CClinicalTrials.gg
CompletedNCT01172951MECHEUpdated Jan 11, 2011

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

An interventional study of Oral glucose tolerance test and Oral lipid tolerance test in Healthy Subjects, sponsored by University College Dublin. Completed at 2 sites in Ireland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-11.

Sponsored by University College Dublin · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Healthy Subjects

Keywords

  • Post-prandial
  • Nutrigenomic
  • Test meal
  • Oral glucose tolerance test
  • Oral lipid tolerance test
03

In context

Lead sponsor

University College Dublin is the lead sponsor of 108 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

Exclusion Criteria:

  • Known chronic/infectious disease
  • Pregnancy/lactation
  • Desire to conceive or lose weight during study
  • Athlete
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    OGTT-OGTT-Physical tests

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

    Other: Oral glucose tolerance test

  • Active comparator
    OLTT-OLTT-Physical tests

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

    Other: Oral lipid tolerance test

  • 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 · Other: Oral lipid tolerance test

Interventions

  • OtherOral glucose tolerance test

    75g anhydrous glucose powder mixed with 100mls water

  • OtherOral lipid tolerance test

    150ml drink composed of 2 commercially available high fat products

06

What researchers measure

Primary outcomes

  1. Comprehensive analysis of the metabolic response to the acute ingestion of fat and glucose loads

    Time frame: 2-5 hours post test meal ingestion

07

Study locations

2 sites
  • Institute for Sport and Health, University College Dublin
    Dublin, 4, Ireland
  • St Vincent's University Hospital
    Dublin, 4, Ireland
08

References and documents

Publications

  • 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. PubMed 27456841 ↗
  • 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. PubMed 26314729 ↗
  • 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. PubMed 26123789 ↗
  • 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. PubMed 24875672 ↗
  • 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. PubMed 24714806 ↗
  • 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. PubMed 23505034 ↗
  • 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. Erratum In: Am J Clin Nutr. 2014 Oct;100(4):1214. Grada, Colm O [corrected to O'Grada, Colm M]. PubMed 23283501 ↗
  • 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. PubMed 22863201 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01172951
Lead sponsor
University College Dublin
First posted
Jul 30, 2010
Start date
Dec 2008
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jan 11, 2011

Study contacts

Michael J Gibney, PhD
principal investigator · University College Dublin
Donal O'Shea, MD
principal investigator · St Vincent's University Hospital, Ireland
Helen Roche, PhD
principal investigator · University College Dublin
Lorraine Brennan, PhD
principal investigator · University College Dublin
Eileen Gibney, PhD
principal investigator · University College Dublin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion