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

NCT06988462 | Recruiting

• 1 other identifier: CHA-IRB-24-25-346
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; HDL Cholesterol

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Mean change in fasting glucose

  Mean change in fasting glucose levels (mg/dL) after overnight fast.

  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)

  Mean change in serum hs-CRP levels (mg/L) after overnight fast.

  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)

  Mean change in HbA1c levels (%) after overnight fast.

  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)

  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.

  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).

Secondary Outcomes (6)

• Mean change in body mass index

  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 body fat

  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 waist circumference

  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 waist/hip ratio

  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 resting blood pressure

  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).

Study Arms (2)

Bottarga supplementation (intervention group)

EXPERIMENTAL

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.

Other: Bottarga

Cream cheese supplementation (control)

SHAM COMPARATOR

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.

Other: Comparator

Interventions

Bottarga OTHER

Participants will consume prepackaged daily doses of Bottarga, each containing the required amount (20 grams/day) for 8 weeks.

Bottarga supplementation (intervention group)

Comparator OTHER

Participants will consume 28g of cream cheese/day for 8 weeks.

Cream cheese supplementation (control)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge Health Alliance: lead

Study Sites (1)

Cambridge Health Alliance

Sommerville, Massachusetts, 02145, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus; Hypercholesterolemia; Hyperlipidemias; Obesity; Overweight; Glucose Intolerance; Inflammation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Pathologic Processes

Study Officials

• Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD

  Cambridge Health Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, controlled, open-label, crossover pilot study will investigate the metabolic effects of daily Bottarga supplementation, compared to a calorically matched dairy product, in 20 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. Each intervention will last 8 weeks, separated by a 2-week washout period.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 23, 2025
• Study Start: October 17, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 19, 2026

Record last verified: 2025-06

Locations

US (1)