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

Description

This pilot study aims to explore the potential benefits of consuming Greek Bottarga (grey mullet fish roe) in overweight, pre-diabetic individuals. Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five overweight and pre-diabetic adults.Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this, the investigators will proceed with a randomized, controlled crossover trial involving 20 overweight and pre-diabetic adults. This main study phase will compare the metabolic effects of daily Bottarga supplementation to those of a calorically matched dairy product over an 8-week period, with a 2-week washout period between interventions. The investigators anticipate that Bottarga supplementation will lead to improvements in lipid profiles, inflammation, and insulin resistance, which could promote the use of sustainable blue foods as part of a healthy diet.

Conditions

Prediabetes

Study Overview

Study Details

Study overview

This pilot study aims to explore the potential benefits of consuming Greek Bottarga (grey mullet fish roe) in overweight, pre-diabetic individuals. Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five overweight and pre-diabetic adults.Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this, the investigators will proceed with a randomized, controlled crossover trial involving 20 overweight and pre-diabetic adults. This main study phase will compare the metabolic effects of daily Bottarga supplementation to those of a calorically matched dairy product over an 8-week period, with a 2-week washout period between interventions. The investigators anticipate that Bottarga supplementation will lead to improvements in lipid profiles, inflammation, and insulin resistance, which could promote the use of sustainable blue foods as part of a healthy diet.

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

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

Condition
Prediabetes
Intervention / Treatment

-

Contacts and Locations

Sommerville

Cambridge Health Alliance, Sommerville, Massachusetts, United States, 02145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults aged 18 to 60 years
  • * Residents of Massachusetts
  • * Diagnosed with prediabetes
  • * Body Mass Index (BMI) greater than 27 kg/m²
  • * Otherwise healthy
  • * Not pregnant
  • * Willing to take a nutritional supplement
  • * Use of any medications for diabetes, dyslipidemia, or immunosuppression
  • * Current use of any supplements containing n-3 fatty acids
  • * Current use of tobacco/nicotine products, marijuana, or illicit drugs
  • * Self-reported consumption of a diet rich in plant- or marine-derived fats (e.g., fatty fish, nuts, seeds, or olive oil)
  • * 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 cardiac, pulmonary, hepatic, or renal insufficiency
  • * Immunodeficiency conditions
  • * History of non-skin cancer
  • * Participation in other clinical research studies

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cambridge Health Alliance,

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

Study Record Dates

2026-06-01