Status:
COMPLETED
Human Intervention Study for Validating Foods With Improved Nutrient Profile
Lead Sponsor:
University of Jena
Conditions:
Cardiovascular Risk Factor
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The proposed intervention study is designed to evaluate the physiological impact of the regular consumption of the developed foods with improved nutrient profile (verum) in comparison to commercial av...
Detailed Description
The proposed intervention study is designed to evaluate the physiological impact of regularly consumption of the food range with improved nutrient profile (verum) in comparison to commercially availab...
Eligibility Criteria
Inclusion
- females and males
- BMI \< 30 kg/m2
- subjects must be able and willing to give written informed consent, and to comply with study procedures
- Participants following a traditional Western diet composed of dairy products, sausage, meat, fast foods, chocolate and snacks, cereals, vegetables, and fruits (PAL: 1.6)
- Precondition: Stable eating habits of at least one years before enrolment
- subjects with moderate elevated LDL cholesterol (≥ 3 mmol/l) and triacylglyceride concentrations (≥ 1.5 mmol/l) in plasma, without lipid-lowering medication
- stable dose of antihypertensive medication for \> 3 months before study and during the entire study period or without antihypertensive medication
- subjects must have adequate fluency in the German language to complete the questionnaires and understand the nutritional recommendations
Exclusion
- subjects with any acute or chronic disease (CVD, tumor, infection, other), gastrointestinal diseases, diabetes mellitus (type I and II), chronic renal disease, diseases of the parathyroid, diseases necessitating regular phlebotomies other chronic diseases which could affect the results of the present study
- use of prescription medicine which could affect results of the study, including systemic glucocorticoids
- intake of lipid-lowering drugs, diabetes medication, hormone replacement therapy
- estimated glomerular filtration (eGFR) rate \< 60 ml/min
- weight loss (≤ 3 kg) 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
- use of dietary supplements incl. multivitamins, fish oil capsules, minerals, and trace elements (three months before and during the entire study period)
- vegetarians, vegans, food allergies (e.g. milk, nuts etc.)
- dependency on alcohol or drugs
- elite athletes (\>10 hours of strenuous physical activity per week)
- simultaneous participation in other clinical studies
- inability (physically or psychologically) to comply with the procedures required by the protocol
Key Trial Info
Start Date :
October 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04113837
Start Date
October 29 2019
End Date
March 23 2020
Last Update
March 25 2020
Active Locations (1)
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1
Friedrich Schiller University
Jena, Thuringia, Germany, 07743