Human Intervention Study for Validating Foods With Improved Nutrient Profile

NCT04113837 | Completed

• 1 other identifier: H9_19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)).

Conditions

Cardiovascular Risk Factor

Keywords

foods, nutrient profile, dietary fiber, omega 3 fatty acids

Outcome Measures

Primary Outcomes (1)

• LDL cholesterol

  cardiovascular risk factor

  change from baseline after 4 weeks

Secondary Outcomes (34)

• blood lipids

  change from baseline after 4 weeks

• anthropometric data

  change from baseline after 4 weeks

• blood pressure

  change from baseline after 4 weeks

• lipoprotein a

  change from baseline after 4 weeks

• high-sensitive c-reactive protein

  change from baseline after 4 weeks

Study Arms (2)

verum

EXPERIMENTAL

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)

Dietary Supplement: food range

control

ACTIVE COMPARATOR

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.

Dietary Supplement: food range

Interventions

food range DIETARY_SUPPLEMENT

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

control; verum

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jena: lead

Study Sites (1)

Friedrich Schiller University

Jena, Thuringia, 07743, Germany

Location

Related Links

• recruiting

Study Officials

• Christine Dawczynski, PhD

  University of Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The foods are offered in neutral packaging and are provided regularly by the study team. All personal (participants, care provider) are blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: October 29, 2019
• Primary Completion: March 16, 2020
• Study Completion: March 23, 2020
• Last Updated: March 25, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)