Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Other: Reference breakfast; Other: Active Ingredient 1; Other: Active Ingredient 2; Other: Active Ingredient 3; Other: Active Ingredient 4

• Registration Number: NCT02623608
• Lead Sponsor: Lund University

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-07
• Primary Completion: 2016-01
• Study Completion: 2016-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

• treatment for dyslipidemia
• treatment for hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High fat meal	Reference breakfast	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.
High fat meal + Active Ingredient 1	Active Ingredient 1	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.
High fat meal + Active Ingredient 2	Active Ingredient 2	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.
High fat meal + Active Ingredient 3	Active Ingredient 3	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.
High fat meal + Active Ingredient 4	Active Ingredient 4	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Food for Health Science Centre. Lund University Medicon Village; 🇸🇪 Lund, Sweden