NCT06988462 · Cambridge Health Alliance
Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
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.
View original scientific description
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.
Interventions
OTHER
Bottarga
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.
OTHER
Comparator
Participants will consume 28g of cream cheese/day (participants weighing \>100 kg \[220 lbs\] will consume 56 g/day) for 8 weeks.
Primary outcome measures
Mean change in fasting glucose
Time frame: 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 glucose levels (mg/dL) after overnight fast.
Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
- Clinical evidence or history of hepatic or renal insufficiency
- Immunodeficiency conditions
- History of non-skin cancer
- Participation in other clinical research studies
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
- Clinical evidence or history of hepatic or renal insufficiency
- Immunodeficiency conditions
- History of non-skin cancer
- Participation in other clinical research studies
Where
- Sommerville, Massachusetts
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations