Clinical Research Directory

IMPACT: Immune and Musculoskeletal Physiological Adaptations to Combined Exercise Training & Nutrition

The purpose of this study is to determine whether 12 weeks of exercise training combined with dairy consumption influences inflammation and immune responses in adults with overweight, compared to exercise training alone.

Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Randomized Controlled Parallel-Group Clinical Trial

The goal of this clinical trial is to evaluate whether daily supplementation with cold-pressed pecan nut oil can reduce inflammation in adults with overweight. The main questions it aims to answer are: Does pecan nut oil supplementation reduce inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α)? Does pecan nut oil supplementation improve biochemical parameters such as fasting blood glucose and lipid profile? Researchers will compare an experimental group receiving pecan nut oil to a control group with no intervention to determine its effect on inflammation and metabolic parameters. Participants will: Consume 30 g/day of cold-pressed pecan nut oil under fasting conditions for 8 weeks (experimental group) Maintain their usual diet and physical activity throughout the study Attend two evaluation visits (baseline and Day 60) for blood sample collection and anthropometric measurements Provide dietary information using a 24-hour dietary recall

Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial

Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.

To Test the Effectiveness and Implementation Approach of a 3-month PILI Pasifika Program Lifestyle Program With Components of Social Determinants of Health Activities in Real-world Settings (Clinical and Non-clinical Settings) Across 3 Years

In this study, the investigators are testing the effectiveness and implementation of the Community Health Workers (CHW)-delivered PILI Pasifika Program (PPP) Standard Facilitation or Enhanced Facilitation across 3 regions, the U.S. Affiliated Pacific Islands (USAPI), the continental U.S., and Hawai'i, among 600 Native Hawaiian and Pacific Islander (NHPI) participants in two settings, (clinical and non-clinical) over a 3-year period. The PPP is a 3-month lifestyle intervention that includes a Social Determinants of Health (SDOH) component and was NHPI-adapted from the Diabetes Prevention Program's Lifestyle Program, renamed to the PILI Lifestyle Program (PLP), which demonstrated effectiveness in improving weight, blood pressure, physical activity, and diet among NHPIs. The PPP consists of 8 lifestyle lessons and 4 SDOH activities delivered over a 3-month period. The investigators will conduct an effectiveness-implementation hybrid type 2 trial using a 3 (Region) x 2 (Setting) x 2 (Delivery Mode) factorial design. The long-term objective of this study is threefold: 1. To conduct an effectiveness-implementation hybrid 2 trial to test the effects of the PPP implementation strategies across different settings and modes of delivery among 600 NHPIs at risk for cardiometabolic-related conditions using an NHPI-approved and adapted evaluation framework. The investigators will also assess and compare the cost-effectiveness of the CHW-delivered PPP-Standard Facilitation and PPP-Enhanced Facilitation to support long-term sustainability. 2. To conduct a longitudinal Social Determinants of Health (SDOH) survey embedded within the trial to examine the reliability and validity of indices from 5 adapted SDOH instruments and to assess the associations between SDOH variables and chronic disease risk among NHPIs. 3. To implement and evaluate the contextually-based CHW training program on PPP delivery.

SSRD and Overweight

The investigators have previously found that a starch- and sucrosereduced diet (SSRD) has led decreased gastrointestinal symptoms in patients with irritabel bowel syndrome (IBS). At the same time, investigators found that the weight was reduced and the nutrient intake was improved with a more favorable metabolic profile. However, it is a challenge to change lifestyle, and most persons fail to keep on with an improved diet for a long time. Investigators therefore now want to conduct a clinical trial with SSRD in overweight/obesity for 3 months. Persons with a BMI \>25 kg/m2 will be included. To examine whether a feedback about improved metabolic profile enhances the compliance, participants will be randomized to be informed or not about the metabolic profile after the 6-week visit. Investigator´s hypothesis is that information about the improvement in the metabolic profile should increase the motivation and compliance in the patients, and thereby render better effects.

Physical Acvitiy in Pregnancy

The goal of this observational study is to learn how a physically active lifestyle during pregnancy affects placental development and function. The main question it aims to answer is: Does regular physical activity during pregnancy improve placental function and support healthy fetal growth? Pregnant participants will provide biological samples and health information during pregnancy and at delivery. The study will use these samples to examine how activity levels relate to placental energy production and overall health.

Effect of Low Volume Sprint Interval Training on Cardiorespiratory Fitness

Low levels of physical activity (PA) are related to poor health and greater risk of premature death in adults. Lack of time is cited as a primary barrier to partaking in PA. In the last 20 years, a lot of attention has been directed towards the efficacy of high intensity interval training (HIIT), which consists of brief, intense bursts of PA separated by recovery. One primary benefit of HIIT is a sizable increase in cardiorespiratory fitness (CRF), which enables adults to exercise better and reduce health risks due to the strong link between health status and CRF. Completion of cardiovascular exercise is typically recommended for all adults to increase CRF, yet it takes a lot of time and may be perceived as boring. Alternatively, HIIT requires less time and tends to cause greater feelings of enjoyment in many adults. Hundreds of studies report an increase in CRF in response to HIIT in various groups of adults ranging from athletes and those with obesity, diabetes, cancer, stroke, and even spinal cord injury, which emphasizes the potency of this vigorous form of PA. Yet, many studies are weakened by a small sample size which questions the feasibility of these findings. This randomized controlled trial will test the efficacy and feasibility of a very small amount of HIIT, referred to as reduced exertion high intensity interval training (REHIT), in inactive adults. In the proposed study, REHIT will consist of 2 days per week of 1 to two 10 - 20 second sprints on a stationary bike. The proposed sample will include 60 adults who complete 18 sessions of REHIT over a 9 week period, and their responses will be compared to a non exercising control group. During the study, changes in CRF, fuel metabolism, and psychological responses will be monitored, with the latter outcome shedding light on the overall feasibility of HIIT in inactive adults. Overall, this novel study has profound public health applications as it will assess fitness and health related changes to a small dose of PA in the largest sample to date. If substantial changes in CRF are shown, these data have the potential to modify public health guidelines for implementing PA in inactive adults.

Global Overweight and oBesE (GLOBE) Patient Registry, Development and Implementation of Disease-specific: Severity, Quality of Life and Cost Instruments.

We are conducting this study to develop a disease-specific instrument, a quality of life instrument and a comprehensive list of costs associated with overweight and obesity.

Effect of Ketone Esters on Liver Fat Content and Metabolic Function

The goal of this clinical trial is to determine whether ingestion of a ketone ester drink helps improve liver health and blood glucose control. Ketones are a type of energy source made by the body during times of weight loss, low carbohydrate intake and starvation. People enrolled in this study will be randomly assigned (by chance, like the flip of a coin) to one of two groups: Group 1: Ketone ester drink consumed daily for 6 weeks. Group 2: Placebo drink consumed daily for 6 weeks.