Nutrigenomics Investigation of the Body's Metabolic Response to 2 Different Meal Challenges (MECHE)

January 10, 2011 updated by: University College Dublin

A Nutrigenomics Study of Post-prandial Metabolic Responses in Individuals of Varying Body Weight: An Assessment of the Body's Response to Meals Containing Different Levels of Fat and Carbohydrate

The purpose of this study is to investigate the biological response to a metabolic stress, given in the form of a high carbohydrate or fat meal in normal weight, overweight and obese individuals and to further explore these responses using novel metabolomic, proteomic, transcriptomic and genotyping techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The most recent statistics from the Department of Health in Ireland (2005) indicate that the leading causes of death are those in which nutrition can play a key preventative role. The proposed study will provide information on the metabolic stress from varying body weight overlaid by the additional metabolic stress of a test-meal challenge, in this case being delivered in the form of an oral glucose tolerance test (OGTT) and oral lipid tolerance test (OLTT), standard metabolic challenges in post-prandial research. Previous studies assessing metabolic risk factors associated with a disease have typically focused on information collected from individuals in a fasting state only. However, it is equally important to assess how the body responds when stressed. Employing an acute high fat or carbohydrate intake is sufficient to induce a mild stress in which time an individual's unique post-prandial response can be monitored. This study will combine traditional markers (dietary, anthropometric, lifestyle, clinical and physical activity) with nutrigenomics, a tool that attempts to describe the genome-wide influences of nutrition by examining the impact of diet on genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics).

Study Type

Interventional

Enrollment (Anticipated)

200

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

  • Ireland
      • Dublin, Ireland, 4
        • St Vincent's University Hospital
      • Dublin, Ireland, 4
        • Institute for Sport and Health, University College Dublin

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 to 60 years
  • Not taking medication (other than contraceptive pill/HRT)
  • Irish resident and living in Dublin area

Exclusion Criteria:

  • Known chronic/infectious disease
  • Pregnancy/lactation
  • Desire to conceive or lose weight during study
  • Athlete

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OGTT-OGTT-Physical tests
2 successive Oral Glucose Tolerance Tests followed by a physical tests session
Other: Oral glucose tolerance test
75g anhydrous glucose powder mixed with 100mls water
Active Comparator: OLTT-OLTT-Physical tests
2 successive Oral Lipid Tolerance Tests followed by a physical test session
Other: Oral lipid tolerance test
150ml drink composed of 2 commercially available high fat products
Active Comparator: OGTT-OLTT-Physical tests
Oral glucose tolerance test followed by an oral lipid tolerance test (or vice-versa) followed by a physical tests session
Other: Oral glucose tolerance test
75g anhydrous glucose powder mixed with 100mls water
Other: Oral lipid tolerance test
150ml drink composed of 2 commercially available high fat products

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comprehensive analysis of the metabolic response to the acute ingestion of fat and glucose loads
Time Frame: 2-5 hours post test meal ingestion
2-5 hours post test meal ingestion

Collaborators and Investigators

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

Sponsor

University College Dublin

Investigators

  • Principal Investigator: Helen Roche, PhD, University College Dublin
  • Principal Investigator: Michael J Gibney, PhD, University College Dublin
  • Principal Investigator: Donal O'Shea, MD, St Vincent's University Hospital, Ireland
  • Principal Investigator: Eileen Gibney, PhD, University College Dublin

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

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

December 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

July 29, 2010

First Posted (Estimate)

July 30, 2010

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LS-08-43-GR
  • DAF- HRB (Ireland) (Other Grant/Funding Number: 07FHRIUCD1)

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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