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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Researchers are investigating how a physical activity program may affect hormone health and diabetes risk in girls aged 8 to 12 who might be at higher risk for conditions like Polycystic Ovary Syndrome (PCOS) and insulin resistance. This pilot randomized trial compares an intensive physical activity intervention with health coaching and educational messages against a delayed, lower intensity intervention that includes only educational messages. The study aims to understand if the 'ActiveGirls' program effectively engages girls and their families to increase physical activity, and how markers of diabetes risk and puberty hormones change over one year in relation to physical activity levels. Participants are assigned to one of two groups: a full intensity intervention group that receives six telemedicine health coaching visits and 3-4 educational text messages per week for the first six months, or a delayed lower intensity group that receives only educational text messages 3-4 times per week during months seven through twelve. Both groups complete activity monitoring at home and attend study visits at specific intervals. During the study, participants and a caregiver will complete surveys about lifestyle behaviors and emotional wellness. There are three assessment points: baseline and 12-month visits at the research center for physical exams and tests, and a remote 6-month assessment. Researchers will measure body composition, insulin function, reproductive hormones, physical activity, and fitness to evaluate retention and acceptability of the program over 12 months.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating how different oral hygiene routines affect the mouth's microbiome, inflammation, and gum health in people with gingivitis. This six-week, double-blind, randomized study compares several mouthwash products to a control group using distilled water. The goal is to observe changes in oral bacteria, immune responses, and gum condition after four weeks of treatment, with a follow-up two weeks after stopping the treatments to assess lasting effects. Participants will use their assigned oral hygiene regimen twice daily, which includes brushing and rinsing with either distilled water, marketed mouthwash products, or prototype rinses. The study groups include five different intervention arms, each using their specific mouthwash or distilled water. The treatment period lasts four weeks, followed by a two-week observation phase without treatments to evaluate oral tolerance and any changes after stopping. During the study, participants will have samples taken from the plaque on their teeth at the start and after four weeks to measure changes in the oral microbiome. Researchers will assess gum health using clinical indices and measure inflammatory markers. Participants will be monitored for safety and adherence throughout the six-week period. The primary outcome is the change in the profiles of bacteria in the mouth plaque after the treatment and follow-up phases.
Actively Recruiting
This research investigates the possible health benefits of consuming Greek bottarga, a traditional sustainable marine food made from grey mullet fish roe. The study focuses on adults aged 18 to 60 years who have at least one metabolic abnormality, such as low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, elevated HbA1c, or a diagnosis of diabetes. The goal is to explore how bottarga might impact metabolic health markers like lipid profiles, inflammation, and insulin resistance. The study begins with a preliminary dose-testing phase involving five adults who consume 20 grams of bottarga daily. After this, a randomized, controlled crossover trial will enroll 20 eligible participants. During the main trial, participants will consume daily doses of bottarga (20 grams) for 8 weeks and, in a separate period after a 2-week washout, consume 28 grams of cream cheese daily for 8 weeks. The crossover design allows comparison between the effects of bottarga supplementation and a calorically matched dairy product. Participants will undergo clinical assessments before and after each intervention period to measure changes in fasting glucose, inflammatory markers like high-sensitivity C-reactive protein, hemoglobin A1c, and lipid profiles including total cholesterol, triglycerides, HDL-C, and LDL-C. Researchers will monitor adherence to the dietary interventions and evaluate the metabolic effects throughout the study. The total participation includes both intervention periods and the washout, lasting over 18 weeks in total.