Human Intervention Study for Validating Foods With Improved Nutrient Profile

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

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)).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Dietary supplement: food range

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Friedrich Schiller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LDL cholesterol	cardiovascular risk factor	change from baseline after 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jena

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: foods, nutrient profile, dietary fiber, omega 3 fatty acids
• Other Study ID Numbers: H9_19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No