PrediabetesNCT06988462
Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
A study testing Bottarga and Comparator in people with Prediabetes and Diabetes, run by Cambridge Health Alliance at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Prediabetes, Diabetes, High Cholesterol/Hyperlipidemia
- What is being tested?
- Bottarga and Comparator
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 10Show fewer
- Clinical evidence or history of hepatic or renal insufficiency
- Immunodeficiency conditions
- History of non-skin cancer
- Participation in other clinical research studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cambridge Health Alliance
Sommerville, Massachusetts, 02145
Patricia Lenehan, 617-665-1580, elidoriki@challiance.org
Stefanos N Kales, MD
About this study
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.
Read the 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 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.
- Conditions
- Prediabetes, Diabetes, High Cholesterol/Hyperlipidemia, Obesity & Overweight, Triglycerides, HDL Cholesterol
- Being tested
- Bottarga, Comparator
- Keywords
- Bottarga, pre diabetes, inflammation, sustainability, nutritional intervention, overweight, metabolic abnormalities, lipid profile, diabetes
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Hypercholesterolemia, Hyperlipidemias, Obesity, Overweight, Glucose Intolerance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BottargaOther
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.
ComparatorOther
Participants will consume 28g of cream cheese/day (participants weighing >100 kg [220 lbs] will consume 56 g/day) for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bottarga supplementation (intervention group) | Experimental | 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. Receives: Other: Bottarga |
| Cream cheese supplementation (control) | Sham comparator | 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. Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in fasting glucose
Mean change in fasting glucose levels (mg/dL) after overnight fast.
Measured: 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)
Mean change in serum hs-CRP levels (mg/L) after overnight fast.
Measured: 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)
Mean change in HbA1c levels (%) after overnight fast.
Measured: 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)
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.
Measured: 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 (6)
Mean change in body mass index
Body Mass Index (kg/m-squared)
Measured: 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
Body fat percentage as measured by bioelectrical impedance
Measured: 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
Waist circumference (cm)
Measured: 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
Waist/hip ratio (waist circumference (cm) divided by hip circumference (cm)
Measured: 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
Resting systolic and diastolic blood pressure (mmHg), measured using calibrated automated sphygmomanometers.
Measured: 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
Aspartate aminotransferase (AST, U/L), Alanine aminotransferase (ALT, U/L), Alkaline phosphatase (ALP, U/L) after overnight fast.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start17 Oct 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 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. Each intervention will last 8 weeks, separated by a 2-week washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06988462
- Sponsor's protocol ID
- CHA-IRB-24-25-346
- Status last verified
- Jul 2026
- First submitted
- 16 May 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of "Bottarga" Supplementation: A Little-known, Sustainable "Blue" Food
- ClinicalTrials.gov ID
- NCT06988462
- Acronym / sponsor ID
- CHA-IRB-24-25-346
- Conditions
- Prediabetes, Diabetes, High Cholesterol/Hyperlipidemia, Obesity & Overweight, Triglycerides, HDL Cholesterol
- Keywords
- Bottarga, pre diabetes, inflammation, sustainability, nutritional intervention, overweight, metabolic abnormalities, lipid profile
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 17 Oct 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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 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. Each intervention will last 8 weeks, separated by a 2-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Bottarga supplementation (intervention group) | Experimental | Other: BottargaTen 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. |
| Cream cheese supplementation (control) | Sham comparator | Other: ComparatorTen 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BottargaParticipants 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. | Other | Bottarga supplementation (intervention group) |
| ComparatorParticipants will consume 28g of cream cheese/day (participants weighing >100 kg [220 lbs] will consume 56 g/day) for 8 weeks. | Other | Cream cheese supplementation (control) |
Primary outcome
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).
Mean change in fasting glucose levels (mg/dL) after overnight fast.
Mean Change in High-Sensitivity C-Reactive Protein (hs-CRP)
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).
Mean change in serum hs-CRP levels (mg/L) after overnight fast.
Mean Change in Hemoglobin A1c (HbA1c)
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).
Mean change in HbA1c levels (%) after overnight fast.
Mean Change in Lipid Profile (Total Cholesterol, Triglycerides, HDL-C, LDL-C)
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).
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.
6 secondary outcomes
Mean change in body mass index
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).
Mean change in body fat
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).
Mean change in waist circumference
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).
Mean change in waist/hip ratio
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).
Mean change in resting blood pressure
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).
Mean change in liver enzymes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD principal investigator
Cambridge Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottarga and Comparator in people with Prediabetes and Diabetes, run by Cambridge Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.