Nutritional Biomarker Screening for Defined Food Groups

NCT05067465 | Completed

• 1 other identifier: H12_21
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The Biomarker study will be conducted (i) to establish biomarker profiles that reflect the daily diet and regularly dietary habits, (ii) to complement self-reported dietary habits and (iii) to reduce gaps between self-reported information and real dietary intake. The study aims to assess relationships between defined nutrient intake (four groups: 1. Milk and dairy products, 2. Whole-grain products (rich in soluble fibers), 3. Sausage and processed meat (pork), 4. Meat-free sausage and meat alternatives (based on egg, soy) and resulting biochemical markers in human samples (plasma, serum, 24 h urine). In a next step, we will focus on unraveling the connection of the established diet-related metabolites with biomarkers of health and disease status, with focus on cardiovascular diseases (CVD).

Conditions

Healthy Lifestyle

Keywords

dairy products, whole grains, sausage, soy

Outcome Measures

Primary Outcomes (1)

• Fatty acids, concentration in %fatty acid methyl esters

  Fatty acids distribution in plasma lipids, inclusive odd-chain fatty acids

  Change from baseline after 5 days of the standardised diet

Secondary Outcomes (12)

• 1-methylhistidineanserine, concentration

  Change from baseline after 5 days of the standardised diet

• 3-methylhistidineanserine, concentration

  Change from baseline after 5 days of the standardised diet

• Asymmetric dimethylarginine, concentration

  Change from baseline after 5 days of the standardised diet

• Homoarginine, concentration

  Change from baseline after 5 days of the standardised diet

• Trimethylamine N-oxide, concentration

  Change from baseline after 5 days of the standardised diet

Other Outcomes (10)

• Body mass index, kg/m2

  Change from baseline after 5 days of the standardised diet

• Systolic blood pressure, mm Hg

  Change from baseline after 5 days of the standardised diet

• Diastolic blood pressure, mm Hg

  Change from baseline after 5 days of the standardised diet

Study Arms (4)

Milk and dairy products

EXPERIMENTAL

Standardized diet over five days (n = 40) - composed of cow milk, cheese, cream cheese, cream, valess milk schnitzel Test meal on day 6 (n = 12) - composed of milk, cheese, cream cheese, cream

Dietary Supplement: Selected food groups

Whole-grain products (rich in soluble fibers)

EXPERIMENTAL

Standardized diet over five days (n = 40) - composed of oatmeal, oat bran, oat milk, whole wheat pasta, whole wheat bread, hummus Test meal on day 6 (n = 12) - composed of oatmeal, oat bran, oat milk

Dietary Supplement: Selected food groups

Sausage and processed meat (pork)

EXPERIMENTAL

Standardized diet over five days (n = 40) - composed of Lyoner (pig), Viennese (pig), minced meat (pig) Test meal on day 6 (n = 12) - composed of Lyoner (pig), Viennese (pig)

Dietary Supplement: Selected food groups

Meat-free sausage and meat alternatives (based on egg, pea, soy)

EXPERIMENTAL

Standardized diet over five days (n = 40) - composed of Mortadella (egg-based), Viennese (egg-based), vegan mince (soy-based) Test meal on day 6 (n = 12) - composed of Mortadella (egg-based), Viennese (egg-based)

Dietary Supplement: Selected food groups

Interventions

Selected food groups DIETARY_SUPPLEMENT

Food groups 1. Milk and dairy products 2. Whole-grain products (rich in soluble fibers) 3. Sausage and processed meat (pork) 4. Meat-free sausage and meat alternatives (based on egg, soy)

Meat-free sausage and meat alternatives (based on egg, pea, soy); Milk and dairy products; Sausage and processed meat (pork); Whole-grain products (rich in soluble fibers)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females (before menopause) and males
• Age: 20 \< 40 years
• BMI ≥ 18 \< 25 kg/m2
• Participants must be subjectively healthy
• Compatibility to one of the four planned groups as confirmed by lifestyle and nutrition-related questionnaires plus food frequency protocol (FFP) over five days
• Precondition: stable eating habits at least one year before enrollment

You may not qualify if:

• Subjects with any acute or chronic disease (tumor, infection, other), gastrointestinal diseases, dia-betes mellitus (type I, II), chronic renal disease, diseases of the parathyroid, diseases necessitating regular phlebotomies
• Intake of additional dietary supplements (e.g. fish oil capsules, vitamins, minerals etc.)
• Weight loss or weight gain (\> 3 kg) during the last three months before study begin
• Pregnancy or lactation
• Transfusion of blood in the last three months before blood sample taking

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Institute of Nutritional Sciences

Jena, Thuringia, 07743, Germany

Location

Related Links

• Website of the study center

Study Officials

• Christine Dawczynski, PhD

  Friedrich-Schiller-University Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Standardized diet over five days (n = 4x40) and test meal on day 6 with postprandial profiling (n = 4x12): Four groups characterized by defined intake of: 1. Milk and dairy products 2. Whole-grain products (rich in soluble fibers) 3. Sausage and processed meat (pork) 4. Meat-free sausage and meat alternatives (based on egg, soy)

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 5, 2021
• Study Start: October 14, 2021
• Primary Completion: November 19, 2021
• Study Completion: February 28, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)