Human Intervention Study for Validating Foods With Improved Nutrient Profile

NCT ID: NCT04113837

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-29
• Study Completion Date: 2020-03-23

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.

Conditions

Cardiovascular Risk Factor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

verum

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)

Group Type: EXPERIMENTAL

food range

Intervention Type: DIETARY_SUPPLEMENT

The food range is comprised of:

sausages (1100 g per week) eggs (3 eggs per week), 100 g mushrooms per day, one bread per week, bread rolls, 100 ml ice cream per week, 3x 70 g pasta per week

control

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.

Group Type: ACTIVE_COMPARATOR

food range

Intervention Type: DIETARY_SUPPLEMENT

The food range is comprised of:

sausages (1100 g per week) eggs (3 eggs per week), 100 g mushrooms per day, one bread per week, bread rolls, 100 ml ice cream per week, 3x 70 g pasta per week

Interventions

food range

The food range is comprised of:

sausages (1100 g per week) eggs (3 eggs per week), 100 g mushrooms per day, one bread per week, bread rolls, 100 ml ice cream per week, 3x 70 g pasta per week

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Jena

OTHER

Sponsor Role: lead

Responsible Party

Christine Dawczynski,PhD

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Dawczynski, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jena

Locations

Friedrich Schiller University

Jena, Thuringia, Germany

Countries

Germany

Related Links

https://www.nuco.uni-jena.de/Rekrutierung.html

recruiting

Other Identifiers

H9_19

Identifier Type: -

Identifier Source: org_study_id