students involved in the project have received mentorship and oversight from the Principal Investigator/Director on the project, Dr. Sarah A. Johnson. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, we plan to continue data collection on the currently enrolled subjects. We also plan to continue analyzing biological samples and data entry in preparation for statistical analysis and result interpretation, and completion of the clinical trial.

Impacts
What was accomplished under these goals? Since project initiation, 240 individuals have been screened over the phone and/or in person for eligibility. Of these 240 individuals, 24 individuals have been enrolled and randomized to intervention order. 8 individuals have completed the entire study, 8 individuals dropped from the study, and 7 individuals are currently enrolled in the study. Final data collection is expected to be achieved by September 2018. Data collected on all enrolled and randomized subjects include reactive hyperemia index (endothelial function), other measures of vascular function and health including blood pressure and pulse wave analysis. Biological samples (blood, endothelial cells and peripheral blood mononuclear cells, urine, saliva, oral swabs, stool samples) have been collected for future analysis of biomarkers related to cardiometabolic health, microbiota, polyphenol metabolism, inflammation, and oxidative stress. Preliminary analysis of select biological samples are currently underway, but no statistical analysis has been performed and therefore no results are available at this time. Data entry is being completed using RedCAP for all available data.

Publications


    Progress 07/01/16 to 09/30/16

    Outputs
    Target Audience: Nothing Reported Changes/Problems: Nothing Reported What opportunities for training and professional development has the project provided?As previously stated, significant efforts were made during this time to submit an application to the Colorado State University IRB. This provided an opportunity for student training on conducting clinical research and submitting an IRB application. In addition, study investigators and students were trained in areas specific to this study including laboratory safety, working with human subjects, and in biological sample collection, processing, and analysis. How have the results been disseminated to communities of interest? Nothing Reported What do you plan to do during the next reporting period to accomplish the goals?During the next reporting period, our plan is to register the trial on ClinicalTrials.gov to ensure clinical study transparency and publication of the study findings in a high-quality and high-impact peer-reviewed journal, purchase treatments to be used for the study intervention, initiate subject recruitment, subject screening, and subject enrollment in the study, and to begin testing on subjects in an effort to collect data. These steps are essential to completion of the major goals of this project.

    Impacts
    What was accomplished under these goals? The effective start date for this project was 07/01/2016. Between 07/01/2016 and 09/30/2016, significant efforts were made to submit an application to the institutional review board (IRB) at Colorado State University. An application was submitted and approved by the IRB. In addition, significant efforts were made to prepare for the initiation of the study which included training of study investigators and students, development of detailed study protocols and procedures, and purchasing of study supplies. These essential first steps were completed to facilitate initiation of the study such that the major goals of the project can be completed.

    Publications