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Trial record 8 of 755 for:    Area Under Curve AND meal

Effects of Functional Ingredients in an Acute Metabolic Challenge Context

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ClinicalTrials.gov Identifier: NCT02623608
Recruitment Status : Completed
First Posted : December 7, 2015
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
Vinnova
Antidiabetic Food Centre AFC
Information provided by (Responsible Party):
Juscelino Tovar, 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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Other: Reference breakfast Other: Active Ingredient 1 Other: Active Ingredient 2 Other: Active Ingredient 3 Other: Active Ingredient 4 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acute Metabolic Challenge for the Assessment of Cardiometabolic Protective Effects of Foods
Study Start Date : August 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: High fat meal
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.
Other: Reference breakfast
A high fat, high calorie breakfast

Experimental: High fat meal + 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.
Other: Active Ingredient 1
A high fat, high calorie breakfast including the Active Ingredient 1

Experimental: High fat meal + 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.
Other: Active Ingredient 2
A high fat, high calorie breakfast including the Active Ingredient 2

Experimental: High fat meal + 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.
Other: Active Ingredient 3
A high fat, high calorie breakfast including the Active Ingredient 3

Experimental: High fat meal + 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.
Other: Active Ingredient 4
A high fat, high calorie breakfast including the Active Ingredient 4




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623608


Locations
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Sweden
Food for Health Science Centre. Lund University Medicon Village
Lund, Sweden, SE 223 81
Sponsors and Collaborators
Lund University
Vinnova
Antidiabetic Food Centre AFC
Investigators
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Study Director: Juscelino Tovar, PhD Lund University

Additional Information:
Publications:
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Responsible Party: Juscelino Tovar, Project Leader, Lund University
ClinicalTrials.gov Identifier: NCT02623608     History of Changes
Other Study ID Numbers: AFC-JT-Ac.Ch
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Keywords provided by Juscelino Tovar, Lund University:
type 2 diabetes risk
cardiovascular disease risk
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases