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

NCT06988462 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-19

No results posted yet for this study

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

Interventions

OTHER

Bottarga

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

OTHER

Comparator

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

Sponsors & Collaborators

  • Cambridge Health Alliance

    lead OTHER

Principal Investigators

  • Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD · Cambridge Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-17
Primary Completion
2026-08-25
Completion
2026-12-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06988462 on ClinicalTrials.gov