Vascular Reactivity Assessment by a Novel Diagnostic Device, AngioDefender™, compared to using Brachial Artery Ultrasound Imaging

Title:Vascular Reactivity Assessment by a Novel Diagnostic Device, AngioDefender™, compared to using Brachial Artery Ultrasound Imaging
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Everist Health
Funding Period:2015 to 2017
Study Design:Non-invasive, randomized, crossover, multicenter investigational device study, blinded (to results only)
Purpose:Cardiovascular diseases (CVDs) are disorders of the heart and blood vessels. Since symptoms often remain silent until a major health event occurs, it is important to detect and prevent CVDs at an early stage before symptoms occur.  One non-invasive means measures the function of endothelial cells that line the inside of blood vessels and help them dilate properly as blood flows through them.  Endothelial function is usually measured by a non-invasive ultrasound procedure that checks how well the brachial artery in the arm dilates as blood flows through it. This procedure works well, but requires highly skilled technicians and expensive equipment. This study compared a new automated machine (AngioDefenderTM) to brachial artery ultrasound imaging (BAUI) in measuring blood vessel function.  
Further Study Details: Other sites participating in this study included the Boston University School of Medicine, the Medical College of Wisconsin, and the University of Colorado.
Findings: Data obtained from these studies will be used to refine the automated technology.
Eligibility:Adults at least 18 years of age who might qualify to take part based on their overall health status, body mass index (BMI), arm circumference, blood pressure, blood cholesterol and glucose levels, absence of certain CVD clinical signs, absence of viral or bacterial infections, and ability to comply with study procedures.  

Changed at:11/30/2017 7:48 AMChanged by:Lisa Seaberg
Created at:3/1/2017 6:10 AMCreated by:Lisa Seaberg

The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes

Title:The Impact of Consumption of Eggs in the Context of Plant-Based Diets on Endothelial Function, Diet Quality, and Cardio-Metabolic Risk Factors in Adults at Risk for Type 2 Diabetes
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source:Egg Nutrition Center
Funding Period:2020-2021
Study Design:Randomized, single-blind, controlled, crossover trial
Purpose:People at risk for diabetes are more likely to develop type 2 diabetes, cardiovascular disease, stroke, and hypertension, and to have a higher risk of premature death. To help prevent these conditions, they’re often advised to consume plant-based diets and eat fewer foods from animal sources. However, if they exclude all foods from animal sources, they should plan carefully to get adequate nutrients that are more readily available from animal sources.Eggs provide high-quality protein and are rich in other nutrients that can be low or missing in exclusively plant-based diets. Although eggs are high in dietary cholesterol, recent research has shown that dietary cholesterol may be less likely to raise blood cholesterol levels than previously thought. Therefore, we conducted this study to compare the health effects and diet quality of a plant-based diet versus one combined with eggs.
Further Study Details:This study assessed the impact of including 2 eggs daily for 6 weeks in an otherwise exclusively plant-based diet, compared with a plant-based diet without eggs, on endothelial function (a measure of cardiovascular health), other cardio-metabolic risk factors, and dietary patterns in 35 adults who were at risk for type 2 diabetes.We enrolled 25 women and 10 men, with an average age of 61 years. With guidance from a dietitian, each person followed two variations of a plant-based diet (plant-based only, and plant-based plus 2 eggs per day) in randomly assigned order for 6 weeks each.
Findings:In these adults who were at risk for diabetes, adding 2 eggs daily to an otherwise plant-based diet for 6 weeks had no harmful effects on cardiovascular risk measures, fasting blood glucose, or insulin levels. Adding the eggs led to higher intakes of selenium and choline – two nutrients that are known to be depleted in exclusively plant-based diets. It also led to a small average increase in percent body fat, although body weight did not increase.Based on the results of this small study, eggs could potentially enhance the quality of plant-based diets consumed by adults at risk for type 2 diabetes without increasing their blood glucose or their risk for cardiovascular disease.  A larger study is needed to confirm our findings. More details on this study and its findings were published in the December 2021 issue of The Journal of Nutrition.
Eligibility:Men in the age range of 25 to 75 years, and postmenopausal women up to 75 years old who were not on hormone replacement therapy.  They were also non-smokers and had an increased risk for developing type 2 diabetes based on study criteria.
Evaluation:At different time points, we measured participants’ endothelial function, serum lipids, body composition, body weight, waist circumference, blood pressure, fasting insulin and fasting blood glucose, nutrient intake, and diet quality.

Changed at:12/21/2021 4:28 PMChanged by:
Created at:3/27/2020 2:58 PMCreated by:

Post-prandial Effects of High-polyphenolic Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes: A Randomized Controlled Crossover Trial

Title:Post-prandial Effects of High-polyphenolic Extra Virgin Olive Oil on Endothelial Function in Adults at Risk for Type 2 Diabetes: A Randomized Controlled Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source:Centers for Disease Control and Prevention (CDC); Cobram Estate Extra Virgin Olive Oil
Funding Period:2019-2020
Study Design:Randomized, Controlled, Crossover, Double-blind Trial
Purpose:This study compared the after-meal effects of two kinds of olive oil on measures of cardiovascular health in 20 adults (10 men, 10 women) at risk for type 2 diabetes. Diets rich in mono- and polyunsaturated fatty acids have been shown to improve cardiovascular health in people with or at risk for type 2 diabetes. Olive oils have a relatively high content of these fatty acids, with extra virgin olive oil having a significantly higher amount compared to refined olive oil.
Further Study Details:Participants were asked to fast 8 hours prior to testing.  Each participant consumed 2 smoothies (each on a different day) made with fruit and yogurt, and olive oil. Each smoothie was prepared with a different type of olive oil (either high-polyphenolic extra virgin olive oil or refined olive oil. Endothelial function and blood pressure were measured before and 2 hours after consumption of each smoothie.
Findings:High-polyphenolic extra virgin oil acutely enhanced endothelial function in the study cohort, whereas refined olive oil did not.  Blood pressure effects were not observed.
Eligibility:Non-smoking adults between the ages of 25-75 years who were willing to undergo screening for eligibility, visit the PRC three times for assessments, and consume a smoothie that included olive oil during two of these visits.
Evaluation:Endothelial function and blood pressure

Changed at:3/27/2020 3:52 PMChanged by:
Created at:3/27/2020 3:52 PMCreated by:

Phytoestrogen & Raloxifene EFfects on Endothelial Reactivity (PREFER): Double-blind, Placebo Controlled, Randomized Crossover Trial of Raloxifene versus Soy Phytoestrogens on Endothelial Reactivity in Healthy Post-Menopausal Women

Title:Phytoestrogen & Raloxifene EFfects on Endothelial Reactivity (PREFER): Double-blind, Placebo Controlled, Randomized Crossover Trial of Raloxifene versus Soy Phytoestrogens on Endothelial Reactivity in Healthy Post-Menopausal Women
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Eli Lilly & Co., Inc.
Funding Period:2/01-3/02
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:Many women take natural products and/or pharmaceuticals for the treatment of menopause-related conditions. This study was designed to compare the effects of raloxifene (a commonly prescribed medication for the prevention of osteoporosis) and soy phytoestrogens on endothelial function in healthy post-menopausal women. Participants were also surveyed regarding their preference for natural vs. synthetic therapy both before and after the study.
Further Study Details:A total of 25 women who participated in this study were assigned to three different treatments:raloxifene (60 mg),soy phytoestrogen (55 mg), andplaceboin random order each for six weeks. Following each treatment assignment, participants underwent BARS and lipid profile testing.
Findings:Neither of the active treatments (raloxifene or soy phytoestrogens) was found to enhance endothelial function (i.e. provide a protective effect on vascular functioning) in this pilot study. With regard to cholesterol findings, all three treatments (including placebo) were found to significantly lower total cholesterol and LDL from baseline. Further study is required to determine if particular subgroups of postmenopausal women would experience cardiovascular benefit from the use of synthetic or natural forms of estrogen.
Eligibility:Healthy, post-menopausal woman not taking hormone replacement therapy

Changed at:1/18/2011 5:13 AMChanged by:Judy Treu
Created at:8/31/2010 9:22 AMCreated by:Griffin Hospital

Egg Ingestion in Adults with Type 2 Diabetes: Effects on Glycemic Control, Anthropometry, Diet Quality and Cardiometabolic Status. A Randomized, Controlled Trial

Title:Egg Ingestion in Adults with Type 2 Diabetes: Effects on Glycemic Control, Anthropometry, Diet Quality and Cardiometabolic Status. A Randomized, Controlled Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Egg Nutrition Center
Funding Period:2013-2015
Study Design:Randomized controlled crossover trial
Purpose:To determine whether adults with diabetes could safely include eggs in their diets. For many years, healthcare providers have advised patients at risk for cardiovascular disease (CVD), including those with diabetes, to limit intake of eggs due to their cholesterol content. The prevailing view has been that dietary cholesterol could affect serum cholesterol, which could raise CVD risk.  However, results of early studies that seemed to link cholesterol intake and CVD risk were later questioned due to study design flaws. More recent studies had found no association between egg intake and CVD. The PRC’s own prior studies found no adverse effects of egg intake by healthy adults, adults at risk for CVD, or adults with coronary artery disease. Excluding eggs from the diets of diabetes patients could potentially lead them to eat other foods high in starch and sugar, which could increase CVD risk due to long-term effects of elevated blood glucose on blood vessels. 
Further Study Details:This study compared the effects of two ad libitum diets (one including 10-14 eggs per week for 12 weeks vs. one excluding eggs for 12 weeks) on diet quality and health outcomes in adults with diabetes.  Each participant was assigned to the intervention and control diets at different time points during the study. We expected to find that including eggs in the diet would lead to improved diet quality and health outcomes, compared to excluding eggs. 
Findings:Of the 34 enrolled participants, 32 completed the study. They were mostly male (59%) and white (76%), with a mean age of 64.5 years. Nearly all (97%) were taking diabetes medicines, 82% were on lipid-lowering medicines, and 71% were on blood pressure medicines. Including 2 daily eggs in the habitual diet of these adults: (1) did not lead to improved diet quality; (2) Had no significant effects on hemoglobin A1C levels compared to baseline or egg exclusion; (3) did not improve insulin resistance compared to egg exclusion; (4) did not improve systolic or diastolic blood pressure compared to egg exclusion, but led to a small significant improvement in systolic blood pressure compared to baseline; (5) significantly reduced body weight, waist circumference, BMI, visceral fat, and percent body fat, compared to egg exclusion. Excluding eggs for 12 weeks from the habitual diet significantly increased insulin resistance compared to baseline.  Our data suggest that short-term daily inclusion of eggs in the habitual diet of adults with Type 2 diabetes can lead to improvements in blood glucose control, systolic blood pressure, and body composition measures.
Eligibility:Adults diagnosed with Type 2 diabetes in the last 1 to 10 years, who were overweight and lacked any advanced complications from diabetes. This included men at least 35 years of age, and postmenopausal women who were not on hormone replacement therapy. 

Changed at:3/2/2017 9:09 AMChanged by:Lisa Seaberg
Created at:3/2/2017 9:09 AMCreated by:Lisa Seaberg

Effects of Walnuts on Endothelial Function in Overweight Adults with Visceral Obesity: A Randomized, Controlled, Crossover Trial

Title:Effects of Walnuts on Endothelial Function in Overweight Adults with Visceral Obesity: A Randomized, Controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:The California Walnut Commission
Funding Period:2009-2011
Study Design:Randomized controlled crossover trial
Purpose:This study explored the effects of daily walnut intake among overweight adults who had at least one risk factor for metabolic syndrome, a cluster of conditions (high blood pressure, high fasting glucose, high triglycerides, and/or low HDL cholesterol) that occur together and raise the risk of Type 2 diabetes and cardiovascular disease. Walnuts are a rich source of omega-3 fats, other healthful nutrients, and antioxidants, and have been shown to benefit cardiovascular health.
Further Study Details:Participants took part in an 8-week walnut phase and an 8-week control phase, with a 4-week washout period between phases. We randomly assigned half of the study group to start first with the control phase, and the other half to start first with the walnut phase.  The control phase consisted of following their typical eating habits. The walnut phase consisted of following their typical eating habits, with the exception of eating 2 ounces of walnuts per day and adjusting for the 350 extra daily calories from the walnuts to maintain a daily caloric intake consistent with the control phase. We compared the effects of both phases on endothelial function (ability of blood vessel walls to constrict and dilate properly), blood pressure, body weight, waist circumference, dietary intake, fasting glucose, and fasting lipids (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides). 
Findings:A total of 40 participants completed the study. During the walnut phase, endothelial function improved significantly from baseline compared to during the control phase. During the walnut phase, body weight and waist circumference remained stable, and there was a beneficial trend in reduction of systolic blood pressure. Dietary intake of polyunsaturated fats, omega-3 fats, omega-6 fats, and total fat increased significantly during the walnut phase while dietary intake of other nutrients remained stable. There were no significant changes in glucose or lipid levels during the walnut phase. Results provide evidence of a role for walnuts in protecting against diabetes and heart disease in at-risk individuals. 
Eligibility:Overweight men and women age 25 to 75 years who had not been diagnosed with diabetes or cardiovascular disease, but who had at least one risk factor for metabolic syndrome.

Changed at:3/2/2017 9:07 AMChanged by:Lisa Seaberg
Created at:3/2/2017 9:07 AMCreated by:Lisa Seaberg

Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial

Title:Effects of the FOS Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*;Complementary & Alternative Medicine;Diabetes / Insulin Resistance
Funding Source:Fos Biomedical, Inc.
Funding Period:2021-2022
Study Design:Randomized controlled double-blind crossover trial
Purpose:This study tested the effects of a phototherapy product on certain measures of health in people at risk for type 2 diabetes. According to recent research, certain wavelengths of light appear to activate an enzyme in the mitochondria of cells, which in turn appears to activate signaling pathways in the body.  A recent study of mice with diabetes showed that elevated activity of this enzyme led to reduced blood glucose levels and insulin resistance. 
Further Study Details:This study compared the effects of 12 weeks each of a phototherapy patch product vs. placebo patches on markers of cardio-metabolic risk and sleep quality.  The product used 2 small patches worn on the skin that, when activated by body heat, reflected low levels of infrared and visible light to stimulate the skin’s surface.  They did not contain any drugs or herbal compounds, and did not put any chemicals in the body. All tests and study products were provided free of charge.Outcome measures included hemoglobin A1C, insulin sensitivity, serum lipids, C-reactive protein, endothelial function (blood flow measured in the right arm using ultrasound), body composition, and sleep quality. For each of the two treatment periods, measures were assessed at baseline and 12 weeks.
Findings:Data analysis has not been completed.
Eligibility:Adults who met the following criteria:were older than 40 years of age (if women, they must be postmenopausal)were non-smokerswere overweighthad higher-than-normal blood glucose levels, but not diabeteswere willing to do the following over an 8-month period: visit the PRC at Griffin Hospital 5 times for clinical testswear 2 small patches on their abdomen each day for about 6 monthsreport their food and beverage intake on certain days 

Changed at:4/12/2023 4:42 PMChanged by:Christian Meagher
Created at:12/21/2021 12:41 PMCreated by:

Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men

Title:Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:NSA Corporation
Funding Period:2009-2010
Study Design:Randomized controlled trial
Purpose:Peripheral obesity is one of the hallmarks of the metabolic syndrome, which in turn is a risk factor for heart disease. Research suggests that antioxidants found in fruits and vegetables (such as beta carotene and vitamins C and E) may help blood vessels to dilate properly, thus potentially reducing the risk of heart disease. We wanted to explore whether fruits and vegetables, when concentrated into capsules, can help improve markers of cardiovascular risk – such as endothelial function testing – and markers of oxidative stress in overweight men with risk factors for metabolic syndrome after 8 weeks of daily Juice Plus supplementation.
Further Study Details:70 participants were randomly assigned to one of two groups. One group took Juice Plus capsules daily for 8 weeks, while the other took placebo capsules daily for 8 weeks. All participants were assessed for endothelial function and oxidative stress biomarkers before and after the treatment period. 
Findings:Juice Plus supplements did not improve markers for cardiovascular risk and oxidative stress in overweight men with risk factors for metabolic syndrome after 8 weeks of intake. Possible explanations for the lack of improvement in markers of cardiovascular risk and oxidative stress include the small sample size, an inadequate dose, and/or the short duration of the clinical trial.
Eligibility:Overweight men with increased waist circumference and risk factors for metabolic syndrome

Changed at:3/2/2017 9:00 AMChanged by:Lisa Seaberg
Created at:3/2/2017 9:00 AMCreated by:Lisa Seaberg

Effects of Egg Ingestion on Endothelial Function in Adults with Coronary Artery Disease: A Randomized, Controlled, Crossover Trial

Title:Effects of Egg Ingestion on Endothelial Function in Adults with Coronary Artery Disease: A Randomized, Controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Egg Nutrition Center
Funding Period:2010-2011
Study Design:Randomized Single-Blind Controlled Crossover Trial
Purpose:This study examined the health effects of eggs in people with coronary artery disease. Although restricting dietary cholesterol has been routinely recommended for patients with coronary disease, there has been a lack of consistent evidence that cholesterol in the diet affects cholesterol levels in the blood. Eggs contain cholesterol, but are an excellent source of protein and micronutrients, and are low in total fat and saturated fat. Our prior studies had shown that healthy adults and adults at risk for heart disease could consume eggs each day for 6 weeks without adverse effects on endothelial function (a measure of cardiac risk).
Further Study Details:The study compared the effects of 6 weeks of daily intake of 2 eggs vs. egg substitute vs. a high carbohydrate breakfast, on endothelial function or serum lipids (cholesterol, triglycerides, HLD, LDL, or VLDL) in adults with coronary heart disease.
Findings:In all, 32 adults (26 men and 6 women) with coronary heart disease, an average age 67 years, and average baseline body mass index of 31.2 completed the study. Endothelial function (the ability of blood vessels to constrict and dilate properly as blood flows through them) neither improved nor deteriorated significantly after eating 2 eggs or ½ cup egg substitute daily for 6 weeks when compared to a high carbohydrate breakfast. Body weight, body mass index, blood pressure, and serum lipids also did not improve or deteriorate significantly when compared to a high carbohydrate breakfast. Our findings, and the overall weight of evidence, argue against excluding eggs from heart-healthy diets, even among those with actual coronary disease. 
Eligibility:Men older than 35 years; post-menopausal women not taking hormone replacement therapy; non-smokers; coronary artery disease as defined by the presence of at least one coronary artery stenosis >50% or a documented history of myocardial infarction.

Changed at:3/2/2017 6:55 AMChanged by:Lisa Seaberg
Created at:1/18/2011 11:25 AMCreated by:Judy Treu

Dose and Response to Cocoa (DARC): A Randomized Double-Blind Controlled Trial

Title:Dose and Response to Cocoa (DARC): A Randomized Double-Blind Controlled Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:The Hershey Company
Funding Period:2012-2014
Study Design:Randomized, controlled, modified Latin square parallel design
Purpose:To compare the effects of two daily doses of cocoa consumption (five vs. 10 grams of cocoa powder) over an 8-week period on risk factors for cardiovascular disease in adults with stage one hypertension. Our own prior studies had shown that a 10-gram dose of cocoa powder could lead to improved blood vessel function in overweight adults. For this study, we wanted to learn whether the cardiovascular benefits of cocoa-containing products would vary when comparing this dose to a smaller dose (five grams) of cocoa powder, and whether this would affect blood pressure. Because chocolate is a popular dietary source of cocoa but is high in calories and often high in added sugar, we sought to determine a minimum cocoa dose that could provide heart-healthy benefits.
Further Study Details:The PRC recruited 60 men and women age 18-75 years who met the study criteria listed below.  Boston Medical Center recruited 60 patients who met the same criteria. 
Findings:When we analyzed the data for the entire group of participants, we found that daily consumption of either 5 or 10 grams of cocoa-containing products did not significantly improve blood pressure, endothelial function, arterial stiffness, lipid profile, glucose levels, or insulin resistance. When we analyzed the data on a sub-group basis (based on the types of blood pressure prescription medications that participants happened to be taking prior to, and during, the study), we found that the extent to which adding cocoa-containing products to their usual diets appeared to reduce their cardiovascular disease risk seemed to depend on which prescription medications that they were taking to control their blood pressure.
Eligibility:Men and women age 18-75 years with stage 1 hypertension (high blood pressure, with systolic pressure ranging from 140 to 159 and diastolic pressure ranging from 90 to 99) who were taking no more than one blood pressure medication, and who had a body mass index (BMI) of less than 35.

Changed at:3/2/2017 8:28 AMChanged by:Lisa Seaberg
Created at:3/2/2017 8:28 AMCreated by:Lisa Seaberg