Exploring the benefits of Bottarga supplementation for prediabetes
Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
This study is testing if adding Greek Bottarga to the diet can help overweight people with prediabetes improve their metabolic health compared to a similar dairy product.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Cambridge Health Alliance Academic / other |
| Locations | 1 site (Sommerville, Massachusetts) |
| Trial ID | NCT06988462 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of Greek Bottarga, a sustainable marine food, on overweight individuals diagnosed with prediabetes. Initially, a dose-testing phase will assess the impact of daily Bottarga consumption on metabolic health markers in five participants. Following this, a randomized controlled crossover trial will compare the metabolic effects of Bottarga supplementation against a calorically matched dairy product over an 8-week period, with a 2-week washout phase. The study aims to evaluate improvements in lipid profiles, inflammation, and insulin resistance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 years, residing in Massachusetts, with a diagnosis of prediabetes and a BMI greater than 27 kg/m².
Not a fit: Patients currently on diabetes medications, those with certain dietary restrictions, or those with specific health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve metabolic health in prediabetic patients.
How similar studies have performed: While no human studies on Bottarga have been published, the exploration of sustainable marine foods in dietary interventions is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Sommerville, Massachusetts
- Cambridge Health Alliance — Sommerville, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD — Cambridge Health Alliance
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.