Human Intervention Study for Validating Foods With Improved Nutrient Profile
Condition: Cardiovascular Risk Factor
Study type: Interventional

Summary: 
      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)).
    

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.
    

Intervention name(s): food range
Intervention type(s): Dietary Supplement
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The controlled, randomized, double-blind crossover study consists of a 4-week investigation periods with a 11-week wash-out period in between. At the beginning, participants are randomly allocated into the verum or the control/placebo group. After the wash-out phase the interventions are crossed between the groups and the respective food range is consumed also for four weeks.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: foods, nutrient profile, dietary fiber, omega 3 fatty acids