Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623608
• Other study ID #: AFC-JT-Ac.Ch
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2019
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 73 Years

Eligibility

Inclusion Criteria:

• overweight (BMI between 25 and 30)

• fasting blood glucose value = 6.1 mmol/l.

Exclusion Criteria:

• treatment for dyslipidemia

• treatment for hypertension

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

Other:
• Reference breakfast
A high fat, high calorie breakfast
• Active Ingredient 1
A high fat, high calorie breakfast including the Active Ingredient 1
• Active Ingredient 2
A high fat, high calorie breakfast including the Active Ingredient 2
• Active Ingredient 3
A high fat, high calorie breakfast including the Active Ingredient 3
• Active Ingredient 4
A high fat, high calorie breakfast including the Active Ingredient 4

Locations

Country	Name	City	State
Sweden	Food for Health Science Centre. Lund University Medicon Village	Lund

Sponsors (3)

Lead Sponsor	Collaborator
Lund University	Antidiabetic Food Centre AFC, Vinnova

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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. Review. — View 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. — View 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. Epub 2007 Jun 26. Review. — View Citation

Strassburg K, Esser D, Vreeken RJ, Hankemeier T, Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Food for Health Science Centre/Antidiabetic Food Centre, hosts of the study
•   Published results
•   Published results