Tag: Cardiovascular Health / Endothelial Function*

Effects of Egg Ingestion on Endothelial Function in Hyperlipidemic Adults: A Randomized, Controlled, Crossover Trial

Title:Effects of Egg Ingestion on Endothelial Function in Hyperlipidemic Adults: A Randomized, Controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Egg Nutrition Center of the USDA
Funding Period:12/03 – 1/05
Study Design:Randomized, Single-Blind Crossover Study
Purpose:To assess the effects of daily egg consumption on endothelial function among adults with untreated hyperlipidemia (high cholesterol).
Further Study Details:A total of 40 adults participated in this study. During the acute phase, participants underwent endothelial function (BARS) and cholesterol testing following two separate study breakfasts (eggs, and a high-fat sausage patty with cheese). Participants were then assigned to two daily treatment breakfasts, in random order, each for a period of 6 weeks:2 eggs, and1 serving of Egg Beaters.Egg Beaters was used as a comparison since it is similar to eggs in most ways with the exception of the amount of dietary cholesterol. At the end of each 6-week treatment period, participants underwent endothelial function (BARS) and cholesterol testing.
Findings:Daily egg ingestion for 6 weeks lowered cholesterol and triglyceride levels in adults with high cholesterol. Endothelial function, a strong predictor of cardiac risk, was unaffected by sustained egg ingestion. Egg Beaters also lowered cholesterol and triglyceride levels. However, ingestion of Egg Beaters led to a decrease in LDL cholesterol levels and improved endothelial function as compared to egg consumption over a 6 week period. While the mechanism of action is unexplained, the nutrient profile of eggs may have conferred some benefit to ameliorate cardiac risk in study participants with elevated cholesterol levels at baseline. The beneficial effects of Egg Beaters may be attributed to a lack of cholesterol and fat in the product. Egg ingestion does not appear to affect endothelial function adversely in hyperlipidemic individuals.
Eligibility:Adult men and women with high cholesterol (total cholesterol of >240 mg/dl and/or LDL cholesterol of >160mg/dl, and/or a total cholesterol to HDL ratio of >5.7) not currently taking lipid lowering medication.
Changed at:1/17/2011 11:08 AMChanged by:Judy Treu
Created at:8/31/2010 9:12 AMCreated by:Griffin Hospital

Effects of Juice Plus+® Supplementation on Endothelial Function in Insulin Resistant Adults: A Randomized, Controlled, Crossover Trial

Title:Effects of Juice Plus+® Supplementation on Endothelial Function in Insulin Resistant Adults: A Randomized, Controlled, Crossover Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:NSA Corporation
Funding Period:5/04-6/08
Study Design:Randomized, Double-Blind, Placebo-Controlled Crossover Trial
Purpose:To determine the effects of supplementation of Juice Plus+® (fruit/vegetable juice concentrates) on heart health among insulin-resistant adults.
Further Study Details:A total of 48 men and women participated in this study. The study 4 examined the effects of sustained ingestion (daily for 8 weeks) of two different treatment assignments: (Juice Plus+® Orchard/Garden/Vineyard Blends and Orchard/Garden Blends) as compared to placebo on endothelial function.
Findings:Juice Plus+® Orchard/Garden/Vineyard Blends and Orchard/Garden Blends treatments improved endothelial function, but the results were not statistically significant. The lack of statistical significance could be due to insufficient dose, short duration of intervention, or the small sample size of this study. The Orchard/Garden Blends treatment seemed to improve HDL cholesterol level. Neither Juice Plus+® treatment had an effect on body weight.
Eligibility:Healthy adult men and women with insulin resistance.
Changed at:1/17/2011 10:59 AMChanged by:Judy Treu
Created at:8/31/2010 9:10 AMCreated by:Griffin Hospital

Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial

Title:Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:NSA Corporation
Funding Period:2009-2010
Study Design:Randomized, Double-Blind, Placebo-Controlled Trial
Purpose:To explore whether the benefits of fruits and vegetables, when concentrated into capsules, can help improve endothelial function (the ability of blood vessels to dilate properly) and other measures of heart health in overweight men. Fruits and vegetables are high in antioxidants such as beta carotene and vitamins C and E, which are thought to help blood vessels dilate properly.
Further Study Details:This study examined the effects of 8 weeks of daily ingestion of Juice Plus+® capsules (fruit/vegetable juice concentrates) on endothelial function and biomarkers of oxidative stress in overweight men. The PRC randomly assigned 70 participants to receive one of two treatments: (1) Juice Plus+® containing Orchard, Garden and Vineyard blends or (2) placebo. Participants received their assigned treatment twice daily for 8 weeks, and were instructed to take their treatment at approximately the same time each day. They were evaluated at 2 time points: at baseline, and upon completion of the sustained treatment assignment.
Findings:Findings will be available in early 2011.
Eligibility:Healthy men aged 25 to 75 years; overweight (BMI at least 25; waist circumference at least 102 cm); non-smoker; no history of diabetes mellitus, cardiovascular disease, eating disorder, substance abuse, or endothelial dysfunction with a high-fat meal
Changed at:1/18/2011 5:06 AMChanged by:Judy Treu
Created at:8/31/2010 9:05 AMCreated by:Griffin Hospital

Effects of Acute and Sustained Ingestion of Cocoa on Endothelial Function in Adults with BMI between 25-35 kg/m2: A Randomized, Single Blind, Placebo Controlled, Trial

Title:Effects of Acute and Sustained Ingestion of Cocoa on Endothelial Function in Adults with BMI between 25-35 kg/m2: A Randomized, Single Blind, Placebo Controlled, Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Hershey Foods Corporation
Funding Period:2005-2007
Study Design:Randomized, Placebo-Controlled Cross-Over Trial
Purpose:To examine the acute effects of sugar-free, liquid, cocoa and dark, solid chocolate ingestion on endothelial function and associated markers of cardiovascular health among overweight adults. The study also assessed the sustained effect of liquid cocoa ingestion on vascular health. An initial pilot study was conducted to evaluate the dose response effects of sugar-free liquid cocoa ingestion.
Further Study Details:Phase 1 (acute)45 participants were randomly assigned to receive one of the two possible sequences of 74 g solid dark chocolate and 74 g placebo.In Phase 2 (sustained)Participants were randomized to the following liquid treatment assignments: 22 g sugar-free cocoa, 22 g sugared cocoa and 22 g placebo for a period of 6 weeks. Participants underwent endothelial function testing after each treatment assignment to determine the short and long term effect on endothelial function. The primary outcome measure was endothelial function; secondary outcome measures included BMI, waist circumference, C-reactive protein, blood pressure, serum glucose, and lipids.
Findings:The acute ingestion of both solid dark chocolate and liquid cocoa improved endothelial function and lowered blood pressure in overweight adults. Endothelial function was significantly lower after dark chocolate consumption compared to placebo. The same results occurred with the sugar-free liquid cocoa; cocoa ingested for six weeks improved endothelial function from baseline as compared to placebo. Other markers of heart health (blood pressure, C-reactive protein, LDL oxidation, endothelin and lipid hydro-peroxide) did not change from baseline as compared to placebo following sugar-free or sugared cocoa assignment. Based on the results of all phases of our study, it appears that solid dark chocolate and liquid cocoa significantly improve endothelial (blood vessel) function. Sugar-free cocoa seems to provide the greatest benefit, but moderate consumption of any kind of dark chocolate should promote cardiovascular health.
Eligibility:Non-smoking adults ages 30-75 years with a Body Mass Index (BMI) between 25-35 kg/m2, and a waist circumference greater than 88 cm in women and 102 cm in men.
Changed at:1/17/2011 10:58 AMChanged by:Judy Treu
Created at:8/30/2010 11:48 AMCreated by:Griffin Hospital

Effects of Fruit and Nut KIND Bars on Endothelial Function in Overweight Adults

Title:Effects of Fruit and Nut KIND Bars on Endothelial Function in Overweight Adults
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:Peace Works Holdings, LLC
Funding Period:2008-2009
Study Design:Pilot Study
Purpose:To determine the effects of a diet enriched with KIND Fruit and Nut snack bars twice daily for an 8 week period on endothelial function/heart health and related risks in overweight adults with one additional risk factor for insulin resistance.
Further Study Details:During Phase 1 of this study, 19 men and women consumed two KIND Fruit and Nut snack bars daily for 8 weeks. Participants underwent endothelial testing (BARS – see description above) and laboratory testing before and after the treatment period to determine the effect that KIND Fruit and Nut bars have on heart health and related markers (i.e., blood pressure, cholesterol, etc). Phase 2 follows a larger sample size of 100 more participants (50 in the intervention group and 50 in the control group) to examine the effects of eating 2 KIND bars per day for 8 weeks on weight and blood pressure.
Findings:The results of the pilot study (Phase 1) did not reflect a statistically significant change in endothelial function (the primary outcome of interest). However, we did observe downward trends in weight and blood pressure after 8 weeks of KIND bar consumption. Since the sample size of 19 adults may have been too small to show statistical significance, a follow-up study is underway to with 100 additional participants.
Eligibility:Adults with a body-mass index greater than 25.0, and one or more additional risk factors for insulin resistance: abdominal obesity determined by waist circumference >102 cm (>40 in) in men or >88 cm (>35 in) in women; elevated triglyceride level; HDL-C <40 mg/dL in men or <50 mg/dL in women; elevated blood pressure; and/or fasting glucose ≥100 mg/dL.
Changed at:1/17/2011 10:57 AMChanged by:Judy Treu
Created at:8/30/2010 11:45 AMCreated by:Griffin Hospital

Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross Over Trial

Title:Effects of Walnut Consumption on Endothelial Function in Type 2 Diabetes: A Randomized, Controlled, Cross–Over Trial
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:California Walnut Commission
Funding Period:2007-2009
Study Design:Randomized, Controlled, Cross–Over Trial
Purpose:To determine if consumption of walnuts improves endothelial function and lipid markers in people with Type 2 diabetes.
Further Study Details:Study participants were required to maintain their normal/routine (ad libitum) diet while participating in this study. Their dietary patterns were assessed upon enrollment in the study to establish baseline values. The study consisted of two phases and participants were randomly assigned to each of the two treatment assignments:supplementation of the diet with 1.5 ounces or 42 grams of walnuts, ora diet without walnut supplementation for 8 weeks. Participants were then switched to the other treatment assignment for the second 8 week period.
Findings:When people with Type 2 diabetes followed the walnut-enriched diet on a daily basis for 8 weeks, they had a statistically significant improvement in endothelial function compared to when they followed their usual diets. They also had a trend toward lower levels of total and LDL cholesterol, but this was not statistically significant. No significant changes were found in body mass index, weight, waist circumference, triglycerides, HDL cholesterol, or fasting plasma glucose.
Eligibility:Adults between the ages of 35 and 65 who had been diagnosed with type 2 diabetes
Changed at:1/17/2011 10:55 AMChanged by:Judy Treu
Created at:8/30/2010 10:25 AMCreated by:Griffin Hospital

Effects of Walnuts on Endothelial Function in Overweight Adults with at Least One Factor of Metabolic Syndrome

Title:Effects of Walnuts on Endothelial Function in Overweight Adults with at Least One Factor of Metabolic Syndrome
Status:Completed
Topic:Cardiovascular Health / Endothelial Function*
Funding Source:California Walnut Commission
Funding Period:2010-2011
Study Design:Randomized, Controlled, Cross–Over Trial
Purpose:To determine if consumption of walnuts improves endothelial function, cholesterol, and triglycerides in overweight adults with at least one indicator of metabolic syndrome (a cluster of conditions that occur together and raise the risk of cardiovascular disease and Type 2 diabetes)
Further Study Details:Walnuts are a nutrient-dense whole food source of antioxidants and an essential omega-3 fatty acid, and are thought to be beneficial to cardiovascular health. This study examined the effects of daily walnut consumption (2 ounces or 56 grams per day for 8 weeks) among 46 overweight non-diabetic adults (18 men and 28 women) men and women who had at least one risk factor for metabolic syndrome, but who had not been diagnosed with cardiovascular disease. Specifically, it examined whether consuming walnuts had any effect on endothelial function, blood pressure, fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, body weight, or waist circumference. Study participants were asked to practice their usual eating habits during an 8-week control phase. They were instructed during another 8-week period to continue their usual eating habits, with one exception – eating 2 ounces of walnuts per day while adjusting for the extra calories from the walnuts so their daily calorie intake would be consistent with the control phase. There was a 4-week washout period between the two dietary phases.*Cardiovascular health is a research priority at the Yale-Griffin Prevention Research Center. We have a vascular lab where we conduct studies of endothelial function – a measure of blood vessel behavior. Blood flow and blood vessel reactivity are indicators of heart health. When blood vessels dilate (expand) or constrict (shrink) properly, endothelial function is considered to be normal. If they constrict when they should dilate, endothelial function is abnormal. Impaired (or abnormal) endothelial function is associated with an increased risk of heart disease. We measure endothelial functioning with the use of ultrasound imaging of the brachial artery in the arm (called Brachial Artery Reactivity Scan or BARS) – a simple and painless procedure which provides a picture of the blood vessels.
Findings:Study participants had an average age of 57 years. Of the 46 enrolled, 40 completed the study. After 8 eight weeks of daily walnut intake, participants’ endothelial function improved significantly compared to the control phase, and their body weight and waist circumference remained stable. They experienced a trend in reduction of systolic blood pressure (the upper number in a blood pressure reading); however, that did not quite reach statistical significance. Participants’ mean measures of fasting glucose, total cholesterol, LDL, HDL and triglycerides while eating walnuts did not differ significantly from baseline as compared to while on the control diet. The study results provide evidence that walnuts can play a role in protecting against diabetes and heart disease in at-risk individuals.
Eligibility:Overweight men and women age 30 to 75 years who were non-smokers with a body mass index (BMI) greater than 25, and who had at least one risk factor for metabolic syndrome (high blood pressure, high fasting serum glucose, high fasting serum triglycerides, and/or low fasting HDL cholesterol).
Changed at:11/28/2018 7:09 AMChanged by:Lisa Seaberg
Created at:8/30/2010 10:06 AMCreated by:Griffin Hospital

Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Endothelial Function, Cardio-Metabolic Risk Factors and Diet Quality

Title:Effects of Daily Inclusion of Eggs in a Heart-Healthful Dietary Pattern on Endothelial Function, Cardio-Metabolic Risk Factors and Diet Quality
Status:Current
Topic:Cardiovascular Health / Endothelial Function*;Diabetes / Insulin Resistance;Nutrition / Diet
Funding Source:The Egg Nutrition Center
Funding Period:July 2022 – December 2023
Study Design:Randomized controlled trial with a crossover design. All participants will be assigned to both an intervention and a control phase. The sequence of the phases will be randomly assigned.
Purpose:This study will examine the effects of including eggs in the context of the Dietary Approach to Stop Hypertension (DASH) diet.The DASH diet features vegetables, fruits, whole grains, low-fat dairy products, fish, poultry, beans, nuts, seeds, and vegetable oils. It includes eggs, but limits egg yolks to 4 per week due to their cholesterol content, and the long-standing belief that foods high in dietary cholesterol raise blood cholesterol level. Yet recent studies haven’t supported a link between dietary and blood cholesterol levels and cardiovascular risk.Because eggs are rich in protein, vitamins, and minerals, and contribute to satiety, it is important to study their consumption in the context of health-promoting diets. 
Further Study Details:This study will examine the effects of a DASH diet with and without eggs on cardio-metabolic risk measures and diet quality when consumed by 45 overweight adults with high blood cholesterol.  Participants will be randomly assigned to Group A or B. Both groups will receive dietary guidance from the study dietitian.During an initial 4-week run-in period, both groups will consume a DASH diet without eggs.After the first 4 weeks:Group A will consume a DASH diet plus 2 eggs daily for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet without eggs for 8 weeks (Phase 2).Group B will consume a DASH diet without eggs for 8 weeks (Phase 1), then a DASH diet without eggs during an 8-week washout, then a DASH diet plus 2 eggs daily for 8-weeks (Phase 2). 
Eligibility:Inclusion criteria:Men greater than 18 years of agePost-menopausal women not on hormone replacement therapyNon-smokersOverweight or obeseTotal cholesterol of 240-300 mg/dl and /or LDL cholesterol of 130-190 mg/dl, and/or a total cholesterol to HDL ratio of >5.7
Evaluation:Assessments will be done at the start and end of each phase. Each of the 4 study assessments will include these measures: 1. Ultrasound of the brachial artery in the right arm to assess blood flow (endothelial function) 2. Review of 3-day diet intake, medications, and physical activity 3. Blood pressure 4. Height, weight, body composition and waist circumference 5. Blood cholesterol, glucose, and insulin
Changed at:4/12/2023 4:14 PMChanged by:Christian Meagher
Created at:4/12/2023 4:14 PMCreated by:Christian Meagher

CORE RESEARCH PROJECT: Improving Health in Low Income Communities – Virtual Delivery of a Diabetes Prevention Program Facilitated by Community Care Coordination

Title:CORE RESEARCH PROJECT: Improving Health in Low Income Communities – Virtual Delivery of a Diabetes Prevention Program Facilitated by Community Care Coordination
Status:Current
Topic:Community;Diabetes / Insulin Resistance;Nutrition / Diet;Physical Activity
Funding Source:Centers for Disease Control and Prevention (CDC)
Funding Period:2019-2024
Study Design:Implementation Science Research
Purpose:The risk of diabetes is higher among low-income populations. The progression from pre-diabetes to type 2 diabetes can often be prevented through lifestyle interventions. The Diabetes Prevention Program (DPP) is among the best-studied lifestyle interventions. However, people with low incomes often face barriers to engaging in the DPP when offered in traditional settings. Providing digital online access to the DPP – combined with personally tailored guidance and care coordination – might improve participation, engagement, and outcomes.
Further Study Details:This study will assess the feasibility and health impacts (behavioral and cardio-metabolic outcomes) of implementing a virtually-delivered Diabetes Prevention Program (vDPP) – facilitated by community health workers or hospital-based community nurses –among low-income adults at risk for type 2 diabetes.  It will identify and address barriers to participating in evidence-based lifestyle programs.  The study will take place in New Haven and the Lower Naugatuck Valley of Connecticut.Specific Aims:Conduct formative research (focus groups, interviews with key stakeholders, and a small pilot study) with community partners to assess community, systemic, technological, and structural level barriers to implementing a v-DPP.In collaboration with community partners, use strategies identified in Aim 1 to maximize impact of the v-DPP in target communities, as evidenced by measures of Reach, Effectiveness, Adoption, Implementation, and Maintenance; and assess factors influencing RE-AIM outcomes, such as social determinants of health, demographic variables, and self-efficacy.Demonstrate improvements in diet quality, physical activity, body weight, and blood pressure, in low-income adults at risk for type 2 diabetes who participate in a v-DPP facilitated by community-based care coordination.Collaborate with community partners to develop and implement a strategic approach to sustain the v-DPP benefits through community-based care coordination in the study communities; and then disseminate the model to other communities.
Eligibility:Adult residents of New Haven and the Lower Naugatuck Valley of CT who are eligible for Medicaid and at risk for type 2 diabetes.
Evaluation:See “Specific Aims” above
Changed at:12/21/2021 12:48 PMChanged by:
Created at:3/27/2020 2:52 PMCreated by: