NCT02039596

Brief Summary

In the post-genomic era, a major challenge for health research is to understand the complex interactions among genetic, environmental and lifestyle factors including dietary intake. Unfortunately, such initiatives are hampered by the lack of accurate dietary intake assessment methods for large studies. The newly emerging field of metabolomics offers unique possibilities to characterize individual food intake, dietary patterns and effects of dietary intervention in large studies. The investigators propose to develop a platform to detect broad metabolomic responses to food intake in controlled trials as well as to use targeted metabolomics approaches to characterize dietary intake in longitudinal studies. Our laboratory has a long history of developing methodology for assessing nutritional status and effects of diet on metabolism. Here, the investigators team up with the Sahlgrenska Academy Core Facility and the Swedish NMR Centre at the University of Gothenburg, that offer modern metabolomics equipment and competence in bioinformatics, and use this in the context of nutrition research. To their knowledge, the investigators are among the first groups in the country to develop skills in metabolomics to assess dietary intake and effects of nutrition on metabolism, and probably the first to use two complementary platforms with both mass-spectrometry and nuclear magnetic spectroscopy. Hence, our methodological results should be useful to nutritional scientists nationally as well as internationally.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

December 17, 2013

Last Update Submit

January 16, 2014

Conditions

Nutrition DisordersMetabolic Disorders

Outcome Measures

Primary Outcomes (1)

  • Acute metabolomic response

    The acute metabolomic response (ie all metabolites) to a test meal will be analyzed using both nuclear magnetic resonance (NMR) and mass spectrometry (MS) techniques. Patterns of metabolites will be evaluated with statistical techniques, ie discriminant analysis and principal component analysis.

    Directly after ingestion of test meal

Study Arms (5)

vegetarian breakfast

EXPERIMENTAL

Diet: Vegetarian food items

Other: Diet

Swedish Breakfast

EXPERIMENTAL

Diet: Swedish food items

Other: Diet

English breakfast

EXPERIMENTAL

Diet: English food items

Other: Diet

Lacto-vegetarian breakfast

EXPERIMENTAL

Diet: Lacto-vegetarian food items

Other: Diet

Swedish omnivore breakfast

EXPERIMENTAL

Diet: Swedish breakfast with meat items

Other: Diet

Interventions

DietOTHER
English breakfastLacto-vegetarian breakfastSwedish BreakfastSwedish omnivore breakfastvegetarian breakfast

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index 18.5-30.0
  • Age 18-65 years old

You may not qualify if:

  • Medications or tobacco use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Internal Medicine and Clinical Nutrition, Univ of Gothenburg

Gothenburg, S-40530, Sweden

Location

Related Publications (1)

  • Radjursoga M, Lindqvist HM, Pedersen A, Karlsson GB, Malmodin D, Brunius C, Ellegard L, Winkvist A. The 1H NMR serum metabolomics response to a two meal challenge: a cross-over dietary intervention study in healthy human volunteers. Nutr J. 2019 Apr 8;18(1):25. doi: 10.1186/s12937-019-0446-2.

    PMID: 30961592DERIVED

MeSH Terms

Conditions

Nutrition DisordersMetabolic Diseases

Interventions

Diet

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Anna K Winkvist, PhD

    Univ of Gothenburg, Sweden

    PRINCIPAL INVESTIGATOR

  • Lars H Ellegard, PhD, MD

    Univ of Gothenburg

    STUDY CHAIR

  • Helen M Lindqvist, PhD

    Univ of Gothenburg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

January 17, 2014

Study Start

September 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

SE(1)