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

Part of paid clinical trials in Sommerville, Massachusetts.

Sponsor
Cambridge Health Alliance
Study ID
NCT06988462
Status
Recruiting
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Conditions

  • Diabetes
  • HDL Cholesterol
  • High Cholesterol/Hyperlipidemia
  • Obesity & Overweight
  • Prediabetes
  • Triglycerides

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 23, 2025
Start date
Oct 17, 2025
Status verified
Jul 2026
Primary completion
Dec 25, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Experimental: Bottarga supplementation (intervention group)
    Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be randomly allocated to 8 weeks of daily bottarga supplementation (20 grams/day; participants weighing \>100 kg \[220 lbs\] will consume 40 g/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; participants weighing \>100 kg \[220 lbs\] will consume 56 g/day), followed by final assessment measures.
  • Sham Comparator: Cream cheese supplementation (control)
    Ten participants with at least one metabolic abnormality (low HDL cholesterol, high LDL cholesterol, high triglycerides, obesity, or HbA1c ≥ 5.7%) or a diagnosis of diabetes will be 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;participants weighing \>100 kg \[220 lbs\] will consume 40 g/day), followed by final assessment measures.

Primary Outcome Measure

Mean change in fasting glucose [ 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). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cambridge Health AllianceSommervilleMassachusetts02145
Patricia Lenehan
[email protected]
617-665-1580
Stefanos N Kales, MD (PRINCIPAL_INVESTIGATOR)

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Cambridge Health Alliance· Sommerville, MA

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