Peanuts for Cardiometabolic, Brain, and Intestinal Health
In the US, 37.1 million adults have diabetes mellitus and 96 million have prediabetes. Type 2 diabetes mellitus (T2DM) accounts for 95% of the cases and results in many public health complications that increase economic burden and reduce productivity and quality of life. Eight out of 10 people with T2DM die from cardiovascular disease, while those with T2DM also face a 50% higher risk of developing dementia compared to healthy individuals. Also, studies indicate that intestinal health significantly influences the development of T2DM. Of note, the burden of T2DM is particularly pronounced in non-Hispanic Black and Hispanic populations compared to the non-Hispanic White population. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications. Plant-based foods, including peanuts and peanut products, have been increasingly recognized for their importance in the prevention and management of prediabetes and T2DM due to their unique nutritional profile, including their favorable fatty acid composition, fiber content, and bioactive compounds. While emerging evidence indicates that peanut improves cardiometabolic, cognitive and intestinal health, no studies have collectively and comprehensively evaluated the effects of peanut or peanut product consumption on the cardiometabolic, cognitive, and intestinal health of individuals with prediabetes or T2DM. Thus, this study aims to investigate whether adults with prediabetes consuming 43 g of peanut butter (1 snack cup) 3 x/week, 42 g of dry roasted peanuts (1/3 of a cup) 3x/week, or 56 g of peanut flour 1x/week for six months will have 1) reduced levels of serum HbA1c, fasting glucose (FBG), insulin, HOMA-IR (homeostatic model assessment of insulin resistance) and improved lipid profile, 2) reduced blood pressure, improved endothelial function, arterial stiffness and microvascular function, 3) Improved gut microbiota composition and reduced intestinal permeability, 4) improved cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) and brain health metrics as assessed by neuroimaging, and 5) reduced serum markers of oxidative stress and inflammation. The effectiveness of the intervention on the abovementioned outcomes among races including non-Hispanic Black (NHBA), non-Hispanic White (NHWA), non-Hispanic Asian (NHAA) and Hispanic (HA) adults will also be compared. Lastly, whether changes in cardiometabolic and cognitive outcomes are associated with changes in intestinal microbiota outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.
Phase
N/ASpan
135 weeksSponsor
Georgia State UniversityAtlanta, Georgia
Recruiting
Acutherapy to Prevent Aromatase Inhibitor-Associated Arthralgias in Non-Hispanic Black Postmenopausal Women with Early-Stage Breast Cancer
PRIMARY OBJECTIVE: I. To determine if initiation of in-person acupuncture or virtual acupressure sessions within 2 weeks of starting aromatase inhibitors (AI) will reduce the severity and incidence of AI-associated arthralgias (AIAA) among non-Hispanic Black postmenopausal women with stage I-III hormone receptor-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer at 6 months after starting adjuvant AI therapy. SECONDARY OBJECTIVES: I. To compare the efficacy of acupuncture to the efficacy of acupressure among the study population. II. To determine if acupuncture or acupressure will increase AI adherence (secondary endpoint) among the study population at 6 months after starting adjuvant AI therapy. III. To evaluate the acceptance, satisfaction, convenience, accessibility, and perceptions of in-person acupuncture and virtual acupressure. IV. To conduct 4 focus groups of 6-12 non-Hispanic Black women who receive 12 weeks of acupuncture or acupressure and collect and analyze qualitative data about barriers and facilitators to completing each intervention, transportation concerns, and ease or difficulty of completing each intervention. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) AI therapy. ARM II: Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy. ARM III: Patients receive SOC AI therapy. After completion of study intervention, patients are followed up for 12 months or until the initiation of new antineoplastic or investigational therapy, whichever occurs first.
Phase
N/ASpan
107 weeksSponsor
Emory UniversityAtlanta, Georgia
Recruiting
Heart Rate Variability and Inflammatory Bowel Disease
The goals of this study are to test the effectiveness of a virtually delivered, group-based coping skills treatment program incorporating heart rate variability biofeedback to target autonomic dysfunction in youth diagnosed with inflammatory bowel disease (IBD). Patients are youth ages 13-18 recruited through IBD clinics at Children's Healthcare of Atlanta. Enrollment will include up to 128 children with at least 1 parent. This study will last 7-months and will have 4 in person study visits, lasting about 1 hour each, as well as 6 virtual treatment sessions lasting about 45 minutes each. Study procedures will include surveys, chart/record review, blood sampling, and non-invasive assessments of psychophysiological functioning. Stool samples will be collected and stored. Informed consent and assent will be obtained in-person or remote signed.
Phase
N/ASpan
195 weeksSponsor
Emory UniversityAtlanta, Georgia
Recruiting
Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension
<Study purpose> The purpose of this single arm interventional study is to evaluate initial safety and device design concept of HyperQureTM, laparoscopic(extravascular) renal denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications including a diuretic The results of this study will be used to 1) prove the concept of complete ablation by Extravascular RDN and 2) develop a solid reference for a pivotal study <Background and Hypothesis> The HyperQureTM RDN System is developed to overcome the limitations of intravascular RDN using catheters; 1)incomplete renal denervation, 2) risk of endothelial damage due to heat transfer from inside blood vessels by intravascular access, and 3) access limitations due to vascular anatomy and vessel size. The HyperQureTM RDN System is accessed through the vascular adventitia where renal sympathetic nerves are mainly distributed by retroperitoneal laparoscopic(extravascular) approach . Since the energy is transmitted from outside of vessel by wrapping the blood vessel 360 degrees and the instrument is applicable to small vessels including branch and/or accessory vessels, it is expected that it will be possible to achieve more complete renal denervation, reduce the risk of endothelial damage, and resolve structural access limitations. <Study plan> Fifteen eligible adult men and women with resistant hypertension will be enrolled and will have Extravascular(laparoscopic) RDN under general anesthesia and will have 36month follow up with various BP evaluations(24hABP, Office BP and Home BP) and CTA/DUS imaging scan evaluations
Phase
N/ASpan
185 weeksSponsor
DeepQure Inc.Atlanta, Georgia
Recruiting
Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes
In the U.S., 35.3 million adults have type 2 diabetes mellitus (T2DM) and 96 million have prediabetes. Eight out of 10 people with T2DM die from cardiovascular disease. People with T2DM also have a 50% higher risk of developing dementia compared to healthy counterparts. Further, studies show that gut microbes play a major role in the development of T2DM. Prevention and treatment of T2DM focus on lifestyle changes including dietary modifications such as increased consumption of deep-colored fruits like berries. Blueberries are rich in fiber and phytochemicals and have several health benefits. We and others have shown that blueberry intake improves heart health in healthy men, hypertensive postmenopausal women, and men and women with metabolic syndrome. Yet, a comprehensive study in women with prediabetes that measures changes in cognitive performance and the underlying heart and gut health has not been conducted to date. Thus, the overall objective of this study is to investigate and bring forth evidence that blueberries improve gut, cardiometabolic, and cognitive function in women with prediabetes. Therefore, this pilot six-week randomized, placebo-controlled parallel-arm clinical trial aims to investigate whether daily consumption of 22 g of freeze-dried blueberry powder improves gut, cardiometabolic, and cognitive function in women with prediabetes. Investigators hypothesize that daily consumption of blueberries will improve cardiometabolic parameters, gut dysbiosis, and cognitive impairments in our study population. To test these hypotheses, the following specific aims are proposed. To investigate whether daily consumption of 22 g of freeze-dried blueberry powder: - Reduces levels of fasting blood glucose (FBG), insulin, and HOMA-IR (homeostatic model assessment of insulin resistance) and improves lipid profile in women with prediabetes. - Reduces blood pressure and improves endothelial function in women with prediabetes. - Improves cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]) in women with prediabetes. - Favorably modulates gut microbiota composition in women with prediabetes. - Improves serum markers of oxidative stress and inflammation in women with prediabetes. Additionally, whether changes in the gut microbiota are associated with changes in cardiometabolic and cognitive function outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters will be explored.
Phase
N/ASpan
37 weeksSponsor
Georgia State UniversityAtlanta, Georgia
Recruiting
Wild Blueberries for Gut, Brain, and Heart Health in Adults with High Blood Pressure
Hypertension (HTN), or high blood pressure (BP) is a major modifiable risk factor for heart disease, the leading cause of death worldwide. In the U.S., 121.5 million adults have high BP and only 25% have their BP under control. The 2022 Heart Disease and Stroke Statistics indicated that the incidence of high BP was higher among non-Hispanic Black (NHB) compared to non-Hispanic White (NHW) adults. Berries are rich in fiber and phytochemicals and have several health benefits. A 14-year follow-up of the Nurses' Health Study I and II and the Health Professional Follow-Up Study revealed a significant reduction in the risk of HTN (8%) among individuals in the highest quintile of anthocyanin intake compared to the lowest quintile. Blueberries are rich in fiber and phytochemicals that may be responsible for their health benefits. Studies have shown that daily blueberry consumption improves heart, cognitive, and intestinal health in different populations. Yet, a comprehensive study exploring and comparing the effectiveness of wild blueberries for cardiovascular, intestinal, and cognitive function parameters and their association in NHB and NHW adults with high BP has not been conducted to date. Thus, the overall objective of this timely study is to determine and compare the effectiveness of a freeze-dried wild blueberry intervention on cardiovascular and gut health in NHB and NHW adults with high BP and assess whether these health benefits are associated with improvements in memory and other important thinking abilities for productivity and quality of life. Therefore, this 8-week randomized, placebo-controlled parallel-arm clinical trial aims to assess whether daily consumption of 22 g of freeze-dried wild blueberry powder improves gut, cardiovascular, and cognitive function in NHB and NHW adults with elevated blood pressure and stage 1 hypertension. Investigators hypothesize that daily consumption of wild blueberries will improve cardiovascular parameters, gut dysbiosis, and cognitive function. To test these hypotheses, the following specific aims are proposed. To investigate whether daily consumption of 22 g of freeze-dried wild blueberry powder: - Reduces BP, improves endothelial function, arterial stiffness, and microcirculation. - Favorably modulates gut microbiota composition. - Improves cognitive function (verbal memory and executive functions [inhibition, working memory, cognitive flexibility]). - Improves serum markers of oxidative stress and inflammation. Additionally, investigators will also explore whether changes in the gut microbiota are associated with changes in cardiometabolic and cognitive function outcomes and whether changes in cardiometabolic outcomes are associated with changes in cognitive function parameters globally and within each race.
Phase
N/ASpan
68 weeksSponsor
Georgia State UniversityAtlanta, Georgia
Recruiting
Neonatal Platelet Transfusion Threshold Trial
Thrombocytopenia, defined as a platelet count <150 x 10^9/L, is a common neonatal problem that affects 22% to 35% of infants admitted to the neonatal intensive care unit. Platelets are important for primary hemostasis to prevent blood extravasation after vascular injury. Based on the role of platelets in hemostasis, prophylactic platelet transfusions are routinely administered to preterm infants with thrombocytopenia to prevent bleeding. The incidence of thrombocytopenia and administration of platelet transfusion are both inversely related to the gestational age at birth. Currently, there is uncertainty regarding the optimal platelet transfusion threshold, particularly among the most immature infants in the first week of life, which represents the period of highest bleeding risk. The NeoPlaTT trial was designed to address this pressing uncertainty in the highest risk population (<27 weeks GA). It will test whether a threshold of 20x10^9/L could be safely used after the first week of life, when the risk of serious bleeding is significantly lower, and reduce the need for platelet transfusion altogether. The results of this study have a potential to change clinical practice and improve outcomes in this vulnerable population, while also decreasing costs and resource utilization. This is a randomized trial with 1:1 allocation to parallel arms. Infants, inborn or outborn, who are admitted to participating NICUs, and who meet the inclusion and exclusion criteria, will be invited to enroll into the trial for platelet count monitoring. Only consented and enrolled infants meeting the additional platelet count trigger of < 50 x 10^9/L (up to 7 postnatal days) or <35 x 10^9/L (8 or more postnatal days) will be randomized. Randomization will be allowed to occur up to 36 6/7 weeks' PMA; subjects will be monitored through 40 0/7 weeks PMA. Approximately 30% of consented and enrolled infants are expected to meet the platelet count threshold for randomization.
Phase
N/ASpan
309 weeksSponsor
NICHD Neonatal Research NetworkAtlanta, Georgia
Recruiting
Healthy Volunteers
Modeling Ketosis-Prone Diabetes Remission Via Diverse Mechanisms of Glucotoxicity
Approximately half of newly diagnosed obese African Americans presenting with diabetic ketoacidosis (DKA) have clinical, metabolic and immunologic features of type 2 diabetes (T2D), also known as ketosis-prone diabetes (KPDM). Unlike patients with type 1 diabetes, with intensive insulin treatment, approximately 70% of patients with KPDM exhibit improved pancreatic β-cell function and insulin sensitivity to allow discontinuation of insulin therapy (indicating near-normoglycemia remission based on fasting blood glucose (FBG) < 130 mg/dl and HbA1c < 7% off insulin therapy during follow-up]). The clinical course of KPDM is variable, with the duration of remission ranging from 6 to 120 months. The origins of this variation in the ability to achieve remission and its duration are poorly understood. It has been observed that a 20-hour infusion of glucose reduces pancreatic beta (β)-cell function in a KPDM patient, and ketotic relapse is often preceded by hyperglycemia. The researchers thus hypothesized that the differences between conventional T2D and KPDM may be explained by the presence of a reversible glucotoxicity process, which operates on the timescale of days. The researchers developed a preliminary mathematical model describing the pathogenesis and remission of KPDM using such a process. The researchers showed that, by changing the rate of this hypothesized glucotoxicity process, this model can produce a variety of clinical courses, describing both conventional T2D and KPDM with varying rates and durations of remission. This study is a pilot study that will refine and validate this model using prospective clinical data with continuous glucose monitor (CGM) data from patients with KPDM. Patients will receive standard-of-care treatment for their diabetes as per their treating physician. Insulin therapy is the standard of care after an episode of DKA. Therefore, all participants will be discharged on insulin. A CGM will be placed on these participants at discharge from the hospital until insulin discontinuation. Since many of these patients insulin needs decrease after discharge from the hospital, the study team will utilize CGM glucose readings to adjust insulin doses.
Phase
4Span
49 weeksSponsor
Emory UniversityAtlanta, Georgia
Recruiting
Screening Strategies for People With a High Risk of Anal Cancer
Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals living with HIV. The study is important because the incidence of anal cancer is particularly high among certain groups; health disparity further contributes to this high risk among minorities. Findings will provide much-needed evidence for anal cancer screening strategies to reduce health disparities, improve screening outcomes, and decrease the incidence of anal cancer among high-risk minorities. The study population includes Black or Latinx, males - men having sex with men (MSM) only - and females with a known history of high-grade lower genital tract neoplasia. The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.
Phase
N/ASpan
150 weeksSponsor
Lisa FlowersAtlanta, Georgia
Recruiting
Healthy Volunteers
Safety of Anal Curcumin
This proposal suggests conducting a Phase I clinical trial using a 3 + 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions (aHSIL/AIN 2-3). Currently, there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV, aiming to reduce risks and complications associated with existing surgical and topical interventions. Curcumin, a compound derived from turmeric, is known for its anti-inflammatory and anti-infectious properties. While previous research has shown its anticancer effects in oral doses, its bioavailability is limited, and intra-anal administration has not been studied in humans. This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV. The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days, following the 3 + 3 dose escalation model. The trial will continue until the dose-limiting toxicity (DLT) level is reached, and participants report symptoms necessitating a dose reduction. To enhance future studies, the researchers will also evaluate patient and male partner acceptability through questionnaires. The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia.
Phase
1Span
46 weeksSponsor
Lisa FlowersAtlanta, Georgia
Recruiting
Healthy Volunteers