Recruiting

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

Sponsor:

Cambridge Health Alliance

Code:

NCT06988462

Conditions

Prediabetes

Diabetes

High Cholesterol/Hyperlipidemia

Obesity & Overweight

Triglycerides

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Bottarga

Comparator

Study Details

Brief summary:

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.

Conditions

Prediabetes

Diabetes

High Cholesterol/Hyperlipidemia

Obesity & Overweight

Triglycerides

Study ID

NCT06988462

Start date

Oct 17, 2025

Status verified date

Jul, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Dec 25, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Bottarga supplementation (intervention group)

Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be randomly allocated to 8 weeks of daily bottarga supplementation (20 grams/day; participants weighing >100 kg \[220 lbs\] will consume 40 g/day) as an initial treatment. Baseline assessment measures will be repeated, followed by a 2-week wash-out period. Then, assessment measures will be repeated followed by 8 weeks of daily cream cheese supplementation (28 grams/day; participants weighing >100 kg \[220 lbs\] will consume 56 g/day), followed by final assessment measures.

sham comparator: Cream cheese supplementation (control)

Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be randomly allocated to 8 weeks of daily cream cheese supplementation (28 g/day) as the initial intervention. Baseline assessment measures will be repeated, followed by a 2-week wash-out period. Then, assessment measures will be repeated, followed by 8 weeks of daily Bottarga supplementation (20 g/day;participants weighing >100 kg \[220 lbs\] will consume 40 g/day), followed by final assessment measures.

Interventions

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.

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 measure

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 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 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 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). ]

Central Contacts and Locations

Locations

Cambridge Health Alliance

Recruiting

Sommerville, Massachusetts, United States, 02145

Contacts

Patricia Lenehan

617-665-1580 elidoriki@challiance.org

Principal Investigator:

Stefanos N Kales, MD

More Information

Sponsor

Cambridge Health Alliance

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

Bottarga
pre diabetes
inflammation
sustainability
nutritional intervention
overweight
metabolic abnormalities
lipid profile
diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cambridge Health Alliance on 2026-07-16.