Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
NCT06988462

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

Led by Cambridge Health Alliance · Updated on 2026-02-19

20

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18-60 years
  • Residents of Massachusetts
  • Have at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c 65 5.7%) or a diagnosis of diabetes
  • Not pregnant
  • Willing to consume a nutritional supplement and follow study procedures
Not Eligible

You will not qualify if you...

  • Use of medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression
  • Taking 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 fish-derived products including bottarga
  • Pregnancy
  • History or clinical evidence of liver or kidney problems
  • Having immunodeficiency conditions
  • History of non-skin cancer
  • Currently participating in other clinical research studies

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Trial Site Locations

Total: 1 location

1

Cambridge Health Alliance

Sommerville, Massachusetts, United States, 02145

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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