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

Sponsor

University College Dublin (Other)

Overall Status

Completed

CT.gov ID

NCT01172951

Collaborator

(none)

200

Enrollment

Locations

Arms

Duration (Months)

100

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy Subjects	Other: Oral glucose tolerance test Other: Oral lipid tolerance test	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comprehensive analysis of the metabolic response to the acute ingestion of fat and glucose loads [2-5 hours post test meal ingestion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Institute for Sport and Health, University College Dublin	Dublin		Ireland	4
2	St Vincent's University Hospital	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