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Effects of Functional Ingredients in an Acute Metabolic Challenge Context

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Reference breakfast
Active Ingredient 1
Active Ingredient 2
Active Ingredient 3
Active Ingredient 4
Sponsored by
Lund University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring type 2 diabetes risk, cardiovascular disease risk

Eligibility Criteria

50 Years - 73 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • treatment for dyslipidemia
  • treatment for hypertension

Sites / Locations

  • Food for Health Science Centre. Lund University Medicon Village

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

High fat meal

High fat meal + Active Ingredient 1

High fat meal + Active Ingredient 2

High fat meal + Active Ingredient 3

High fat meal + Active Ingredient 4

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 3, 2015
Last Updated
August 20, 2019
Sponsor
Lund University
Collaborators
Vinnova, Antidiabetic Food Centre AFC
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1. Study Identification

Unique Protocol Identification Number
NCT02623608
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lund University
Collaborators
Vinnova, Antidiabetic Food Centre AFC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
type 2 diabetes risk, cardiovascular disease risk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High fat meal
Arm Type
Experimental
Arm Description
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.
Arm Title
High fat meal + Active Ingredient 1
Arm Type
Experimental
Arm Description
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.
Arm Title
High fat meal + Active Ingredient 2
Arm Type
Experimental
Arm Description
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.
Arm Title
High fat meal + Active Ingredient 3
Arm Type
Experimental
Arm Description
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.
Arm Title
High fat meal + Active Ingredient 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reference breakfast
Intervention Description
A high fat, high calorie breakfast
Intervention Type
Other
Intervention Name(s)
Active Ingredient 1
Intervention Description
A high fat, high calorie breakfast including the Active Ingredient 1
Intervention Type
Other
Intervention Name(s)
Active Ingredient 2
Intervention Description
A high fat, high calorie breakfast including the Active Ingredient 2
Intervention Type
Other
Intervention Name(s)
Active Ingredient 3
Intervention Description
A high fat, high calorie breakfast including the Active Ingredient 3
Intervention Type
Other
Intervention Name(s)
Active Ingredient 4
Intervention Description
A high fat, high calorie breakfast including the Active Ingredient 4
Primary Outcome Measure Information:
Title
Area under the curve (AUC) of postprandial triglyceridemia (0-4h) after each intervention, compared to the reference meal
Description
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.
Time Frame
4 hours postprandial
Secondary Outcome Measure Information:
Title
AUC of postprandial endotoxemia, i.e. lipopolysaccharide (LPS) concentrations (0-4h) after each intervention, compared to the reference meal
Description
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.
Time Frame
4 h postprandial
Title
Area under the curve of postprandial glycemia (0-4h) after each intervention, compared to the reference meal
Description
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.
Time Frame
4 hours postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
73 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juscelino Tovar, PhD
Organizational Affiliation
Lund University
Official's Role
Study Director
Facility Information:
Facility Name
Food for Health Science Centre. Lund University Medicon Village
City
Lund
ZIP/Postal Code
SE 223 81
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
17719342
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.
Results Reference
background
PubMed Identifier
14522730
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.
Results Reference
background
PubMed Identifier
24127338
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.
Results Reference
background
PubMed Identifier
23847095
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.
Results Reference
background
Links:
URL
https://portal.research.lu.se/portal/en/projects/antidiabetic-food-centre(3a9bae87-b64a-49f5-97a4-868a8bb776ae).html
Description
Food for Health Science Centre/Antidiabetic Food Centre, hosts of the study
URL
https://doi.org/10.1016/j.jff.2017.09.019
Description
Published results
URL
https://doi.org/10.1016/j.jff.2019.103443
Description
Published results

Learn more about this trial

Effects of Functional Ingredients in an Acute Metabolic Challenge Context

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