Metabolic Syndrome
Conditions
Keywords
type 2 diabetes risk, cardiovascular disease risk
Brief 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.
Interventions
OTHERReference breakfast
A high fat, high calorie breakfast
OTHERActive Ingredient 1
A high fat, high calorie breakfast including the Active Ingredient 1
OTHERActive Ingredient 2
A high fat, high calorie breakfast including the Active Ingredient 2
OTHERActive Ingredient 3
A high fat, high calorie breakfast including the Active Ingredient 3
OTHERActive Ingredient 4
A high fat, high calorie breakfast including the Active Ingredient 4
Sponsors
Vinnova
Antidiabetic Food Centre AFC
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 73 Years
Healthy volunteers
Yes
Inclusion criteria
* overweight (BMI between 25 and 30) * fasting blood glucose value ≤ 6.1 mmol/l.
Exclusion criteria
* treatment for dyslipidemia * treatment for hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal | 4 hours postprandial | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal | 4 h postprandial | 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. |
| Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal | 4 hours postprandial | 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. |
Countries
Sweden
Outcome results
None listed