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

Обзор

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.

Подробное описание

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 adults with at least one metabolic abnormality, 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 participants with at least one metabolic abnormality 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.

Вмешательства

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

Первичные конечные точки

• Mean change in fasting glucose [Срок оценки: 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).]
• Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP) [Срок оценки: 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).]
• Mean Change in Hemoglobin A1c (HbA1c) [Срок оценки: 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).]
• Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C) [Срок оценки: 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).]

Вторичные конечные точки (6)

• Mean change in body mass index [Срок оценки: 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).]
• Mean change in body fat [Срок оценки: 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).]
• Mean change in waist circumference [Срок оценки: 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).]
• Mean change in waist/hip ratio [Срок оценки: 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).]
• Mean change in resting blood pressure [Срок оценки: 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).]
• Mean change in liver enzymes [Срок оценки: 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).]

Критерии участия

• 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
• Willing to consume a nutritional supplement and comply with study procedures

Критерии исключения

• 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)
• Known allergies to fish, seafood, or any fish-derived products, including bottarga
• Pregnancy
• Clinical evidence or history of hepatic or renal insufficiency
• Immunodeficiency conditions
• History of non-skin cancer
• Participation in other clinical research studies

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Cambridge Health Alliance — Sommerville

Идентификаторы

NCT: NCT06988462 · CHA-IRB-24-25-346

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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