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Human Intervention Study for Validating Foods With Improved Nutrient Profile

24 mars 2020 mis à jour par: 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)).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

25 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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)
Complément alimentaire: 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
Comparateur actif: 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.
Complément alimentaire: 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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
LDL cholesterol
Délai: change from baseline after 4 weeks
cardiovascular risk factor
change from baseline after 4 weeks

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Jena

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 octobre 2019

Achèvement primaire (Réel)

16 mars 2020

Achèvement de l'étude (Réel)

23 mars 2020

Dates d'inscription aux études

Première soumission

1 octobre 2019

Première soumission répondant aux critères de contrôle qualité

1 octobre 2019

Première publication (Réel)

3 octobre 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

25 mars 2020

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mars 2020

Dernière vérification

1 septembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • H9_19

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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