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

ConditionsPrediabetesDiabetesHigh Cholesterol/HyperlipidemiaObesity & OverweightTriglyceridesHDL Cholesterol
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCambridge Health Alliance

About this trial

This pilot study aims to explore the potential benefits of consuming Greek bottarga (grey mullet fish roe) in individuals with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes.

Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five adults with at least one metabolic abnormality. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers. Following this phase, the investigators will proceed with a randomized, controlled crossover trial involving 20 eligible adult participants. This main study phase will compare the metabolic effects of daily bottarga supplementation with those of a calorically matched dairy product over an 8-week intervention period, with a 2-week washout period between interventions.

The investigators anticipate that bottarga supplementation will improve lipid profiles, inflammation markers, and insulin resistance, thereby supporting the potential use of sustainable blue foods as part of a healthy diet.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-60 years

Residents of Massachusetts

Presence of at least one metabolic abnormality (low HDL cholesterol, elevated LDL cholesterol, elevated triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes

Not pregnant

Disqualifiers

Use of any medications for diabetes (except metformin), dyslipidemia (except statins), or immunosuppression

Current use of any supplements containing n-3 fatty acids

Current use of illicit drugs (other than marijuana)

Use of hormone therapy (except oral contraceptives)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Bottarga

    Other intervention

    Participants will consume prepackaged daily doses of Bottarga, each containing the required amount (20 grams/day; participants weighing \>100 kg \[220 lbs\] will consume 40 g/day) for 8 weeks.

  • Comparator

    Other intervention

    Participants will consume 28g of cream cheese/day (participants weighing \>100 kg \[220 lbs\] will consume 56 g/day) for 8 weeks.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Bottarga supplementation (intervention group)Experimental treatment 1 intervention
Group B: Cream cheese supplementation (control)Sham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change in fasting glucose

Mean change in fasting glucose levels (mg/dL) after overnight fast.

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
2

Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)

Mean change in serum hs-CRP levels (mg/L) after overnight fast.

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
3

Mean Change in Hemoglobin A1c (HbA1c)

Mean change in HbA1c levels (%) after overnight fast.

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
4

Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C)

Mean change in fasting lipid levels-including total cholesterol (mg/dL), triglycerides (mg/dL), high-density lipoprotein cholesterol (HDL-C, mg/dL), and low-density lipoprotein cholesterol (LDL-C, mg/dL after overnight fast.

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Secondary outcomes

1

Mean change in body mass index

Body Mass Index (kg/m-squared)

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
2

Mean change in body fat

Body fat percentage as measured by bioelectrical impedance

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
3

Mean change in waist circumference

Waist circumference (cm)

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).
4

Mean change in waist/hip ratio

Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)

Time frame
From baseline (start of the intervention) to Week 8 (end of the initial intervention period, prior to crossover), and from Week 10 to Week 18 (end of the second intervention period following crossover).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cambridge Health Alliance

Lead sponsor

Source ClinicalTrials.gov
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