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

This study has been completed.
Sponsor:
Information provided by:
University College Dublin
ClinicalTrials.gov Identifier:
NCT01172951
First received: July 29, 2010
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Healthy Subjects
Other: Oral glucose tolerance test
Other: Oral lipid tolerance test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University College Dublin:

Primary Outcome Measures:
  • Comprehensive analysis of the metabolic response to the acute ingestion of fat and glucose loads [ Time Frame: 2-5 hours post test meal ingestion ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01172951

Locations
Ireland
St Vincent's University Hospital
Dublin, Ireland, 4
Institute for Sport and Health, University College Dublin
Dublin, Ireland, 4
Sponsors and Collaborators
University College Dublin
Investigators
Principal Investigator: Michael J Gibney, PhD University College Dublin
Principal Investigator: Donal O'Shea, MD St Vincent's University Hospital, Ireland
Principal Investigator: Helen Roche, PhD University College Dublin
Principal Investigator: Lorraine Brennan, PhD University College Dublin
Principal Investigator: Eileen Gibney, PhD University College Dublin
  More Information

No publications provided by University College Dublin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Mike Gibney, Institute of Food and Health, University College Dublin
ClinicalTrials.gov Identifier: NCT01172951     History of Changes
Other Study ID Numbers: LS-08-43-GR, DAF- HRB (Ireland)
Study First Received: July 29, 2010
Last Updated: January 10, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University College Dublin:
Post-prandial
Nutrigenomic
Test meal
Oral glucose tolerance test
Oral lipid tolerance test

ClinicalTrials.gov processed this record on July 20, 2014