20 Participants Needed

Bottarga Supplementation for Prediabetes

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

SN

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

I am a healthy adult from Massachusetts, aged 18-60, not pregnant, with a BMI over 27, and interested in a nutritional supplement.

Exclusion Criteria

Current use of any supplements containing n-3 fatty acids
Current use of tobacco/nicotine products, marijuana, or illicit drugs
I am not using hormone therapy, except for birth control pills.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preliminary Dose-Testing

Preliminary dose-testing study in five overweight and pre-diabetic adults consuming 20 g/day of Bottarga

4 weeks
2 visits (in-person)

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

18 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bottarga
  • Comparator
Trial Overview The study tests whether daily Bottarga supplementation improves lipid profiles, inflammation markers, and insulin resistance compared to a calorically matched dairy product. The design includes a preliminary dose-testing phase followed by an RCT with crossover and washout periods.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bottarga supplementation (intervention group)Experimental Treatment1 Intervention
Ten overweight and pre-diabetic participants 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.
Group II: Cream cheese supplementation (control)Placebo Group1 Intervention
Ten overweight and pre-diabetic participants 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials
65
Recruited
22,400+
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