RECRUITINGINTERVENTIONAL

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

About This Trial

This pilot study aims to explore the potential benefits of consuming Greek bottarga (grey mullet fish roe) in individuals with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes. Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this phase, the investigators will proceed with a randomized, controlled crossover trial involving 20 eligible adult participants. This main study phase will compare the metabolic effects of daily bottarga supplementation with those of a calorically matched dairy product over an 8-week intervention period, with a 2-week washout period between interventions. The investigators anticipate that bottarga supplementation will improve lipid profiles, inflammation markers, and insulin resistance, thereby supporting the potential use of sustainable blue foods as part of a healthy diet.

Who May Be Eligible (Plain English)

* Adults aged 18-60 years - Residents of Massachusetts - Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes - Not pregnant - Willing to consume a nutritional supplement and comply with study procedures Who Should NOT Join This Trial: - Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression - Current use of any supplements containing n-3 fatty acids - Current use of illicit drugs (other than marijuana) - Use of hormone therapy (except oral contraceptives) - Known allergies to fish, seafood, or any fish-derived products, including bottarga - Pregnancy - Clinical evidence or history of hepatic or renal insufficiency - weakened immune system conditions - History of non-skin cancer - Participation in other clinical research studies Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

* Adults aged 18-60 years * Residents of Massachusetts * Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes * Not pregnant * Willing to consume a nutritional supplement and comply with study procedures Exclusion Criteria: * Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression * Current use of any supplements containing n-3 fatty acids * Current use of illicit drugs (other than marijuana) * Use of hormone therapy (except oral contraceptives) * Known allergies to fish, seafood, or any fish-derived products, including bottarga * Pregnancy * Clinical evidence or history of hepatic or renal insufficiency * Immunodeficiency conditions * History of non-skin cancer * Participation in other clinical research studies

Treatments Being Tested

OTHER

Bottarga

Participants will consume prepackaged daily doses of Bottarga, each containing the required amount (20 grams/day) for 8 weeks.

OTHER

Comparator

Participants will consume 28g of cream cheese/day for 8 weeks.

Locations (1)

Cambridge Health Alliance

Sommerville, Massachusetts, United States