Exploring the benefits of Bottarga supplementation for prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study investigates the effects of Greek Bottarga, a sustainable marine food, on overweight individuals diagnosed with prediabetes. Initially, a dose-testing phase will assess the impact of daily Bottarga consumption on metabolic health markers in five participants. Following this, a randomized controlled crossover trial will compare the metabolic effects of Bottarga supplementation against a calorically matched dairy product over an 8-week period, with a 2-week washout phase. The study aims to evaluate improvements in lipid profiles, inflammation, and insulin resistance.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Cambridge Health Alliance
  Sommerville, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD — Cambridge Health Alliance

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.