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NCT Number: NCT06988462

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

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.

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Key information

Conditions

PreDiabetes Body Weight Diabetes Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders HDL Cholesterol High Cholesterol/Hyperlipidemia Hypercholesterolemia Hyperglycemia Hyperlipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Prediabetic State Signs and Symptoms Triglycerides

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cambridge Health Alliance

Sommerville, Massachusetts, 02145, United States

Location status: Recruiting

Location contact

Patricia Lenehan

CONTACT

[email protected]

617-665-1580

Stefanos N Kales, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Bottarga

Other

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

Other

Participants will consume 28g of cream cheese/day (participants weighing >100 kg [220 lbs] will consume 56 g/day) for 8 weeks.

Primary outcomes

  1. 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 fasting glucose levels (mg/dL) after overnight fast.

  2. 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 serum hs-CRP levels (mg/L) after overnight fast.

  3. 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 HbA1c levels (%) after overnight fast.

  4. 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).

    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.

Secondary outcomes

  1. Mean change in body mass index

    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).

    Body Mass Index (kg/m-squared)

  2. Mean change in body fat

    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).

    Body fat percentage as measured by bioelectrical impedance

  3. Mean change in waist circumference

    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).

    Waist circumference (cm)

  4. Mean change in waist/hip ratio

    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).

    Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)

  5. Mean change in resting blood pressure

    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).

    Resting systolic and diastolic blood pressure (mmHg), measured using calibrated automated sphygmomanometers.

  6. Mean change in liver enzymes

    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).

    Aspartate aminotransferase (AST, U/L), Alanine aminotransferase (ALT, U/L), Alkaline phosphatase (ALP, U/L) after overnight fast.

Sponsors and collaborators

Lead sponsor

Cambridge Health Alliance

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 23, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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