Status:
RECRUITING
Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
Lead Sponsor:
Cambridge Health Alliance
Conditions:
Prediabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This pilot study aims to explore the potential benefits of consuming Greek Bottarga (grey mullet fish roe) in overweight, pre-diabetic individuals. Before initiating the crossover randomized controll...
Detailed Description
Rationale/goals: Greek Bottarga (Grey mullet fish roe) is a traditional marine or "blue" food "that is produced in a sustainable manner. Bottarga's composition supports that it has excellent nutrition...
Eligibility Criteria
Inclusion
- Adults aged 18 to 60 years
- Residents of Massachusetts
- Diagnosed with prediabetes
- Body Mass Index (BMI) greater than 27 kg/m²
- Otherwise healthy
- Not pregnant
- Willing to take a nutritional supplement
Exclusion
- Use of any medications for diabetes, dyslipidemia, or immunosuppression
- Current use of any supplements containing n-3 fatty acids
- Current use of tobacco/nicotine products, marijuana, or illicit drugs
- Self-reported consumption of a diet rich in plant- or marine-derived fats (e.g., fatty fish, nuts, seeds, or olive oil)
- 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 cardiac, pulmonary, hepatic, or renal insufficiency
- Immunodeficiency conditions
- History of non-skin cancer
- Participation in other clinical research studies
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06988462
Start Date
June 25 2025
End Date
June 1 2026
Last Update
June 22 2025
Active Locations (1)
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1
Cambridge Health Alliance
Sommerville, Massachusetts, United States, 02145