Trial document




drksid header

  DRKS00010133

Trial Description

start of 1:1-Block title

Title

Testing of foods and validation of biomarkers to assess nutritional status

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

FOODBALL

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

By means of questionnaires food intake and eating habits are usually surveyed. These data could provide information about the relation between diet and health. Unfortnately these data are imprecise: food could be forgotten to be recorded, portion size could be estimated wrong, meals eaten in e.g. restaurants are estimeated wrong (concerning ingredients and portion size).

Biomarkers that could be measured in blood and urine samples after a single intake could provide objective evidence for the food intake.

The aim of this study is to identify biomarkers for certain foods, namely chicken breast, fibers, and egg.

Therefore 12 healthy female and male volunteers (6/6),18 to 40 years of age are asked to consume the selected foods in an open-randomised cross-over study. At defined timepoints before and after the intake blood and urin samples are going to be collected and analyzed using methods like LC-MS/MS, GCxGC-MS, and NMR. The collection of blood and urin samples over a time period of 24 and 48 hours will allow analysis of the biokinetics of the food ingredients or its metabolites.

The study consists of three parts.

In the chicken breast meat intervention participants are invited to three separate appointments. They will receive in a random order either 100g cooked chicken breast or 200g cooked chicken breast (with rice) or as a control food rice only.

In the fiber intervention participants are invited to three separate appointments. They will receive in a random order either 5g inulin (solved in water) or 5g beta-glucan (solved in water)(together with toast) or as control food toastbread (without crust).

In the egg intervention participants (vegan/vegetarian) are invited to two separate appointments. They will receive in a random order either two boiled eggs (together with rice) or as control food rice only.

In all three parts of the study blood samples will be drawn at timepoints: 0,1,2,4,6,12, and 24h. Urine samples will be collected as follows: 0-1h, 1-2h, 2-4h, 4-6h, 6-12h, 12-24h, 48h. In the egg intervention there will be no 48h urine sampling.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

A major issue in nutritional science is the quality of dietary assessment. Assessment of the intake of foods, food ingredients and food contaminants is an extensive challenge and
questionnaires may give biased results.[1, 2] Biomarkers covering several foods and food
components may provide an objective measure of actual intake and/or status, and provide an important adjunct to classical methods for dietary assessment. However, only few foods are currently covered by validated intake biomarkers.[3] Although several authorities have presented general concepts for identification of biomarkers in disease, clear recommendations on biomarkers concerning nutrition and health are lacking. Whereas many dietary biomarkers have been described, few are sufficiently validated and accepted as biomarkers of intake and/or nutritional status. Indeed, the rapid development of metabolomics has recently led to a surge of potential biomarkers [3] and new biomarker candidates appear at an increasing rate in the literature. [4-6] Therefore the aim of this study is to identify biomarkers for certain foods, namely chicken breast, fibers, and egg. 12 healthy female and male volunteers (6/6),18 to 40 years of age are asked to consume the selected foods in an open-randomised cross-over study. At defined timepoints before and after the intake of the food blood and urine samples are going to be collected and analyzed using methods like LC-MS/MS, GCxGC-MS, and NMR. The collection of blood and urine samples over a time period of 24 and 48 hours will allow analysis of the biokinetics of the food ingredients or its metabolites.

The study consists of three parts.

In the chicken breast meat intervention participants are invited to three separate appointments. They will receive in a random order either 100g cooked chicken breast or 200g cooked chicken breast (with rice) or as a control food rice only.

In the fiber intervention participants are invited to three separate appointments. They will receive in a random order either 5g inulin (solved in water) or 5g beta-glucan (solved in water)(together with toast) or as control food toastbread (without crust).

In the egg intervention participants (vegan/vegetarian) are invited to two separate appointments. They will receive in a random order either two boiled eggs (together with rice) or as control food rice only.

In all three parts of the study blood samples will be drawn at timepoints: 0,1,2,4,6,12, and 24h. Urine samples will be collected as follows: 0-1h, 1-2h, 2-4h, 4-6h, 6-12h, 12-24h, 48h. In the egg intervention there will be no 48h urine sampling.


Literature
1. Jenab M, Slimani N, Bictash M, Ferrari P, Bingham SA. Biomarkers in nutritional epidemiology: applications, needs and new horizons. Human genetics 2009; 125(5‐6): 507‐25.
2. Penn L, Boeing H, Boushey CJ, et al. Assessment of dietary intake: NuGO symposium report. Genes & nutrition 2010; 5(3): 205‐13.
3. Scalbert A, Brennan L, Manach C, et al. The food metabolome: a window over dietary exposure. The American journal of clinical nutrition 2014; 99(6): 1286‐308.
4. Garcia‐Aloy M, Llorach R, Urpi‐Sarda M, et al. Novel multi‐metabolite prediction of walnut consumption by a urinary biomarker model in a free‐living population. Journal of proteome research 2014.
5. Hjerpsted J, Ritz C, Schou S, Tholstrup T, Dragsted L. Effect of cheese and butter intake on metabolites in urine using an untargeted metabolomics approach. Metabolomics 2014: 1‐10.
6. Stanstrup J, Schou SS, Holmer‐Jensen J, Hermansen K, Dragsted LO. Whey Protein Delays Gastric Emptying and Suppresses Plasma Fatty Acids and Their Metabolites Compared to Casein, Gluten, and Fish Protein. Journal of proteome research 2014.


end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00010133
  •   2016/04/06
  •   [---]*
  •   yes
  •   Approved
  •   51/16S, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   specific biomarkers for chicken breast meat, fibers (inulin, beta.glucan), and egg in healthy female and male volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   The study consists of three parts.

    In the chicken breast meat intervention participants are invited to three separate appointments. They will receive in a random order either 100g cooked chicken breast or 200g cooked chicken breast (with rice) or as a control food rice only.

    In the fiber intervention participants are invited to three separate appointments. They will receive in a random order either 5g inulin (solved in water) or 5g beta-glucan (solved in water)(together with toast) or as control food toastbread (without crust).

    In the egg intervention participants (vegan/vegetarian) are invited to two separate appointments. They will receive in a random order either two boiled eggs (together with rice) or as control food rice only.

    In all three parts of the study blood samples will be drawn at timepoints: 0,1,2,4,6,12, and 24h. Urine samples will be collected as follows: 0-1h, 1-2h, 2-4h, 4-6h, 6-12h, 12-24h, 48h. In the egg intervention there will be no 48h urine sampling.

    Control food in the chickenbreast meatintervention consisting of 125g rice, 30g margarine, and 1,5g salt
  •   chicken breast meatintervention consisting of 100g chicken breast (cooked) with 125g rice, 30g margarine, and 1,5g salt
  •   chicken breast meatintervention consisting of 200g chicken breast (cooked) with 125g rice, 30g margarine, and 1,5g salt
  •   control food in the fiber intervention consisting of 75g toast (without crust)
  •   fiber intervention consisting of 5g inulin (in water) with 75g toast (without crust)
  •   fiber intervention consisting of 5g beta-glucan (in water) with 75g toast (without crust)
  •   control food in the egg intervention consisting of 125g rice, 30g margarine, and 1,5g salt
  •   egg intervention concsisting of 2 boiled eggs with125g rice, 30g margarine, and 1,5g salt
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Analysis of metabolites in plasma and urine using LC-MS/MS, GCxGC-MS, and NMR after a single consumption of chickenbreast (100g and 200g), fibers (inulin and beta-glucan), and egg compared to controlfood (for chickenbreast and egg:rice; for fibers:toastbred). Timepoints for taking blood samples are 0, 1,2,4,6,12,and 24 hours. Timepoints for urinesampling are 0-1h, 1-2h, 2-4h, 4-6h, 6-12h, 12-24h, 48h.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

/

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/03/09
  •   36
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   40   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

-healthy women and men (age 18-40 years)
-BMI <30 kg/m2
-non-smokers
-informed consent

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

-smokers
--gastro-intestinal diseases resulting in malabsorption, digestion
-diseases impairing metabolism and excretion
-chronic illness
-acute infection
-intake of antibiotics in the last 6 months
-regular intake of medication (exception: oral contraceptive)
-pregnant and lactating women
-known allergies or intolerance to tested foods





end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Else Kröner-Fresenius-Zentrum für Ernährungsmedizin der TU München Lerhrstuhl für Ernährungsmedizin
    • Mr.  Prof.Dr.med.  Hans  Hauner 
    • Gregor-Mendel-Str. 2
    • 85354  Freising-Weihenstephan
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • ZIEL Institute for Food and Health Ernährungsmedizinan der Technischen Universität München
    • Mr.  Prof Dr.med.  Thomas  Skurk 
    • Gregor-Mendel-Str. 2
    • 85354  Freising-Weihenstephan
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   08161-712007
    •   08161-712097
    •   skurk at tum.de
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • ZIEL Institute for Food and Health Ernährungsmedizinan der Technischen Universität München
    • Ms.  Dipl.oec.troph.  Yu-Mi  Lee 
    • Gregor-Mendel-Str. 2
    • 85354  Freising-Weihenstephan
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   08161-712007
    •   08161-712097
    •   y.lee at tum.de
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesanstalt für Landwirtschaft und Ernährung
    • Teilprojekt des JPI HDHL BioNH "FOODBALL"; Förderkennzeichen:2814ERA03E 
    • Deichmanns Aue 29
    • 53179  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2017/01/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.