Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Other: Reference breakfast
* Other: Active Ingredient 1
* Other: Active Ingredient 2
* Other: Active Ingredient 3
* Other: Active Ingredient 4


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight (BMI between 25 and 30) fasting blood glucose value ≤ 6.1 mmol/l. Exclusion Criteria: treatment for dyslipidemia treatment for hypertension

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High fat meal<br>Subjects eat a high fat breakfast (reference breakfast) at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h. | Other: Reference breakfast<br>* A high fat, high calorie breakfast<br>|
| Experimental: High fat meal + Active Ingredient 1<br>Subjects eat the same high fat breakfast with the active ingredient 1 at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h. | Other: Active Ingredient 1<br>* A high fat, high calorie breakfast including the Active Ingredient 1<br>|
| Experimental: High fat meal + Active Ingredient 2<br>Subjects eat the same high fat breakfast with the active ingredient 2 at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h. | Other: Active Ingredient 2<br>* A high fat, high calorie breakfast including the Active Ingredient 2<br>|
| Experimental: High fat meal + Active Ingredient 3<br>Subjects eat the same high fat breakfast with the active ingredient 3 at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h. | Other: Active Ingredient 3<br>* A high fat, high calorie breakfast including the Active Ingredient 3<br>|
| Experimental: High fat meal + Active Ingredient 4<br>Subjects eat the same high fat breakfast with the active ingredient 4 at 7:30 am. The meal contains 50 g fat and 900 kcal. Blood samples are taken before the breakfast and every 30 min postprandial for 4 h. | Other: Active Ingredient 4<br>* A high fat, high calorie breakfast including the Active Ingredient 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal | plasma triglycerides are measured pre-meal and at various post-meal intervals for up to for 4 hours. The area under curve (AUC) is calculated and compared to AUC following the reference meal. | 4 hours postprandial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal | plasma LPS is measured pre-meal and and at various post-meal intervals for up to for 4 hours. AUC is calculated and compared to AUC recorded for the reference meal. | 4 h postprandial | 
| Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal | plasma glucose is measured pre-meal and and at various post-meal intervals for up to for 4 hours. AUC is calculated and compared to AUC recorded after the reference meal. | 4 hours postprandial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 2 diabetes risk, cardiovascular disease risk