Trial document




drksid header

  DRKS00008787

Trial Description

start of 1:1-Block title

Title

Metabolomics study for the identification of biomarkers of food intake

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

In order to investigate the association between nutrition and health or the occurrence of disease, it is necessary to determine the intake of food or nutrition habits. Generally, this is achieved using questionnaires. However, for most people it is difficult to remember what they have eaten and especially difficult to estimate the quantity of the food ingested. On the other hand, if humans are observed or if they have to record what they are eating, most will alter their behavior, consciously or unconsciously. Therefore, data derived from such dietary intake assessments are often inaccurate.
The enormous development of analytical methods allows the simultaneous detection of hundreds of substances from a single sample. This assay is termed “metabolomics”. With the aid of metabolomics methods the aim is to find – complementary to the common methods for the assessment of food intake - so called biomarkers for the ingestion of foods. These are substances that can be detected in blood or urine after the consumption of a specific food and can thus serve as an objectively measurable proof for the consumption of this food.
The aim of this study is to find potential biomarkers for the intake of two selected food items, namely apples and sugar sweetened beverages.
During three appointments, each at least one week apart, volunteers will ingest in random order either apples or a sugar sweetened beverage together with a liquid control diet or the liquid control diet alone together with water. During each of the appointments, within a 24h period, blood and urine samples will be collected at predefined intervals, and again at 48h after the ingestion of the foods. From these blood and urine samples, the potential biomarkers can be identified. In parallel, over the time-course of 48h, blood sugar concentrations will be continuously determined by a sensor that can be attached to the upper arm.
Since an association between bacterial communities in the gut (microbiota) and the blood sugar response to different foods was recently described, stool samples will be collected from the study participants during the first 24h in which they will be residing at the study center. From these stool samples, the composition of the gut microbiota will be determined and tested for an association with blood sugar levels.

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

Brief Summary in Scientific Language

A known limitation in modern nutrition research is the quality of dietary assessment methods. In order to improve the possibilities to investigate the association between nutrition and health, biomarkers for food intake could be helpful in addition to classical methods for dietary intake assessment. However, to date only few such food biomarkers have been sufficiently validated and accepted for the assessment of food intake or nutrition status. In the present study the aim is to identify potential biomarkers for sugar containing foods (here: apples and sugar sweetened beverages).
Therefore, 12 healthy men and women aged 18 – 40 years will ingest these foods as a test meal in a cross-over design study. A formula diet will serve as control. At defined time points before and after ingestion of the test meals, blood and urine samples will be collected and analyzed by different methods, such as LC-MS, GC-MS and NMR, in order to cover as wide a metabolite spectrum as possible. On the one hand, potential biomarkers for the ingestion of the test foods shall be identified with the aid of bioinformatics and biostatistical methods, by comparing the metabolite profiles in blood and urine after ingestion of the test foods with metabolite profiles after ingestion of the control food. On the other hand, due to the repeated sampling over the time-course of 48h, it is possible to determine the biokinetics of selected food ingredients. In parallel, glycemic response to the sugar containing foods will be determined in more detail by a sensor for continuous blood glucose monitoring. In addition, within the first 24h after ingestion of the test foods, stool samples will be collected to determine the composition of the gut microbiota and their genetic potential (metagenome), in order to verify a recently described association of gut microbiota and glycemic response to different foods.

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

Organizational Data

  •   DRKS00008787
  •   2016/02/09
  •   [---]*
  •   yes
  •   Approved
  •   F-2015-101, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1177-1536 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   healthy volunteers
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   400g apples + 200 mL reference meal (= formula diet)
  •   500 mL sugar sweetened carbonated beverage (cola) + 200 mL reference meal (= formula diet)
  •   500 mL water + 200 mL reference meal (= formula diet)
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 the metabolite profile in plasma and urine by LC-MS/MS, GCxGC-MS, and NMR before, and 1, 2, 4, 6, 12, 24, and 48h after a single ingestion of the test meal in comparison to the control meal (formula diet = reference meal)

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

Secondary Outcome

Anthropometric examinations (height, weight, hip and waist circumference) using standard methods.
Continuous monitoring of interstitial glucose concentrations by a flash-glucose monitoring system (Freesyle LIBRE, Abbott Diabetes Care).
Composition of gut microbiota and their genetic potential by 16S and shotgun sequencing.

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
  •   2016/02/16
  •   12
  •   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 (18 – 40 years)
BMI 18.5 – 30 kg/m2
Non-smoking
Volunteers who gave their written informed consent to participate in the study

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

Exclusion Criteria

Volunteers with diseases affecting the nutrient absorption, digestive function, metabolism or excretion of nutrients
Smokers
Volunteers regularly taking and medication (except hormonal contraceptives)
Volunteers who took supplements in the past 4 weeks
Volunteers who took antibiotics in the past 6 months
Volunteers who donated blood in the past 3 months
Pregnant or lactating women
Volunteers with known allergies/intolerances to one of the tested foods or one of the ingredients of the formula diet
Volunteers who can be expected not to comply with the study protocol
Volunteers who are institutionalized due to an administrative order or court order

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • 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
    • Max Rubner-Institut; Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dr. rer. nat.  Manuela  Rist 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Max Rubner-Institut; Bundesforschungsinstitut für Ernährung und Lebensmittel
    • Ms.  Dipl.oec.troph. (FH)  Anita  Kriebel 
    • Haid-und-Neu-Str.9
    • 76131  Karlsruhe
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    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
    • Bundesministerium für Ernährung und Landwirtschaft
    • Rochusstr.1
    • 53123  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
  • start of 1:1-Block address otherSupport
    • Teilprojekt des JPI HDHL BioNH "FOODBALL"; Förderkennzeichen: 2814ERA03E
    • Bundesanstallt für Landwirtschaft und Ernährung 
    • Deichmanns Aue 29
    • 53179  Bonn
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/03/30
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.