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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating how a physical activity program affects hormone health and diabetes risk in girls aged 8 to 12 who may be at higher risk for conditions like Polycystic Ovary Syndrome PCOS and insulin resistance. This pilot randomized trial aims to evaluate whether the ActiveGirls program effectively engages girls and their families to increase physical activity and to track changes in markers of diabetes risk and puberty hormones over one year. Participants are randomly assigned to either a full intensity intervention group or a delayed lower intensity comparison group. The full intensity group receives 3-4 educational messages per week via text or email and six health coaching visits via telemedicine during the first six months. The delayed lower intensity group receives only the educational messages during months 7 to 12. Both groups complete at-home activity monitoring and participate in study visits for health assessments. Participants will have baseline and 12-month in-person visits at the research center, with a remote assessment at 6 months. These visits include checks on body composition, insulin sensitivity, reproductive hormones, and physical fitness. Surveys about lifestyle behaviors and social-emotional wellness are completed by both participants and a caregiver. The study measures retention, acceptability, physical activity levels, insulin sensitivity changes, and hormone levels over the year-long participation period.

Age: 8Years +FEMALEPhase Not Applicable
1 location
S

Actively Recruiting

Healthy Volunteer

Researchers are evaluating the effects of different oral hygiene routines on the oral microbiome, inflammation, and gum health in people with gingivitis. This six-week, double-blind, randomized study compares mouthwash use combined with toothbrushing to a control group. Participants will be assessed for changes after four weeks of twice-daily oral care and again two weeks after stopping treatment to check oral tolerance and lasting effects. Participants will receive toothpaste and a toothbrush to use throughout the study. They will brush twice daily for one minute and then rinse either with distilled water, an assigned mouthwash, or one of several experimental or marketed rinses depending on their group. The first use of the products occurs under supervision at the study site, and participants will keep a diary to record their twice-daily product use. Throughout the study, researchers will collect oral plaque and saliva samples to analyze changes in the microbiome and measure gum health using indices like bleeding on probing, plaque amount, pocket depth, and gingival inflammation. These assessments take place at the start and after four weeks of treatment. The study monitors participants for safety and adherence, with a total participation period of six weeks including follow-up two weeks after treatment ends.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
1 location
P

Actively Recruiting

This research aims to explore the potential benefits of consuming Greek bottarga, a traditional sustainable marine food made from grey mullet fish roe, in adults aged 18 to 60 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 study includes a preliminary dose-testing phase and a randomized controlled crossover trial to evaluate changes in metabolic health markers. The preliminary phase involves five adults consuming 20 grams per day of bottarga, with clinical assessments before and after this dietary intervention. Following this, a crossover trial with 20 participants will compare daily bottarga supplementation against a calorically matched dairy product cream cheese for two 8-week periods separated by a 2-week washout. Participants weighing over 100 kg will receive double doses of each supplement. This design allows comparison of metabolic effects between the two dietary interventions. Participants will undergo clinical assessments including fasting glucose, inflammatory markers, HbA1c, and lipid profiles at baseline and after each intervention period. Secondary measures include body mass index, body fat, waist circumference, blood pressure, and liver enzymes. The study monitors changes throughout the intervention and washout phases, assessing potential benefits of bottarga on insulin resistance and inflammation over approximately 18 weeks per participant.

Age: 18Years - 60YearsAll GendersPhase Not Applicable
1 location