NCT04637945

Inflammatory and Metabolic Responses to Long-term Dietary Supplementation With Anthocyanin-rich Blend

a Randomized Placebo-controlled Study Investigating the Effects of a Long-term Dietary Supplementation With an Anthocyanin-rich Blend on the Metabolic and Inflammatory Responses to a High-fat Meal in Healthy Subjects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pharmanex · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Anthocyanins

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ACRB	Product will be consumed once daily, preferably with breakfast.
OTHER	Placebo	Product will be consumed once daily, preferably with breakfast.

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2020-11-20
• Last updated: 2022-12-21

Locations

1 site across 1 country: United States