Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
Launched by CAMBRIDGE HEALTH ALLIANCE · May 16, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the potential benefits of a special food called Greek Bottarga, which comes from the roe (eggs) of grey mullet fish, for people who are overweight and at risk of developing diabetes (a condition known as prediabetes). The goal is to see if adding Bottarga to their diet can improve health markers such as fat levels in the blood, inflammation, and insulin resistance, which can help in managing blood sugar levels. The study will first test different amounts of Bottarga with a small group of participants, and then expand to compare the effects of Bottarga to a similar amount of a dairy product over eight weeks.
To participate in this study, you need to be a healthy adult aged 18 to 60 living in Massachusetts, be overweight (with a body mass index over 27), and have prediabetes. You cannot be on any diabetes medications or certain other treatments, and you should not have any allergies to fish or seafood. Participants will be monitored before and after the study to track any changes in their health. This trial is also a great opportunity to explore the use of sustainable foods in improving health, and participants will be helping to advance research in this area.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Cambridge Health Alliance
Cambridge Health Alliance (CHA) is a prominent healthcare system in Massachusetts, dedicated to providing high-quality, community-centered health services. As a clinical trial sponsor, CHA leverages its robust research infrastructure and commitment to innovation to advance medical knowledge and improve patient outcomes. With a focus on diverse populations, CHA conducts clinical trials across various therapeutic areas, ensuring that research is inclusive and reflective of the community it serves. The organization is committed to ethical standards and regulatory compliance, fostering collaboration among healthcare professionals, researchers, and participants to drive advancements in clinical care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sommerville, Massachusetts, United States
Patients applied
Trial Officials
Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD
Principal Investigator
Cambridge Health Alliance
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported