Clinical trials

Stearic acid and palmitic acid are two common consumed saturated fatty acids found in foods. Palmitic acid is associated with increases in blood cholesterol, whereas stearic acid is generally considered neutral with respect to blood cholesterol. However, the mechanisms underlying these different effects are not fully understood. The goal of this clinical trial is to determine how replacing dietary palmitic acid with stearic acid affects microorganisms living in the gastrointestinal tract (gut microbiome) and the metabolites they produce, including secondary bile acids, and whether these changes influence heart and metabolic health in postmenopausal women. The main question it aims to answer is whether the cholesterol lowering effect of dietary stearic acid, compared to dietary palmitic acid is due to changes in the composition and function of the gut microbiome and bile acid metabolism. Participants will consume a controlled diet high in palmitic acid for a 10-day run-in period, followed by a controlled diet high in stearic acid for 28 days. During the study, participants will provide biological samples, including blood samples collected in both fasting and non-fasting states, for assessment of cardiometabolic outcomes. Participants will also swallow mini-pills designed to collect samples from different regions of the gastrointestinal tract to assess the gut microbiome and related metabolites. Results will contribute to understanding the relationship between stearic acid mediated microbiota effects on cardiometabolic heath.

The goal of this observational study is to characterize and compare region-specific gastrointestinal, stool, oral, and periodontal microbiomes in adults with Sjögren's disease and healthy controls using ingestible mini-pill sampling technology. The study will include adults with Sjögren's disease and healthy control participants enrolled in a parent gastrointestinal microbiome study

The proposed project aims to implement and evaluate a novel, family-based lifestyle medicine intervention integrating group Shared Medical Appointments (SMAs) for parents and adolescents with a twelve-month medically tailored groceries (MTG) and six-month culinary medicine Food is Medicine program. The intervention provides adolescent weight wellness treatment through a holistic, community engaged approach leveraging family connection, clinical care, and nutrition support. Monthly SMAs will include time for parents and adolescents to meet independently and conclude together. These visits will be co-led by physicians, dietitians, and health professionals. Parents will receive the Ardmore Institute's Full Plate Living program while adolescents receive Tufts Pediatrics Strong, Positive and Resilient Kids (SPARK) Weight Wellness program. The SMA format is reimbursable, fosters peer support, enhances patient-provider interaction, and allows efficient delivery of education and care. Each session will include nutrition and lifestyle education, review of individualized weight care plans, and proactive goal setting tailored to adults, adolescents, and families.

Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk. Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs. This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.

Many people who use GLP-1 medications (such as semaglutide or tirzepatide) achieve meaningful weight loss, but maintaining that weight loss off after stopping the medication can be very challenging. Researchers at Tufts University are conducting a study to learn whether a digital lifestyle program can help people maintain their weight loss after they stop taking a GLP-1 medication. Adults who have recently stopped a GLP-1 medication may be eligible to participate. Participants will be randomly assigned to either receive access to a digital program or to continue with usual care. The study lasts 12 months and is fully remote. All participants will receive a Bluetooth scale to track weight from home and will complete short online questionnaires several times over the year. By taking part, participants can help researchers better understand how to support long-term weight maintenance in a way that is affordable, accessible, and sustainable. Participants are compensated for their time, and involvement may help improve care for others with similar experiences.

This study will evaluate a culinary nutrition intervention designed to improve the quality of meals served to older adults participating in a senior center. Many meals currently provided in these settings do not meet recommended dietary guidelines, which negatively impact health outcomes among older adults. In this pilot study, participants will receive improved lunch meals that are designed to be more nutritious, culturally appropriate, and acceptable, along with nutrition education sessions over a 6-month period. This intervention will also include training for food service staff to support implementation of the improved meals. The study will assess changes in dietary quality, physical health measures, and social and behavioral outcomes among participants at baseline, 3 months, and 6 months. Findings from this study will help determine the feasibility and effectiveness of this approach and inform future efforts to improve nutrition and health outcomes in Congregate Meal Program for older adults.

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.

The purpose of this study is to compare how well our research participants heal with two different kind of healing abutments used. One is pre-fabricated, meaning it is made to fit anyone, and the other is customized to fit the subject specifically. Much of what will occur is 'standard of care' meaning it is part of a subject's typical dental treatment and the research team wants to just look at the data for this research study, as well.

The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a "mini-pill", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.

Current health devices often overlook older users, who may face both health challenges and technology barriers. We are investigating the feasibility of wearable sensors to track posture, heart rate, and breathing, alongside a microneedle patch that collect body fluids to measure stress and inflammation markers. By combining this data, we aim to create an easy to use system that supports personalized, at home health monitoring for older adults.

The primary aim of this study will be to compare the effectiveness of the novel LumiCare™ rinse and with QLF in determining caries progression. The secondary aim is to compare the progression of carious lesions between patients who reported use of e-cigarettes/vapes and those who did not.

The purpose of this study is to evaluate the use of various techniques in alleviating gag reflex following gag reflex stimulation. Primary aim: To compare if there is any reduction in gag reflex from each of the following interventions * Acupuncture (CV-24) * Tape * Anesthetic spray Secondary aim: to compare the degree of gag reduction

Using a two-group randomized study design, this study aims to evaluate the effectiveness of the adapted family-centered mHealth tool on child BMI z-score (primary outcome), child dietary behaviors, and parental feeding practices, from baseline to 12-month follow-up, among 200 child-parent dyads. It is hypothesized that children in the experimental group will demonstrate larger BMI-z score improvements between baseline and 12-month follow-up compared to children in the comparison group.

The goal of this clinical trial is to generate evidence on the feasibility and effectiveness of community pharmacies as the implementers of a produce prescription program for adults with diabetes and/or hypertension. The main question this study plans to answer is if using community pharmacies as a point-of-service for improving nutrition and health is feasible and effective. The trial also explores the impact of the program on food security, nutrition security, diet quality and health and patient centered outcomes. Participants will be enrolled in a produce prescription program to purchase healthy foods at the grocery store where they are currently receiving their pharmacy services. Participants will be asked to attend pharmacy visits to collect biometrics at two different time points and complete electronic surveys at three different time points.

In this study, patients who have undergone facial paralysis surgery will be asked to participate. The goal of this study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. The focus point of this study will be on outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation. The specific aims of the study are as follows. Specific Aim 1. To quantitatively determine the surgical effects/impact on facial disability (facial impairment and disfigurement) among four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer driven by (1) a trigeminal nerve (nV) graft, (2) a crossface nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification. 1. We will compare the changes in facial disability among the groups before and after surgery, and the differences in facial disability between each surgery group and the controls before and after surgery. 2. Specific Aim 2. To compare among the surgery groups the changes in self-perceptions of facial appearance and well-being that occur due to facial reanimation surgery, and to compare the surgery groups before and at 18 months to historical controls recruited during the tenure of the R21 grant. 3. Specific Aim 3. In patients with facial paralysis, to compare surgeons' current qualitative assessment and 2D, quantitative assessment of facial impairment and disfigurement with the objective, 3D, quantitative assessments in order to determine the clinical utility of the 3D assessment approach as an outcome measure and relevance for dissemination to the surgical community.

The IWCR is a global scientific study aimed at better understanding the opportunities and barriers for reducing the prevalence of obesity by collecting information from people who have experience with weight management in their everyday lives. The investigators seek to gather information on a wide range of weight management experiences, ranging from weight loss and weight loss maintenance to weight gain and inability to lose weight.