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

Cambridge Health Alliance

Status: Enrolling

Conditions: Prediabetes; High Cholesterol/Hyperlipidemia; Diabetes; Obesity & Overweight; HDL Cholesterol; Triglycerides

Treatments: Other: Comparator; Other: Bottarga

Study type: Interventional

Funder types: Other

Identifiers

NCT06988462

CHA-IRB-24-25-346

Details and patient eligibility

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.

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.

Full description

Rationale/goals: Greek Bottarga (Grey mullet fish roe) is a traditional marine or "blue" food "that is produced in a sustainable manner. Bottarga's composition supports that it has excellent nutritional properties, but to date no human/clinical studies have been published. This pilot study will explore the potential benefits of Bottarga consumption in humans. If the results show potential benefits, this would help promote more sustainable blue foods. Methods: 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, who will consume 20 g/day of Bottarga. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers.

The current randomized, controlled, cross-over pilot study (Open Label, Two-Arms) will investigate the metabolic effects of daily bottarga supplementation (versus a calorically equal dairy product) in 20 participants with at least one metabolic abnormality for 8 weeks with a 2-week "washout" period between food supplement arms. The primary outcome will be determined based on the most clinically important results observed during phase 1. Anticipated Results: The investigators expect Bottarga supplementation to be associated with more beneficial changes on lipid profiles, inflammatory markers and insulin resistance compared to baseline measures and to the calorically equivalent comparator food.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• Pregnancy
• Clinical evidence or history of hepatic or renal insufficiency
• Immunodeficiency conditions
• History of non-skin cancer
• Participation in other clinical research studies

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Bottarga supplementation (intervention group)

Experimental group

Description:

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) 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), followed by final assessment measures.

Treatment:

Other: Bottarga

Cream cheese supplementation (control)

Sham Comparator group

Description:

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), followed by final assessment measures.

Treatment:

Other: Comparator