Cardiovascular Risk FactorNCT04113837
Human Intervention Study for Validating Foods With Improved Nutrient Profile
A study testing food range in people with Cardiovascular Risk Factor, run by University of Jena at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- food range
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 29 Oct 2019to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)).
Read the 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.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- food range
- Keywords
- foods, nutrient profile, dietary fiber, omega 3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food rangeDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Dietary Supplement: food range |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
cardiovascular risk factor
Measured: change from baseline after 4 weeks
Secondary outcomes (34)
blood lipids
total cholesterol, HDL cholesterol, triglycerides in mmol/l
Measured: change from baseline after 4 weeks
anthropometric data
body mass index (kg/m2)
Measured: change from baseline after 4 weeks
blood pressure
systolic blood pressure (mm Hg) diastolic blood pressure (mmHg)
Measured: change from baseline after 4 weeks
lipoprotein a
lipoprotein a (mg/l)
Measured: change from baseline after 4 weeks
high-sensitive c-reactive protein
high-sensitive c-reactive protein (mg/dl)
Measured: change from baseline after 4 weeks
homocysteine
homocysteine (µmol/l)
Measured: change from baseline after 4 weeks
apolipoproteins
apolipoproteins A1, B (g/l)
Measured: change from baseline after 4 weeks
glucose (fasting)
glucose (fasting) (mmol/l)
Measured: change from baseline after 4 weeks
insulin (fasting)
insulin (fasting) (mU/l)
Measured: change from baseline after 4 weeks
hemoglobin A1c (fasting)
hemoglobin A1c (fasting) (%)
Measured: change from baseline after 4 weeks
malodialdehyde modified LDL cholesterol
malodialdehyde modified LDL cholesterol (U/l)
Measured: change from baseline after 4 weeks
fatty acid distribution in plasma lipids
fatty acid distribution in plasma lipids (%FAME)
Measured: change from baseline after 4 weeks
aspartate transaminase (AST)
aspartate transaminase (AST)
Measured: change from baseline after 4 weeks
alanine transaminase (ALT)
alanine transaminase (ALT)
Measured: change from baseline after 4 weeks
gamma-glutamyltransferase
gamma-glutamyltransferase (gGT)
Measured: change from baseline after 4 weeks
Lactate dehydrogenase
Lactate dehydrogenase (LDH)
Measured: change from baseline after 4 weeks
cholinesterase
cholinesterase
Measured: change from baseline after 4 weeks
kalium
kalium (mmol/l)
Measured: change from baseline after 4 weeks
transferrin
transferrin (g/l)
Measured: change from baseline after 4 weeks
ferritin
ferritin (µg/l)
Measured: change from baseline after 4 weeks
bioelectrical impedance
body water, body fat, lean body mass, extracellular mass (ECM), body cell mass (BCM)
Measured: change from baseline after 4 weeks
vitamin A
vitamin A (mmol/l)
Measured: change from baseline after 4 weeks
vitamin D
vitamin A (nmol/l)
Measured: change from baseline after 4 weeks
vitamin E
vitamin E (µmol/l)
Measured: change from baseline after 4 weeks
vitamin B1
vitamin B1 (nmol/l)
Measured: change from baseline after 4 weeks
vitamin B6
vitamin B6 (nmol/l)
Measured: change from baseline after 4 weeks
vitamin B12
vitamin B12 (pmol/l)
Measured: change from baseline after 4 weeks
vitamin B12 status
holotranscobalamine (pmol/l)
Measured: change from baseline after 4 weeks
creatinine
creatinine (mmol/24 h)
Measured: change from baseline after 4 weeks
natrium
natrium (mmol/24 h)
Measured: change from baseline after 4 weeks
magnesium
magnesium (mmol/24 h)
Measured: change from baseline after 4 weeks
zinc
zinc (µmol/24 h)
Measured: change from baseline after 4 weeks
albumine
albumine (mg/l) (24 h urine)
Measured: change from baseline after 4 weeks
uric acid
uric acid (mg/dl) (24 h urine)
Measured: change from baseline after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start29 Oct 2019
- Primary completion16 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Dawczynski,PhD, University of Jena
- Investigators
- Christine Dawczynski, PhD, Principal investigator, University of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113837
- Sponsor's protocol ID
- H9_19
- Status last verified
- Sep 2019
- First submitted
- 1 Oct 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intervention Study for Validating the Influence of Regular Consumption of Foods With Improved Nutrient Profile on Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04113837
- Acronym / sponsor ID
- H9_19
- Conditions
- Cardiovascular Risk Factor
- Keywords
- foods, nutrient profile, dietary fiber, omega 3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| verum | Experimental | Dietary Supplement: food rangeThe 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) |
| control | Active comparator | Dietary Supplement: food rangeIn 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food rangeThe 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 | Dietary supplement | control, verum |
Primary outcome
LDL cholesterol
Time frame: change from baseline after 4 weeks
cardiovascular risk factor
34 secondary outcomes
blood lipids
Time frame: change from baseline after 4 weeks
anthropometric data
Time frame: change from baseline after 4 weeks
blood pressure
Time frame: change from baseline after 4 weeks
lipoprotein a
Time frame: change from baseline after 4 weeks
high-sensitive c-reactive protein
Time frame: change from baseline after 4 weeks
homocysteine
Time frame: change from baseline after 4 weeks
apolipoproteins
Time frame: change from baseline after 4 weeks
glucose (fasting)
Time frame: change from baseline after 4 weeks
insulin (fasting)
Time frame: change from baseline after 4 weeks
hemoglobin A1c (fasting)
Time frame: change from baseline after 4 weeks
malodialdehyde modified LDL cholesterol
Time frame: change from baseline after 4 weeks
fatty acid distribution in plasma lipids
Time frame: change from baseline after 4 weeks
aspartate transaminase (AST)
Time frame: change from baseline after 4 weeks
alanine transaminase (ALT)
Time frame: change from baseline after 4 weeks
gamma-glutamyltransferase
Time frame: change from baseline after 4 weeks
Lactate dehydrogenase
Time frame: change from baseline after 4 weeks
cholinesterase
Time frame: change from baseline after 4 weeks
kalium
Time frame: change from baseline after 4 weeks
transferrin
Time frame: change from baseline after 4 weeks
ferritin
Time frame: change from baseline after 4 weeks
bioelectrical impedance
Time frame: change from baseline after 4 weeks
vitamin A
Time frame: change from baseline after 4 weeks
vitamin D
Time frame: change from baseline after 4 weeks
vitamin E
Time frame: change from baseline after 4 weeks
vitamin B1
Time frame: change from baseline after 4 weeks
vitamin B6
Time frame: change from baseline after 4 weeks
vitamin B12
Time frame: change from baseline after 4 weeks
vitamin B12 status
Time frame: change from baseline after 4 weeks
creatinine
Time frame: change from baseline after 4 weeks
natrium
Time frame: change from baseline after 4 weeks
magnesium
Time frame: change from baseline after 4 weeks
zinc
Time frame: change from baseline after 4 weeks
albumine
Time frame: change from baseline after 4 weeks
uric acid
Time frame: change from baseline after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- recruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Dawczynski, PhD principal investigator
University of Jena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food range in people with Cardiovascular Risk Factor, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL cholesterol (time frame: change from baseline after 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.