Pilot Study to Explore Metabolic Benefits of Daily Bottarga Fish Roe Supplementation Compared to Cream Cheese in Adults with Metabolic Abnormalities or Diabetes Aged 18-60

What this Trial Is About

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.

Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food