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

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Oral glucose tolerance test; Other: Oral lipid tolerance test

• Registration Number: NCT01172951
• Lead Sponsor: University College Dublin

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.

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-07-29
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-10
• Last Update Posted: 2011-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OGTT-OGTT-Physical tests	Oral glucose tolerance test	2 successive Oral Glucose Tolerance Tests followed by a physical tests session
OLTT-OLTT-Physical tests	Oral lipid tolerance test	2 successive Oral Lipid Tolerance Tests followed by a physical test session
OGTT-OLTT-Physical tests	Oral glucose tolerance test	Oral glucose tolerance test followed by an oral lipid tolerance test (or vice-versa) followed by a physical tests session
OGTT-OLTT-Physical tests	Oral lipid tolerance test	Oral glucose tolerance test followed by an oral lipid tolerance test (or vice-versa) followed by a physical tests session

Primary Outcome Measures

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

Trial Locations

Locations (2)

Institute for Sport and Health, University College Dublin; 🇮🇪 Dublin, Ireland

St Vincent's University Hospital; 🇮🇪 Dublin, Ireland