Effects of Functional Ingredients in an Acute Metabolic Challenge Context

August 20, 2019 updated by: Juscelino Tovar, Lund University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE 223 81
        • Food for Health Science Centre. Lund University Medicon Village

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 hours postprandial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 h postprandial
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.
4 hours postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Collaborators

Vinnova
Antidiabetic Food Centre AFC

Investigators

  • Study Director: Juscelino Tovar, PhD, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

December 3, 2015

First Submitted That Met QC Criteria

December 4, 2015

First Posted (Estimate)

December 7, 2015

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFC-JT-Ac.Ch

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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