NCT02623608

Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Acute Metabolic Challenge for the Assessment of Cardiometabolic Protective Effects of Foods

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Lund University · Academic / Other
• Sex: All
• Age: 50 Years – 73 Years
• Healthy volunteers: Accepted

Summary

After an energy-rich meal the blood levels of glucose and lipids undergo a marked temporary increase, triggering a wave of oxidative stress due to the appearance of excess free radicals in adipose and muscle tissues. Elevated postprandial hypertriglyceridemia has been associated with increased risk of cardiovascular disease and type 2 diabetes. Hence, postprandial changes in different circulating biomarkers are potential predictors of cardiometabolic risk. In addition to the possibility of evaluating acute variations in metabolic risk markers in response to different types of fat, the metabolic challenge approach may serve as a challenge-meal background in order to reveal possible beneficial effects of specific food ingredients. In this study, circulating cardiometabolic disease-related biomarkers, including endotoxemia, will be assessed postprandially in search for beneficial actions of particular functional food ingredients consumed in combination with a high-fat meal.

Detailed description

The study will be carried out in a group of healthy mature subjects with overweight and normal fasting blood glucose values. A randomized crossover design will be followed, in which the postprandial metabolic responses to a high fat breakfast (HF) will be compared with those registered after an identical breakfast containing a functional ("active") ingredient. Each meal will be tested in an independent experimental session. Experimental sessions will take place with1 week interval. The study will be carried out at the Food for Health Laboratory, Food for Health Science Centre - Lund University (Medicon Village, Lund). The volunteers will consume the challenge HF alone and with 4 active ingredients, i.e. each volunteer will undergo five experimental sessions. Additionally, the plan contemplates an initial information visit that includes the screening of fasting blood glucose. In total, each volunteer completing the study will pay six visits to the Food for Health Laboratory. Based on the results from the above-described phase, a second step of the study will focus on the impact of the order of consumption -i.e. "active ingredient" before HF and vice versa on cardiometabolic risk outcomes, as a way to optimize putative protective actions.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
OTHER	Reference breakfast	A high fat, high calorie breakfast
OTHER	Active Ingredient 1	A high fat, high calorie breakfast including the Active Ingredient 1
OTHER	Active Ingredient 2	A high fat, high calorie breakfast including the Active Ingredient 2
OTHER	Active Ingredient 3	A high fat, high calorie breakfast including the Active Ingredient 3
OTHER	Active Ingredient 4	A high fat, high calorie breakfast including the Active Ingredient 4

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-01-01
• Completion: 2016-07-01
• First posted: 2015-12-07
• Last updated: 2019-08-22

Locations

1 site across 1 country: Sweden