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Human Intervention Study for Validating Foods With Improved Nutrient Profile

24. März 2020 aktualisiert von: Christine Dawczynski,PhD, University of Jena

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)).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

25 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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)
Nahrungsergänzungsmittel: 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
Aktiver Komparator: 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.
Nahrungsergänzungsmittel: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
LDL cholesterol
Zeitfenster: change from baseline after 4 weeks
cardiovascular risk factor
change from baseline after 4 weeks

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Jena

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

29. Oktober 2019

Primärer Abschluss (Tatsächlich)

16. März 2020

Studienabschluss (Tatsächlich)

23. März 2020

Studienanmeldedaten

Zuerst eingereicht

1. Oktober 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Oktober 2019

Zuerst gepostet (Tatsächlich)

3. Oktober 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. März 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. März 2020

Zuletzt verifiziert

1. September 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • H9_19

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