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Human Intervention Study for Validating Foods With Improved Nutrient Profile

24 mars 2020 uppdaterad av: 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)).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

25 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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)
Kosttillskott: 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
Aktiv 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.
Kosttillskott: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
LDL cholesterol
Tidsram: change from baseline after 4 weeks
cardiovascular risk factor
change from baseline after 4 weeks

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

University of Jena

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 oktober 2019

Primärt slutförande (Faktisk)

16 mars 2020

Avslutad studie (Faktisk)

23 mars 2020

Studieregistreringsdatum

Först inskickad

1 oktober 2019

Först inskickad som uppfyllde QC-kriterierna

1 oktober 2019

Första postat (Faktisk)

3 oktober 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 mars 2020

Senast verifierad

1 september 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • H9_19

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NEJ

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Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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