Bottarga Supplementation for Prediabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD
Principal Investigator
Cambridge Health Alliance
Are You a Good Fit for This Trial?
This trial is for overweight, pre-diabetic adults. It's a small initial study to see if eating Greek Bottarga (fish roe) can improve their health. Participants will be tested before and after trying the food to check for changes in metabolic health.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preliminary Dose-Testing
Preliminary dose-testing study in five overweight and pre-diabetic adults consuming 20 g/day of Bottarga
Randomized Controlled Crossover Trial
Participants undergo an 8-week intervention with Bottarga or cream cheese supplementation, followed by a 2-week washout period, then crossover to the alternate intervention for another 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bottarga
- Comparator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cambridge Health Alliance
Lead Sponsor