RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-30
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06988462

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18 to 60 years
  2. * Residents of Massachusetts
  3. * Diagnosed with prediabetes
  4. * Body Mass Index (BMI) greater than 27 kg/m²
  5. * Otherwise healthy
  6. * Not pregnant
  7. * Willing to take a nutritional supplement
  1. * Use of any medications for diabetes, dyslipidemia, or immunosuppression
  2. * Current use of any supplements containing n-3 fatty acids
  3. * Current use of tobacco/nicotine products, marijuana, or illicit drugs
  4. * Self-reported consumption of a diet rich in plant- or marine-derived fats (e.g., fatty fish, nuts, seeds, or olive oil)
  5. * Use of hormone therapy (except oral contraceptives)
  6. * Known allergies to fish, seafood, or any fish-derived products, including bottarga
  7. * Pregnancy
  8. * Clinical evidence or history of cardiac, pulmonary, hepatic, or renal insufficiency
  9. * Immunodeficiency conditions
  10. * History of non-skin cancer
  11. * Participation in other clinical research studies

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Cambridge Health Alliance
Sommerville, Massachusetts, 02145
United States

Collaborators and Investigators

Sponsor: Cambridge Health Alliance

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-30
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2025-05-30
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Bottarga
  • pre diabetes
  • inflammation
  • sustainability
  • nutritional intervention
  • overweight

Additional Relevant MeSH Terms

  • Prediabetes