Clinical trial NCT04113837: Human Intervention Study for Validating Foods With Improved Nutrient Profile
Official title: Human Intervention Study for Validating the Influence of Regular Consumption of Foods With Improved Nutrient Profile on Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: foods, nutrient profile, dietary fiber, omega 3 fatty acids
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The controlled, randomized, double-blind crossover study consists of a 4-week investigation periods with a 11-week wash-out period in between. At the beginning, participants are randomly allocated into the verum or the control/placebo group. After the wash-out phase the interventions are crossed between the groups and the respective food range is consumed also for four weeks.
Primary purpose: TREATMENT

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.

At the beginning, participants are randomly allocated into the verum or the control/placebo group. After the wash-out phase the interventions will be crossed between the groups and the respective products are consumed also for four weeks. In the run-in phase of the study, all patients are invited to a medical examination to ensure the fulfillment of inclusion criteria.

At the beginning and at the end of each study period baseline parameters (BMI, waist-to-hip ratio, blood pressure, bioelectrical impedance measurement) are assessed, lifestyle questionnaires are filled, and venous blood samples are collected for the determination of cardiovascular risk markers.

Subjects document their normal nutritional habits over seven days in a food frequency protocol (FFP) before start and finish of each period. In addition, patients keep a diary for the documentation of nutrition, medication and adverse effects over both study periods.

Eligibility criteria: 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

Primary outcomes:
measure: LDL cholesterol
timeFrame: change from baseline after 4 weeks
Secondary outcomes:
measure: blood lipids
timeFrame: change from baseline after 4 weeks
measure: anthropometric data
timeFrame: change from baseline after 4 weeks
measure: blood pressure
timeFrame: change from baseline after 4 weeks
measure: lipoprotein a
timeFrame: change from baseline after 4 weeks
measure: high-sensitive c-reactive protein
timeFrame: change from baseline after 4 weeks
measure: homocysteine
timeFrame: change from baseline after 4 weeks
measure: apolipoproteins
timeFrame: change from baseline after 4 weeks
measure: glucose (fasting)
timeFrame: change from baseline after 4 weeks
measure: insulin (fasting)
timeFrame: change from baseline after 4 weeks
measure: hemoglobin A1c (fasting)
timeFrame: change from baseline after 4 weeks
measure: malodialdehyde modified LDL cholesterol
timeFrame: change from baseline after 4 weeks
measure: fatty acid distribution in plasma lipids
timeFrame: change from baseline after 4 weeks
measure: aspartate transaminase (AST)
timeFrame: change from baseline after 4 weeks
measure: alanine transaminase (ALT)
timeFrame: change from baseline after 4 weeks
measure: gamma-glutamyltransferase
timeFrame: change from baseline after 4 weeks
measure: Lactate dehydrogenase
timeFrame: change from baseline after 4 weeks
measure: cholinesterase
timeFrame: change from baseline after 4 weeks
measure: kalium
timeFrame: change from baseline after 4 weeks
measure: transferrin
timeFrame: change from baseline after 4 weeks
measure: ferritin
timeFrame: change from baseline after 4 weeks
measure: bioelectrical impedance
timeFrame: change from baseline after 4 weeks
measure: vitamin A
timeFrame: change from baseline after 4 weeks
measure: vitamin D
timeFrame: change from baseline after 4 weeks
measure: vitamin E
timeFrame: change from baseline after 4 weeks
measure: vitamin B1
timeFrame: change from baseline after 4 weeks
measure: vitamin B6
timeFrame: change from baseline after 4 weeks
measure: vitamin B12
timeFrame: change from baseline after 4 weeks
measure: vitamin B12 status
timeFrame: change from baseline after 4 weeks
measure: creatinine
timeFrame: change from baseline after 4 weeks
measure: natrium
timeFrame: change from baseline after 4 weeks
measure: magnesium
timeFrame: change from baseline after 4 weeks
measure: zinc
timeFrame: change from baseline after 4 weeks
measure: albumine
timeFrame: change from baseline after 4 weeks
measure: uric acid
timeFrame: change from baseline after 4 weeks
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University
state: Thuringia
Study officials:
affiliation: University of Jena
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References: