Human Intervention Study for Validating Foods With Improved Nutrient Profile

Cardiovascular Risk Factor Clinical Trial

Official title:

Human Intervention Study for Validating the Influence of Regular Consumption of Foods With Improved Nutrient Profile on Cardiovascular Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04113837
• Other study ID #: H9_19
• Status: Completed
• Phase: N/A
• Start date: October 29, 2019
• Est. completion date: March 23, 2020

Study information

• Verified date: September 2019
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 23, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Germany	Friedrich Schiller University	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL cholesterol	cardiovascular risk factor	change from baseline after 4 weeks
Secondary	blood lipids	total cholesterol, HDL cholesterol, triglycerides in mmol/l	change from baseline after 4 weeks
Secondary	anthropometric data	body mass index (kg/m2)	change from baseline after 4 weeks
Secondary	blood pressure	systolic blood pressure (mm Hg) diastolic blood pressure (mmHg)	change from baseline after 4 weeks
Secondary	lipoprotein a	lipoprotein a (mg/l)	change from baseline after 4 weeks
Secondary	high-sensitive c-reactive protein	high-sensitive c-reactive protein (mg/dl)	change from baseline after 4 weeks
Secondary	homocysteine	homocysteine (µmol/l)	change from baseline after 4 weeks
Secondary	apolipoproteins	apolipoproteins A1, B (g/l)	change from baseline after 4 weeks
Secondary	glucose (fasting)	glucose (fasting) (mmol/l)	change from baseline after 4 weeks
Secondary	insulin (fasting)	insulin (fasting) (mU/l)	change from baseline after 4 weeks
Secondary	hemoglobin A1c (fasting)	hemoglobin A1c (fasting) (%)	change from baseline after 4 weeks
Secondary	malodialdehyde modified LDL cholesterol	malodialdehyde modified LDL cholesterol (U/l)	change from baseline after 4 weeks
Secondary	fatty acid distribution in plasma lipids	fatty acid distribution in plasma lipids (%FAME)	change from baseline after 4 weeks
Secondary	aspartate transaminase (AST)	aspartate transaminase (AST)	change from baseline after 4 weeks
Secondary	alanine transaminase (ALT)	alanine transaminase (ALT)	change from baseline after 4 weeks
Secondary	gamma-glutamyltransferase	gamma-glutamyltransferase (gGT)	change from baseline after 4 weeks
Secondary	Lactate dehydrogenase	Lactate dehydrogenase (LDH)	change from baseline after 4 weeks
Secondary	cholinesterase	cholinesterase	change from baseline after 4 weeks
Secondary	kalium	kalium (mmol/l)	change from baseline after 4 weeks
Secondary	transferrin	transferrin (g/l)	change from baseline after 4 weeks
Secondary	ferritin	ferritin (µg/l)	change from baseline after 4 weeks
Secondary	bioelectrical impedance	body water, body fat, lean body mass, extracellular mass (ECM), body cell mass (BCM)	change from baseline after 4 weeks
Secondary	vitamin A	vitamin A (mmol/l)	change from baseline after 4 weeks
Secondary	vitamin D	vitamin A (nmol/l)	change from baseline after 4 weeks
Secondary	vitamin E	vitamin E (µmol/l)	change from baseline after 4 weeks
Secondary	vitamin B1	vitamin B1 (nmol/l)	change from baseline after 4 weeks
Secondary	vitamin B6	vitamin B6 (nmol/l)	change from baseline after 4 weeks
Secondary	vitamin B12	vitamin B12 (pmol/l)	change from baseline after 4 weeks
Secondary	vitamin B12 status	holotranscobalamine (pmol/l)	change from baseline after 4 weeks
Secondary	creatinine	creatinine (mmol/24 h)	change from baseline after 4 weeks
Secondary	natrium	natrium (mmol/24 h)	change from baseline after 4 weeks
Secondary	magnesium	magnesium (mmol/24 h)	change from baseline after 4 weeks
Secondary	zinc	zinc (µmol/24 h)	change from baseline after 4 weeks
Secondary	albumine	albumine (mg/l) (24 h urine)	change from baseline after 4 weeks
Secondary	uric acid	uric acid (mg/dl) (24 h urine)	change from baseline after 4 weeks

External Links

•   recruiting