No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
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At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
20 (estimated)
Sponsor
Cambridge Health Alliance · Other
Who this trial is looking for
This trial is looking for adults with metabolic health issues, like high cholesterol or diabetes, to see if eating a fish product called bottarga can improve their health. Participants will take bottarga or a dairy product for 8 weeks and will have health checks before and after the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am aged between 18 and 60 years old.
I live in Massachusetts.
I have one of the following: high cholesterol, high triglycerides, obesity, or diabetes.
I am not pregnant.
I am willing to take a nutritional supplement.
You may not be able to join if
I take medications for diabetes (except metformin).
I take medications for high cholesterol (except statins).
I am using n-3 fatty acid supplements.
I use illicit drugs (other than marijuana).
I have allergies to fish or seafood.
I have liver or kidney problems.
I have had cancer (not skin cancer) in the past.
I am part of another clinical study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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-te…
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.
Trial Locations
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Status
Eligibility 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…
* 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
Contacts
No contact information available.
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