NCT02623608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

December 3, 2015

Last Update Submit

August 20, 2019

Conditions

Metabolic Syndrome

Keywords

type 2 diabetes riskcardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

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

    4 h postprandial

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

    4 hours postprandial

Study Arms (5)

High fat meal

EXPERIMENTAL

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

High fat meal + Active Ingredient 1

EXPERIMENTAL

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

High fat meal + Active Ingredient 2

EXPERIMENTAL

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

High fat meal + Active Ingredient 3

EXPERIMENTAL

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

High fat meal + Active Ingredient 4

EXPERIMENTAL

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

Interventions

Reference breakfastOTHER

A high fat, high calorie breakfast

High fat meal
Active Ingredient 1OTHER

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

High fat meal + Active Ingredient 1
Active Ingredient 2OTHER

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

High fat meal + Active Ingredient 2
Active Ingredient 3OTHER

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

High fat meal + Active Ingredient 3
Active Ingredient 4OTHER

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

High fat meal + Active Ingredient 4

Eligibility Criteria

Age50 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • treatment for dyslipidemia
  • treatment for hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Food for Health Science Centre. Lund University Medicon Village

Lund, SE 223 81, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 17719342BACKGROUND

  • 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.

    PMID: 14522730BACKGROUND

  • 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.

    PMID: 24127338BACKGROUND

  • 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.

    PMID: 23847095BACKGROUND

Related Links

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Juscelino Tovar, PhD

    Lund University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Leader

Study Record Dates

First Submitted

December 3, 2015

First Posted

December 7, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

August 22, 2019

Record last verified: 2019-08

Locations

SE(1)