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Pilot Study of Bottarga Supplementation for Metabolic Health

This pilot study is looking at whether consuming Bottarga (a type of fish roe) can help people with conditions like prediabetes, diabetes, high cholesterol, or obesity. Researchers want to see if Bottarga can improve markers of metabolic health, such as fasting glucose, HbA1c (a measure of average blood sugar), and hs-CRP (a marker of inflammation). You might be able to join if you are between 18 and 60 years old, live in Massachusetts, and have at least one metabolic abnormality or a diagnosis of diabetes. The study will compare Bottarga to cream cheese, and will involve 20 participants. The current status of the study is unclear.

Study design
This is a randomized, controlled crossover pilot study involving 20 participants. It is an open-label study, meaning both participants and researchers will know which intervention is being received.
What's involved
You would consume either Bottarga or cream cheese daily for 8 weeks, with a 2-week break, then switch to the other supplement for another 8 weeks. Clinical assessments will be done before and after each dietary intervention.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at the end of the initial 8-week intervention period and again at the end of the second 8-week intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06988462

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

Recruiting
NAAges 18–60InterventionalPrevention
Cambridge Health Alliance
~20 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:BottargaComparator

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean change in fasting glucose
Measured over 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).
+3 more outcomes measured

Conditions

Prediabetes
Diabetes
High Cholesterol/Hyperlipidemia
Obesity & Overweight
Triglycerides
HDL Cholesterol

Explore related trials

Diabetes MellitusHyperlipidemiaObesityPrediabetes

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD · PRINCIPAL_INVESTIGATOR · Cambridge Health Alliance

Who to contact

Patricia Lenehan
[email protected]
617-665-1580
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • 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.