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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) 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), followed by final assessment measures. |
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| 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), followed by final assessment measures. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bottarga | Other | Participants will consume prepackaged daily doses of Bottarga, each containing the required amount (20 grams/day) for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean change in fasting glucose | Mean change in fasting glucose levels (mg/dL) after overnight fast. | 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. | 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. | 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. | 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 | Description | Time Frame |
|---|---|---|
| Mean change in body mass index | Body Mass Index (kg/m-squared) | 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 |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefanos N Kales, Professor of Medicine, Harvard Medical School, MD | Cambridge Health Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cambridge Health Alliance | Recruiting | Sommerville | Massachusetts | 02145 | United States |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D003920 | Diabetes Mellitus |
| D006937 | Hypercholesterolemia |
| D006949 | Hyperlipidemias |
| D009765 | Obesity |
| D050177 | Overweight |
| D018149 | Glucose Intolerance |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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.
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| Comparator | Other | Participants will consume 28g of cream cheese/day for 8 weeks. |
|
Body fat percentage as measured by bioelectrical impedance |
| 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) | 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) | 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. | 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. | 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). |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006943 | Hyperglycemia |
| D010335 | Pathologic Processes |