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This study will investigate the capacity of an anthocyanin-rich blend (ACRB) dietary supplement to improve the alterations in lipid and glucose homeostasis triggered by consumption of a high-fat meal. Given the impact of Western style diets and obesity on the development of type 2 diabetes, cardiovascular disease and other pathologies, this study has major public health implications.
In particular, this study will investigate the beneficial effects of long-term (8 weeks) supplementation with ACRB on fasting and postprandial levels of plasma triglycerides, as well as other parameters of lipid and glucose homeostasis and inflammation. Postprandial changes will be evaluated after consumption of a high-fat meal.
Subjects will receive either a: i) placebo (control),or ii) ACRB product for 8 weeks. At the beginning and at the end of the 8-week period, subjects will be submitted to a metabolic challenge consisting of consuming a high-fat meal after receiving the study product (placebo, ACRB). The high-fat meal will consist of English muffin bread, sausage, egg and cheese, obtained from US market with carotenoid-free palm oil added to bring the total dietary fat to the desired level. The total weight of the high-fat meal will be 320 g with 70.5 g of fat (29.8 g of saturated fat), 270 mg of cholesterol, 65 g carbohydrate, 5.2 g sugar, and 33 g protein. The total energy content of the high-fat meal will be 1,026 Kcal with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. Blood will be taken by venipuncture before (baseline, 0 h) and 0.25, 0.5, 1, 2, 3 and 5 h after consumption of both the high-fat meal and the study product. Plasma will be collected and chylomicrons and peripheral blood monocytes (PBMCs) will be isolated. Blood pressure and skin carotenoid content will be measured. Subjects will be also asked to collect feces before starting and at the end of the 8 week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | The placebo will be delivered in softgels consisting of colorant, olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, glycerin and water. |
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| ACRB | Experimental | The ACRB product will be delivered in softgels consisting of anthocyanin-rich blend. Each softgel will contain: i) 49 mg bilberry extract; ii) 101 mg black currant extract; and iii) 303 mg black rice extract. The high ACRB will deliver at least 108 mg anthocyanins. The product will also contain olive oil, sunflower lecithin, yellow beeswax, bovine gelatin, and water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRB | Dietary Supplement | Product will be consumed once daily, preferably with breakfast. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma triglycerides at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure triglycerides in plasma | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure plasma free fatty acids in plasma | Baseline, 8 weeks |
| Change from baseline in total free fatty acids at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Oteiza, PhD | UC Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Nutrition Department | Davis | California | 95616 | United States |
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| Placebo |
| Other |
Product will be consumed once daily, preferably with breakfast. |
|
blood sample collected by venipuncture to measure total free fatty acids in plasma |
| Baseline, 8 weeks |
| Change from baseline in HDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure HDL in plasma | Baseline, 8 weeks |
| Change from baseline in LDL at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure LDL in plasma | Baseline, 8 weeks |
| Change from baseline in glucose at week 8, both at fasting and at week 8, both at fasting and at 0.25hr, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure glucose in plasma | Baseline, 8 weeks |
| Change from baseline in insulin at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure insulin in plasma | Baseline, 8 weeks |
| Change from baseline in LPS at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure LPS in plasma | Baseline, 8 weeks |
| Change from baseline in LPS binding protein at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure LPS binding protein in plasma | Baseline, 8 weeks |
| Change from baseline in insulin resistance at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure insulin resistance in PBMCs | Baseline, 8 weeks |
| Change from baseline in PBMC gene expression at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to isolate RNA and measure gene expression in PBMCs. The most significantly differentially expressed transcripts will be chosen for further analysis. | Baseline, 8 weeks |
| Change from baseline in plasma total polyphenols at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure total polyphenols in plasma | Baseline, 8 weeks |
| Change from baseline in plasma total anthocyanidins at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure total anthycyanidins in plasma | Baseline, 8 weeks |
| Change from baseline in plasma Irisin at week 8, both at fasting and at 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to measure Irisin in plasma | Baseline, 8 weeks |
| Change from baseline in total blood gene expression at week 8, both at fasting and at 3hrs, and 5hrs post high-fat meal consumption | blood sample collected by venipuncture to isolate RNA and measure gene expression in whole blood. The most significantly deferentially expressed transcripts will be chosen for further analysis. | Baseline, 8 weeks |
| Change from baseline in blood pressure at week 8, both at fasting and at 1hrs, 2hrs, 3hrs, 4hrs, and 5hrs post high-fat meal consumption | blood pressure measured by sphygmomanometer | Baseline, 8 weeks |
| Change from baseline in fecal microbiota composition at week 8 | stool sample collected to measure gut microbiota composition using 16S rRNA gene sequences | Baseline, 8 weeks |
| Change from baseline in fecal short chain fatty acids at week 8 | stool sample collected to measure fecal short chain fatty acids | Baseline, 8 weeks |
| Change from baseline in skin carotenoids at week 4, and week 8 | skin carotenoid scanner will be used to produce a raman score of skin carotenoids | baseline, 4 weeks, 8 weeks |