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

University College Dublin

Status: Completed

Conditions: Healthy Subjects

Treatments: Other: Oral lipid tolerance test; Other: Oral glucose tolerance test

Study type: Interventional

Funder types: Other

Identifiers

NCT01172951

DAF- HRB (Ireland) (Other Grant/Funding Number)

LS-08-43-GR

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

OGTT-OGTT-Physical tests

Active Comparator group

Description:

2 successive Oral Glucose Tolerance Tests followed by a physical tests session

Treatment:

Other: Oral glucose tolerance test

OLTT-OLTT-Physical tests

Active Comparator group

Description:

2 successive Oral Lipid Tolerance Tests followed by a physical test session

Treatment:

Other: Oral lipid tolerance test

OGTT-OLTT-Physical tests

Active Comparator group

Description:

Oral glucose tolerance test followed by an oral lipid tolerance test (or vice-versa) followed by a physical tests session

Treatment:

Other: Oral lipid tolerance test

Other: Oral glucose tolerance test