Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06988462 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion pushed from Aug 25, 2026 to Dec 25, 2026
    • Study completion pushed from Dec 1, 2026 to Mar 1, 2027
    v5
  3. Primary completion date: Nov 25, 2025 to Aug 25, 2026v4 Show 4 more changesShow less
    • Start date changed from estimate of Jun 25, 2025 to Oct 17, 2025
    • Study completion date: Jun 1, 2026 to Dec 1, 2026
    • Study description expanded, about 6 words
    • Eligibility criteria shortened, about 5 words
  4. Start date: May 30, 2025 to Jun 25, 2025v3
  5. Eligibility criteria shortened, about 2 words
    • Study description expanded, about 2 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cambridge Health Alliance
15 trials monitored
See 1 trial at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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.
Trial Details
NCT Number NCT06988462
Lead Sponsor Cambridge Health Alliance
Conditions
(from sponsor)		 Prediabetes, Diabetes, High Cholesterol/Hyperlipidemia, Obesity & Overweight, Triglycerides, HDL Cholesterol
Related terms Diabetes Mellitus, Glucose Intolerance, Hypercholesterolemia, Hyperlipidemias, Inflammation, Obesity, Overweight, Prediabetic State
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov