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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Oral glucose tolerance test
* Other: Oral lipid tolerance test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-prandial, Nutrigenomic, Test meal, Oral glucose tolerance test, Oral lipid tolerance test