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Human Intervention Study for Validating Foods With Improved Nutrient Profile

24 de marzo de 2020 actualizado por: 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)).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

25 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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)
Suplemento dietético: 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
Comparador activo: 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.
Suplemento dietético: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
LDL cholesterol
Periodo de tiempo: change from baseline after 4 weeks
cardiovascular risk factor
change from baseline after 4 weeks

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Jena

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de octubre de 2019

Finalización primaria (Actual)

16 de marzo de 2020

Finalización del estudio (Actual)

23 de marzo de 2020

Fechas de registro del estudio

Enviado por primera vez

1 de octubre de 2019

Primero enviado que cumplió con los criterios de control de calidad

1 de octubre de 2019

Publicado por primera vez (Actual)

3 de octubre de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de marzo de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

24 de marzo de 2020

Última verificación

1 de septiembre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • H9_19

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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