UC Davis Nutrition Department
Davis, California, 95616, United States
NCT Number: NCT03309982
This study will investigate the beneficial effects of supplementation with a plant polyphenol blend rich in anthocyanins on parameters of inflammation and metabolic responses following a challenge with a high-fat (HF) meal.
The investigators will use a randomized crossover study to investigate the effects of: 1) placebo (control); 2) plant polyphenol blend rich in anthocyanins; on systemic inflammatory markers (endotoxemia, cytokines, NF-κB), glucose and lipid metabolic responses following consumption of a high-fat (HF) meal in healthy subjects. The high-fat meal (320 g) consists of English muffin bread, sausage, egg and cheese, obtained from US market and completed with palm fat. The total energy content of the high-fat meal is 1,026 Kcal 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 with a total of 62% energy originated from fat, 25% from carbohydrates and 13% from protein. The high-fat meal will be standard and it will not be adjusted for large and small participants.
Looking for future studies?
Notify Me18 year–35 year
All sexes
Interventional
Not applicable
Davis, California, 95616, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure endotoxin in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-6 in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure insulin in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GLP-1 in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GLP-2 in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure GIP in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure adiponectin in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure leptin in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure ghrelin in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure triglycerides in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total cholesterol in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure HDL in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure LDL in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure zonulin in plasma
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure total catechins in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure glucose in plasma
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-8 in PBMC
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-10 in PBMC
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-1β in PBMC
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure IL-12p70 in PBMC
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure TNFa in PBMC
Time frame: Baseline, 0.5 hr, 1 hr, 2hrs, 3hrs, and 5hrs post high-fat meal consumption
blood sample collected by venipuncture to measure NF-kB in PBMC
Time frame: Baseline, and 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure triglycerides
Time frame: Baseline, and 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure total cholesterol
Time frame: Baseline, and 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure HDL
Time frame: Baseline, and 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure LDL
Time frame: Baseline, and 15 minutes post high-fat meal consumption
blood sample collected by fingerstick to measure glucose
Pharmanex
Industry
A Randomized Placebo-controlled Cross-over Design Study Investigating the Effects of a Plant Polyphenol Blend on the Intestinal Inflammatory and Metabolic Responses to a High Fat Meal in Healthy Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07024940
Anthocyanins, Coffee
St Louis, Missouri, United States
View Trial DetailsNCT07054671
Anthocyanins, Behavior
Burdur, Turkey (Türkiye)
View Trial Details