Human Intervention Study for Validating the Influence of Regular Consumption of Foods With Improved Nutrient Profile on Cardiovascular Risk Factors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- LDL cholesterol
Study Overview
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 available foods (control) by a controlled, randomized, double-blind crossover study with patients with measurable cardiovascular risk factors (LDL cholesterol ≥ 120 mg/dl (≥ 3 mmol/l) / Triacylglycerides ≥ 135 mg/dl (≥ 1,5 mmol/l)).
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 available foods (control/placebo).
The controlled, randomized, double-blind crossover study consists of 4-week investigation periods with a 11-week wash-out period in between. Patients (men, female, n = 54 + 6) with measurable cardiovascular risk (LDL cholesterol ≥ 120 mg/dl (≥ 3 mmol/l) / triacylglycerides ≥ 135 mg/dl (≥ 1,5 mmol/l)), are involved.
The product range includes sausages (raw, boiled and cooked varieties) and pasta fortified with dietary fibers, fish oil and plant protein, resulting in a reduction of fat and energy content. Eggs, bread, bread rolls, and mushrooms with higher vitamin D content complete the innovative product range. Additionally, participants receive ice cream where sugar is replaced by xylite.
In the control period, the participants receive commercially available foods (sausages (raw, boiled and cooked varieties), pasta, eggs, bread, bread rolls, and mushrooms, ice cream) with traditional nutrient profile.
The products will be offered in neutral packaging and are provided regularly by the study team. All personal (participants, physicians) are blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
The foods are offered in neutral packaging and are provided regularly by the study team. All personal (participants, care provider) are blinded.
Eligibility Criteria
- Ages
- 25 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
LDL cholesterol
Time Frame: change from baseline after 4 weeks
cardiovascular risk factor
Secondary Outcomes
- high-sensitive c-reactive protein(change from baseline after 4 weeks)
- blood lipids(change from baseline after 4 weeks)
- homocysteine(change from baseline after 4 weeks)
- glucose (fasting)(change from baseline after 4 weeks)
- hemoglobin A1c (fasting)(change from baseline after 4 weeks)
- uric acid(change from baseline after 4 weeks)
- apolipoproteins(change from baseline after 4 weeks)
- aspartate transaminase (AST)(change from baseline after 4 weeks)
- alanine transaminase (ALT)(change from baseline after 4 weeks)
- transferrin(change from baseline after 4 weeks)
- vitamin B1(change from baseline after 4 weeks)
- anthropometric data(change from baseline after 4 weeks)
- blood pressure(change from baseline after 4 weeks)
- lipoprotein a(change from baseline after 4 weeks)
- cholinesterase(change from baseline after 4 weeks)
- kalium(change from baseline after 4 weeks)
- creatinine(change from baseline after 4 weeks)
- magnesium(change from baseline after 4 weeks)
- insulin (fasting)(change from baseline after 4 weeks)
- malodialdehyde modified LDL cholesterol(change from baseline after 4 weeks)
- fatty acid distribution in plasma lipids(change from baseline after 4 weeks)
- gamma-glutamyltransferase(change from baseline after 4 weeks)
- vitamin A(change from baseline after 4 weeks)
- vitamin B6(change from baseline after 4 weeks)
- vitamin B12(change from baseline after 4 weeks)
- natrium(change from baseline after 4 weeks)
- zinc(change from baseline after 4 weeks)
- albumine(change from baseline after 4 weeks)
- Lactate dehydrogenase(change from baseline after 4 weeks)
- ferritin(change from baseline after 4 weeks)
- vitamin D(change from baseline after 4 weeks)
- vitamin E(change from baseline after 4 weeks)
- vitamin B12 status(change from baseline after 4 weeks)
- bioelectrical impedance(change from baseline after 4 weeks)
Investigators
Christine Dawczynski,PhD
PhD
University of Jena