NCT06988462Recruiting
Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 16 May 2025
- Start date
- 17 Oct 2025
- Primary completion date
- 25 Dec 2026
- Lead sponsor
- Cambridge Health Alliance
- Diseases
- Obesity, Familial hypercholesterolaemia
- NCT number
- NCT06988462
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 17 Oct 2025 to the primary completion date, 25 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of illicit drugs (other than marijuana)
- Use of hormone therapy (except oral contraceptives)
Other illness
- Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression
- Known allergies to fish, seafood, or any fish-derived products, including bottarga
- Clinical evidence or history of hepatic or renal insufficiency
- Immunodeficiency conditions
- History of non-skin cancer
Other
- Current use of any supplements containing n-3 fatty acids
- Pregnancy
- Participation in other clinical research studies
Criteria the registry did not label
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge Health Alliance Coordinator of this site? Confirm its status | Sommerville | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.