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

NCT ID: NCT01172951

Last Updated: 2011-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

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).

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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OGTT-OGTT-Physical tests

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

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance test

Intervention Type OTHER

75g anhydrous glucose powder mixed with 100mls water

OLTT-OLTT-Physical tests

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

Group Type ACTIVE_COMPARATOR

Oral lipid tolerance test

Intervention Type OTHER

150ml drink composed of 2 commercially available high fat products

OGTT-OLTT-Physical tests

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

Group Type ACTIVE_COMPARATOR

Oral glucose tolerance test

Intervention Type OTHER

75g anhydrous glucose powder mixed with 100mls water

Oral lipid tolerance test

Intervention Type OTHER

150ml drink composed of 2 commercially available high fat products

Interventions

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Oral glucose tolerance test

75g anhydrous glucose powder mixed with 100mls water

Intervention Type OTHER

Oral lipid tolerance test

150ml drink composed of 2 commercially available high fat products

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Institute of Food and Health, University College Dublin

Principal Investigators

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Michael J Gibney, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Donal O'Shea, MD

Role: PRINCIPAL_INVESTIGATOR

St Vincent's University Hospital, Ireland

Helen Roche, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Lorraine Brennan, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Eileen Gibney, PhD

Role: PRINCIPAL_INVESTIGATOR

University College Dublin

Locations

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Institute for Sport and Health, University College Dublin

Dublin, , Ireland

Site Status

St Vincent's University Hospital

Dublin, , Ireland

Site Status

Countries

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Ireland

References

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Jackson KG, Li Y, Ryan MF, Gibney ER, Brennan L, Roche HM, Williams CM, Lovegrove JA, Vimaleswaran KS. Association of the tumor necrosis factor-alpha promoter polymorphism with change in triacylglycerol response to sequential meals. Nutr J. 2016 Jul 25;15(1):70. doi: 10.1186/s12937-016-0190-9.

Reference Type DERIVED
PMID: 27456841 (View on PubMed)

Matone A, O'Grada CM, Dillon ET, Morris C, Ryan MF, Walsh M, Gibney ER, Brennan L, Gibney MJ, Morine MJ, Roche HM. Body mass index mediates inflammatory response to acute dietary challenges. Mol Nutr Food Res. 2015 Nov;59(11):2279-92. doi: 10.1002/mnfr.201500184. Epub 2015 Sep 22.

Reference Type DERIVED
PMID: 26314729 (View on PubMed)

Morris C, O'Grada CM, Ryan MF, Gibney MJ, Roche HM, Gibney ER, Brennan L. Modulation of the lipidomic profile due to a lipid challenge and fitness level: a postprandial study. Lipids Health Dis. 2015 Jul 1;14:65. doi: 10.1186/s12944-015-0062-x.

Reference Type DERIVED
PMID: 26123789 (View on PubMed)

Ferguson JF, Ryan MF, Gibney ER, Brennan L, Roche HM, Reilly MP. Dietary isoflavone intake is associated with evoked responses to inflammatory cardiometabolic stimuli and improved glucose homeostasis in healthy volunteers. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):996-1003. doi: 10.1016/j.numecd.2014.03.010. Epub 2014 Apr 18.

Reference Type DERIVED
PMID: 24875672 (View on PubMed)

Wallace M, Morris C, O'Grada CM, Ryan M, Dillon ET, Coleman E, Gibney ER, Gibney MJ, Roche HM, Brennan L. Relationship between the lipidome, inflammatory markers and insulin resistance. Mol Biosyst. 2014 Jun;10(6):1586-95. doi: 10.1039/c3mb70529c. Epub 2014 Apr 9.

Reference Type DERIVED
PMID: 24714806 (View on PubMed)

Morris C, Grada CO, Ryan M, Roche HM, De Vito G, Gibney MJ, Gibney ER, Brennan L. The relationship between aerobic fitness level and metabolic profiles in healthy adults. Mol Nutr Food Res. 2013 Jul;57(7):1246-54. doi: 10.1002/mnfr.201200629. Epub 2013 Mar 15.

Reference Type DERIVED
PMID: 23505034 (View on PubMed)

Ryan MF, O'Grada CM, Morris C, Segurado R, Walsh MC, Gibney ER, Brennan L, Roche HM, Gibney MJ. Within-person variation in the postprandial lipemic response of healthy adults. Am J Clin Nutr. 2013 Feb;97(2):261-7. doi: 10.3945/ajcn.112.047936. Epub 2013 Jan 2.

Reference Type DERIVED
PMID: 23283501 (View on PubMed)

Morris C, O'Grada C, Ryan M, Roche HM, Gibney MJ, Gibney ER, Brennan L. The relationship between BMI and metabolomic profiles: a focus on amino acids. Proc Nutr Soc. 2012 Nov;71(4):634-8. doi: 10.1017/S0029665112000699. Epub 2012 Aug 6.

Reference Type DERIVED
PMID: 22863201 (View on PubMed)

Other Identifiers

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DAF- HRB (Ireland)

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

LS-08-43-GR

Identifier Type: -

Identifier Source: org_study_id

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