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Completed

NCT Number: NCT03305718

Biomarkers of Meats and Potatoes Intake.

The discovery of biomarkers for the intake of meats and potatoes is needed for an accurate assessment of the intake of these foods. Twelve healthy subjects were enrolled in a controlled, cross-over meal study, randomized by a Latin square design. The test meals contained 1) beef, pork, chicken and a control meal for the meats and 2) french fries, boiled potatoes, chips and a control for the potato meals. A standardized diet was provided during sample collection. Blood and urine samples were collected up to 48h primarily for untargeted metabolomic profiling. Blood was further collected to study the effect of the meals on insulin and glycemic responses. Effects on satiety were measured by VAS and an ad libitum lunch following the test meals.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Protein-rich diets improve body weight regulations and are thus believed to play a key role in combating the global obesity epidemic. Protein-rich diets are generally high in meats, some of which have become controverted enough to be considered disease-promoting foods despite their nutritional richness. The degree at which associations with disease differs from causality is however not entirely known.

Assessment of food intake currently relies on food frequency questionnaires (FFQ), 24h recall and dietary records, all of which are self-reporting methods known to be subject to bias and inaccuracy. Biomarkers of food intake emerged thus within the past years to complement the conventional tools as objective measurements of food intake, drawn from biological samples. Several biomarkers of meat consumption have been proposed, however none is currently accepted and used as biomarker(s) of meat intake and none is able to differentiate between the different types of meat.

In the modern diet, meats are very often served with potatoes. To our knowledge, biomarkers of potato intake have not been thoroughly reported in the literature. Different cooking methods were shown to potentially influence the content of bioactive constituents of vegetables, their glycemic index, as well as subsequent energy intake. High heat cooking additionally yields the formation of potentially toxic compounds such as advanced glycation endproducts (AGEs) that were shown to contribute to insulin resistance and type 2 diabetes. In this line, biomarkers of potatoes as such as well as biomarkers to differentiate between different cooking methods would be of great importance in advancing the understanding of nutritional science.

Primary objectives:

  • To identify acute biomarkers of general meat intake by untargeted metabolomics
  • To explore the changes in the metabolome as a result of acute exposure to three types of meat and identify meat-specific biomarkers of intake
  • To identify biomarkers of acute potato intake by untargeted metabolomics
  • To identify biomarkers that can differentiate between three types of cooking methods
  • To investigate the effect of the interaction between meat on potatoes on satiety, assessed by registration of intake from an ad libitum meal

Secondary objectives:

  • To validate already known biomarkers of meat intake by targeted metabolomics
  • To investigate the effect of the interaction between meat and potatoes on satiety, assessed by visual analogue scales
  • To investigate the effect of the interaction between meat and potatoes on glucose and insulin responses

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI < 30 kg/m2
  • Eating and tolerating meat, egg, pea, rice, and potatoes
  • No current chronic or infectious disease
  • No medication (oral contraceptive pill and mild antidepressants is allowed)
  • No dietary supplements
  • Did not use antibiotics in the 6 previous months

Exclusion criteria

  • Any condition that makes the project responsible researcher to doubt the feasibility of the volunteer's participation
  • Pregnant or lactating women
  • Smoking (12 months of non-smoking is allowed)
  • Vegan or vegetarian
  • Have or have had a drug addiction
  • Blood donations within three months before participating in the current trial or participation in other scientific experiments
  • Alcohol consumption higher than the Danish Health Authority recommendation of 7 or 14 drinks/week for women and men, respectively.

Treatment and study plan

Meal sequence: 3C1A2B4D

Other

Participants receive test meals in the sequence 3C1A2B4D

Meal sequence: 2A3D4C1B

Other

Participants receive test meals in the sequence 2A3D4C1B

Meal sequence: 2D4B3A1C

Other

Participants receive test meals in the sequence 2D4B3A1C

Meal sequence: 3B2C1D4A

Other

Participants receive test meals in the sequence 3B2C1D4A

Meal sequence: 4C2B1A3D

Other

Participants receive test meals in the sequence 4C2B1A3D

Meal sequence:1B4D3C2A

Other

Participants receive test meals in the sequence 1B4D3C2A

Meal sequence:4A1C2D3B

Other

Participants receive test meals in the sequence 4A1C2D3B

Meal sequence:1D3A4B2C

Other

Participants receive test meals in the sequence 1D3A4B2C

Meal sequence: 4D3B2C1A

Other

Participants receive test meals in the sequence 4D3B2C1A

Meal sequence: 3A4C1B2D

Other

Participants receive test meals in the sequence 3A4C1B2D

Meal sequence: 1C2A3D4B

Other

Participants receive test meals in the sequence 1C2A3D4B

Meal sequence: 2B1D4A3C

Other

Participants receive test meals in the sequence 2B1D4A3C

Primary outcomes

  1. Urinary meat metabolites (metabolic profiling with mass spectrometry)

    Time frame: Hours 0-48

    Explorative approach to discover biomarkers of general meat intake and to differentiate between different types of meat

  2. Plasma meat metabolites (metabolic profiling with mass spectrometry)

    Time frame: Hours 0-48

    Explorative approach to discover biomarkers related to general meat intake and/or specific types of meat

  3. Urinary potato metabolites (metabolic profiling with mass spectrometry)

    Time frame: Hours 0-48

    Explorative approach to discover biomarkers of general potato intake and to differentiate between different cooking methods

  4. Plasma potato metabolites (metabolic profiling with mass spectrometry)

    Time frame: Hours 0-48

    Explorative approach to discover biomarkers related to general potato intake and/or related to different cooking methods

  5. Objective assessment of satiety

    Time frame: Hours 0-7

    Measured by the weight of an ad libitum meal

Secondary outcomes

  1. Urine biomarkers of meat intake

    Time frame: Hours 0-48

    Targeted approach with mass spectrometry on already proposed meat biomarkers

  2. Subjective assessment of satiety

    Time frame: Hours 0-6

    Assessed by visual analogue scale (VAS)

  3. Area under the curve for glucose

    Time frame: Minutes 0-180

    Glucose is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.

  4. Area under the curve for insulin

    Time frame: Minutes 0-180

    Insulin is measure at 0, 45, 90, 120, and 180 min after the test meal and the area is determined by the trapezoid method.

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Biomarkers of Meats and Potatoes Intake: a Meal Study in Healthy Men and Women - the MEPO Study.

Acronym: MEPO

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 10, 2017
Registry last updated
Oct 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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