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Completed

NCT Number: NCT02623608

Effects of Functional Ingredients in an Acute Metabolic Challenge Context

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year–73 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Food for Health Science Centre. Lund University Medicon Village

Lund, SE 223 81, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • treatment for dyslipidemia
  • treatment for hypertension

Treatment and study plan

Reference breakfast

Other

A high fat, high calorie breakfast

Active Ingredient 1

Other

A high fat, high calorie breakfast including the Active Ingredient 1

Active Ingredient 2

Other

A high fat, high calorie breakfast including the Active Ingredient 2

Active Ingredient 3

Other

A high fat, high calorie breakfast including the Active Ingredient 3

Active Ingredient 4

Other

A high fat, high calorie breakfast including the Active Ingredient 4

Primary outcomes

  1. Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal

    Time frame: 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 outcomes

  1. AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal

    Time frame: 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.

  2. Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lund University

Other

Collaborators

  • Antidiabetic Food Centre AFC
  • Vinnova

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2015
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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