Human Intervention Study for Validating Foods With Improved Nutrient Profile

University of Jena

Status: Completed

Conditions: Cardiovascular Risk Factor

Treatments: Dietary Supplement: food range

Study type: Interventional

Funder types: Other

Identifiers

NCT04113837

H9_19

Details and patient eligibility

About

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)).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

verum

Experimental group

Description:

The food range is comprised of: sausages (1100 g per week / exchange of saturated fatty acids by long-chain unsaturated omega-3 fatty acids from fish oil (Maris Oil ED0222N rich in docosahexaenoic acid (DHA)), partially exchange of fat by plant protein (sesame)), eggs (3 eggs per week / 2 µg vitamin D per egg), 100 g mushrooms per day (5 µg Vitamin D/d), one bread per week (5 µg Vitamin D/d), bread rolls (16 g dietary fibers/d), 100 ml ice cream per week (exchange of sugar by xylitol), 3x 70 g pasta per week (3 x 10 g dietary fibers per week)

Treatment:

Dietary Supplement: food range

control

Active Comparator group

Description:

In the placebo period, the participants receive commercially available foods (sausages (raw, boiled and cooked varieties), eggs, mushrooms, bread, bread rolls, ice cream and pasta) with traditional nutrient profile.

Treatment:

Dietary Supplement: food range