Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06988462

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionPrediabetes, Diabetes, High Cholesterol/Hyperlipidemia, Obesity & Overweight, Triglycerides, HDL Cholesterol

Full registry criteria

* 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 Exclusion Criteria: * 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) * Known allergies to fish, seafood, or any fish-derived products, including bottarga * Pregnancy * Clinical evidence or history of hepatic or renal insufficiency * Immunodeficiency conditions * History of non-skin cancer * Participation in other clinical research studies

Treatments and study arms

Bottarga

Other

Participants will consume prepackaged daily doses of Bottarga, each containing the required amount (20 grams/day; participants weighing \>100 kg \[220 lbs\] will consume 40 g/day) for 8 weeks.

Comparator

Other

Participants will consume 28g of cream cheese/day (participants weighing \>100 kg \[220 lbs\] will consume 56 g/day) for 8 weeks.

Primary outcomes

Mean change in fasting glucoseFrom baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Mean change in fasting glucose levels (mg/dL) after overnight fast.

Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Mean change in serum hs-CRP levels (mg/L) after overnight fast.

Mean Change in Hemoglobin A1c (HbA1c)From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Mean change in HbA1c levels (%) after overnight fast.

Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C)From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Mean change in fasting lipid levels-including total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), and low-density lipoprotein cholesterol (LDL-C, mg/dL after overnight fast.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cambridge Health Alliance🇺🇸 Sommerville, Massachusetts, United States

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Patricia LenehanContact

Email · Call 617-665-1580

Stefanos N Kales, MDPrincipal Investigator