Clinical trial NCT02623608: Effects of Functional Ingredients in an Acute Metabolic Challenge Context
Official title: Acute Metabolic Challenge for the Assessment of Cardiometabolic Protective Effects of Foods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: type 2 diabetes risk
cardiovascular disease risk
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Vinnova
name: Antidiabetic Food Centre AFC
First posted: 2015-12-07
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* overweight (BMI between 25 and 30)
* fasting blood glucose value ≤ 6.1 mmol/l.

Exclusion Criteria:

* treatment for dyslipidemia
* treatment for hypertension

Primary outcomes:
measure: Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
timeFrame: 4 hours postprandial
Secondary outcomes:
measure: AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal
timeFrame: 4 h postprandial
measure: Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal
timeFrame: 4 hours postprandial
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Food for Health Science Centre. Lund University Medicon Village
Study officials:
affiliation: Lund University
name: Juscelino Tovar, PhD
role: STUDY_DIRECTOR
References:
citation: O'Keefe JH, Bell DS. Postprandial hyperglycemia/hyperlipidemia (postprandial dysmetabolism) is a cardiovascular risk factor. Am J Cardiol. 2007 Sep 1;100(5):899-904. doi: 10.1016/j.amjcard.2007.03.107. Epub 2007 Jun 26.
citation: Johnston KL, Clifford MN, Morgan LM. Coffee acutely modifies gastrointestinal hormone secretion and glucose tolerance in humans: glycemic effects of chlorogenic acid and caffeine. Am J Clin Nutr. 2003 Oct;78(4):728-33. doi: 10.1093/ajcn/78.4.728.
citation: Strassburg K, Esser D, Vreeken RJ, Hankemeier T, Muller M, van Duynhoven J, van Golde J, van Dijk SJ, Afman LA, Jacobs DM. Postprandial fatty acid specific changes in circulating oxylipins in lean and obese men after high-fat challenge tests. Mol Nutr Food Res. 2014 Mar;58(3):591-600. doi: 10.1002/mnfr.201300321. Epub 2013 Oct 14.
citation: Herieka M, Erridge C. High-fat meal induced postprandial inflammation. Mol Nutr Food Res. 2014 Jan;58(1):136-46. doi: 10.1002/mnfr.201300104. Epub 2013 Jul 12.