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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCambridge Health Alliance

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Bottarga
  • Comparator

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators