Clinical trial NCT06988462: Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
Official title: Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetes
Keywords: Bottarga
pre diabetes
inflammation
sustainability
nutritional intervention
overweight
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, controlled, open-label, crossover pilot study will investigate the metabolic effects of daily Bottarga supplementation, compared to a calorically matched dairy product, in 20 overweight and pre-diabetic participants. Each intervention will last 8 weeks, separated by a 2-week washout period.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Rationale/goals: Greek Bottarga (Grey mullet fish roe) is a traditional marine or "blue" food "that is produced in a sustainable manner. Bottarga's composition supports that it has excellent nutritional properties, but to date no human/clinical studies have been published. This pilot study will explore the potential benefits of Bottarga consumption in humans. If the results show potential benefits, this would help promote more sustainable blue foods. Methods: Before initiating the crossover randomized controlled trial (RCT), the investigators will conduct a preliminary dose-testing study in five overweight and pre-diabetic adults, who will consume 20 g/day of Bottarga. Participants will undergo clinical assessments before and after the dietary intervention to evaluate changes in metabolic health markers.

The current randomized, controlled, cross-over pilot study (Open Label, Two-Arms) will investigate the metabolic effects of daily bottarga supplementation (versus a calorically equal dairy product) in 20 overweight and pre-diabetic participants for 8 weeks with a 2-week "washout" period between food supplement arms. The primary outcome will be determined based on the most clinically important results observed during phase 1. Anticipated Results: The investigators expect Bottarga supplementation to be associated with more beneficial changes on lipid profiles, inflammatory markers and insulin resistance compared to baseline measures and to the calorically equivalent comparator food.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 60 years
* Residents of Massachusetts
* Diagnosed with prediabetes
* Body Mass Index (BMI) greater than 27 kg/m²
* Otherwise healthy
* Not pregnant
* Willing to take a nutritional supplement

Exclusion Criteria:

* Use of any medications for diabetes, dyslipidemia, or immunosuppression
* Current use of any supplements containing n-3 fatty acids
* Current use of tobacco/nicotine products, marijuana, or illicit drugs
* Self-reported consumption of a diet rich in plant- or marine-derived fats (e.g., fatty fish, nuts, seeds, or olive oil)
* Use of hormone therapy (except oral contraceptives)
* Known allergies to fish, seafood, or any fish-derived products, including bottarga
* Pregnancy
* Clinical evidence or history of cardiac, pulmonary, hepatic, or renal insufficiency
* Immunodeficiency conditions
* History of non-skin cancer
* Participation in other clinical research studies

Primary outcomes:
measure: Mean change in fasting glucose
timeFrame: 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).
measure: Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)
timeFrame: 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).
measure: Mean Change in Hemoglobin A1c (HbA1c)
timeFrame: 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).
measure: Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C)
timeFrame: 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:
measure: Mean change in body mass index
timeFrame: 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).
measure: Mean change in body fat
timeFrame: 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).
measure: Mean change in waist circumference
timeFrame: 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).
measure: Mean change in waist/hip ratio
timeFrame: 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).
measure: Mean change in resting blood pressure
timeFrame: 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).
measure: Mean change in liver enzymes
timeFrame: 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:
Locations:
city: Sommerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
affiliation: Cambridge Health Alliance
name: Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD
role: PRINCIPAL_INVESTIGATOR
References: