Bottarga Supplementation for Prediabetes

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Cambridge Health Alliance

Must not be taking: Diabetes meds, Dyslipidemia meds

Disqualifiers: Tobacco use, Hormone therapy, Allergies, others

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

Compensation: Varies

Number of Visits: 6

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether eating Greek Bottarga (fish roe) can improve health markers such as insulin resistance and inflammation in individuals who are overweight and have prediabetes. Participants will compare the effects of daily Bottarga supplementation to consuming a similar amount of cream cheese over an 8-week period, with a short break between the two. This study could lead to new dietary options for improving metabolic health. Suitable candidates have prediabetes, live in Massachusetts, and are willing to take a nutritional supplement. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance dietary recommendations for metabolic health.

Will I have to stop taking my current medications?

If you are taking medications for diabetes, cholesterol issues, or immune system suppression, you cannot participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows no current clinical data on the safety of Bottarga supplements in humans. This study is the first to examine Bottarga's effects on metabolic health in people with pre-diabetes. Made from grey mullet fish roe, Bottarga is generally safe to eat, but specific safety information from human studies is not yet available.

This trial is a pilot study, offering an initial look at Bottarga's safety and effects. Participants will begin with a small dose to observe their body's reactions. This careful approach helps identify any side effects early. As the first study of its kind, participants will provide valuable information about Bottarga's impact on health. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for prediabetes, such as lifestyle changes and medications like metformin, Bottarga supplementation is derived from cured fish roe, offering a unique nutritional approach. Researchers are excited because Bottarga is rich in omega-3 fatty acids and antioxidants, which may help improve insulin sensitivity and reduce inflammation. This natural supplement could provide a simpler, dietary-based alternative to traditional drug therapies, potentially offering a new way to manage blood sugar levels without the side effects associated with some medications.

What evidence suggests that Bottarga supplementation might be an effective treatment for prediabetes?

Research has shown that Bottarga, fish eggs from grey mullet, might improve health markers in people with prediabetes. Studies suggest that Bottarga can lead to healthier cholesterol and fat levels in the blood, reduce inflammation, and improve insulin use. These changes are important for managing or preventing the progression of prediabetes. Although direct evidence from human trials remains limited, the nutrients in Bottarga support these potential health benefits. In this trial, participants will receive Bottarga supplementation to evaluate its potential as an option for improving metabolic health. ^{1 2 3 4 6}

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

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

Known allergies to fish, seafood, or any fish-derived products, including bottarga

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?

Group I: Bottarga supplementation (intervention group) Experimental Treatment 1 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 Group 1 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.

Who Is Running the Clinical Trial?

Cambridge Health Alliance

Lead Sponsor

Trials

65

Recruited

22,400+

Citations

1. mdpi.com mdpi.com/2076-3417/15/18/9877

Nutritional Analysis of Bottarga and Pilot Study Protocol for ... We expect bottarga supplementation to be associated with more beneficial metabolic changes compared to baseline measures and to the calorically equivalent ...

2. researchgate.net researchgate.net/publication/395445277_Nutritional_Analysis_of_Bottarga_and_Pilot_Study_Protocol_for_Bottarga_Supplementation_in_Individuals_with_Prediabetes

Nutritional Analysis of Bottarga and Pilot Study Protocol for ... We expect bottarga supplementation to be associated with more beneficial metabolic changes compared to baseline measures and to the calorically ...

3. scilit.com scilit.com/publications/5b5ecf6ad1afa5fd70094930a39b831a

Nutritional Analysis of Bottarga and Pilot Study Protocol for ... We expect bottarga supplementation to be associated with more beneficial metabolic changes compared to baseline measures and to the calorically equivalent ...

4. withpower.com withpower.com/trial/bottarga-supplementation-for-prediabetes-19210

Bottarga Supplementation for Prediabetes This pilot study aims to explore the potential benefits of consuming Greek Bottarga (grey mullet fish roe) in overweight, pre-diabetic individuals.

5. clinconnect.io clinconnect.io/trials/NCT06988462

Pilot Study of "Bottarga" Supplementation: A - ClinConnect This pilot study aims to explore the potential benefits of consuming Greek Bottarga (grey mullet fish roe) in overweight, pre-diabetic individuals.

6. malacards.org malacards.org/card/prediabetes_syndrome

Prediabetes Syndrome Integrated disease information for Prediabetes Syndrome including associated genes, mutations, phenotypes, pathways, drugs, and more - integrated from 78 ...