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

RecruitingNAAges 18 Years - 60 YearsAllCambridge Health Alliance
NCT06988462 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-we

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📋 Eligibility rules (as published)
* 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
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What it tests

  • Bottarga
  • Comparator
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Where

1 site
Cambridge Health Alliance
Sommerville, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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