Decreased Cardovascular RiskMoKaRi IINCT05382533
MoKaRi II Intervention Study
A study testing Menu plans in people with Decreased Cardovascular Risk and Decreased Risk of Diabetes Mellitus Type II, run by University of Jena at 1 site in Germany.
Trial summary
The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7 mmol/l). Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Decreased Cardovascular Risk, Decreased Risk of Diabetes Mellitus Type II
- What is being tested?
- Menu plans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to 14 Dec 2022
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary participation with documented consent
- Willingness and ability to adhere to study protocol
- Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
- BMI: ≥ 20 ≤ 40 kg/m2
- No or moderate alcohol consumption (≤ 2 glasses/week)
- non-smoker (if possible)
- Group A, B: triglycerides: > 1.5 mmol/l
- Group C, D: Fasting glucose: ≥ 5.6 ≤ 7 mmol/L
Who cannot join
- Concomitant diseases:
- Hypercholesterolemia (genetic defect / familial predisposition)
- Diabetes mellitus
- Thyroid dysfunction (hyper- or hypothyroidism)
- Food intolerances/allergies to ingredients in the study foods
- Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
Show all 16Show fewer
- Dietary supplements: especially n-3 fatty acids, vitamin E
- Extremely high physical activity (daily)
- Alcohol abuse (daily)
- (smokers) [if there are not enough subjects available, at least 7 smokers should be included so that a statistical analysis is possible]
- Uncontrolled organic diseases
- Alcohol, medication or drug abuse
- Participation in other observational clinical studies during or 4 wk. before starting this study
- Severe behavioral, emotional, or psychiatric problems that the investigator determined would result in non-compliance
- Pregnancy, lactation and unsafe contraception
- Other reasons considered important by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
The proposed intervention study addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7 mmol/l).
Read the detailed description
The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance (glucose > 5.6 ≤ 7 mmol/l).
The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D).
The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products.
Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D).
The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.
- Being tested
- Menu plans
- Keywords
- triacylglcerides, glucose, HbA1c, body weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menu plansDietary supplement
The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Hypertriglyceridemia intervention (group A) | Experimental | * Carbohydrates: ≤ 50 en% (sucrose + glucose + fructose ≤ 10 en%, where sucrose ≤ 5 en% and fructose ≤ 20 g/d)
* Fat: 30-35 En%
* Protein: 20 En%
* marine n3 PUFA (EPA/DHA): ≥ 4000 mg/d (10 g fish oil) Receives: Dietary Supplement: Menu plans |
| Hypertriglyceridemia control (group B) | No intervention | no menu plans, no study foods |
| Prediabetes intervention (group C) | Experimental | * Carbohydrates: 40 ± 2 En%
* Sucrose + glucose + fructose ≤ 10 En%
* Free sugars < 5% of daily energy
* Fat: 40 ± 2%
* Protein: 20 ± 2 En%
* n3 PUFA: ≥ 500 mg/d Receives: Dietary Supplement: Menu plans |
| Prediabetes control (group D) | No intervention | no menu plans, no study foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triacylglcerides, mmol/l (group A, B)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
Fasting glucose, mmol/l (group C, D)
Diabetes risk factor
Measured: Change from baseline after 10 weeks
Secondary outcomes (28)
Total cholesterol (mmol/l)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
HDL cholesterol (mmol/l)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
LDL cholesterol (mmol/l)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
Systolic pressure (mm Hg)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
Diastolic pressure (mm Hg)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
Insulin (mU/l)
Diabetes risk factor
Measured: Change from baseline after 10 weeks
HbA1c (%)
Diabetes risk factor
Measured: Change from baseline after 10 weeks
Body weight (kg)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
Body fat (kg)
Cardiovascular risk factor
Measured: Change from baseline after 10 weeks
High sensitive c-reactive protein (mg/l)
Inflammatory marker
Measured: Change from baseline after 10 weeks
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)
Fatty acid distribution in erythrocyte lipids
Measured: Change from baseline after 10 weeks
Vitamin A (mmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin D (nmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin E (µmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin B1 (nmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin B6 (nmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin B12 (pmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Holo-transcobalamin (pmol/l)
Vitamins
Measured: Change from baseline after 10 weeks
Folic acid (µg/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin H (ng/l)
Vitamins
Measured: Change from baseline after 10 weeks
Vitamin C (mg/l)
Vitamins
Measured: Change from baseline after 10 weeks
Potassium (mmol/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Iron (µmol/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Ferritin (µg/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Transferrin (g/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Iodine (µmol/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Selenium (µmol/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Zinc (µmol/l)
Minerals and trace elements
Measured: Change from baseline after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start30 May 2022
- Primary completion31 Aug 2022
- Study completion14 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decreased Cardovascular RiskStudies 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
- Parallel groups
- Model description
- parallel design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 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 A Dawczynski, PhD, Principal investigator, Friedrich Schiller University Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382533
- Sponsor's protocol ID
- H13-22
- Acronym
- MoKaRi II
- Status last verified
- Feb 2023
- First submitted
- 16 May 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Cardiovascular Risk II (MoKaRi II) Intervention Study - Modulation of Cardiovascular Risk and Diabetes Risk Using Menu Plans
- ClinicalTrials.gov ID
- NCT05382533
- Acronym / sponsor ID
- MoKaRi II / H13-22
- Keywords
- triacylglcerides, glucose, HbA1c, body weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 19 May 2022 (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 addresses the development and validation of nutritional concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7 mmol/l).
Detailed description
The proposed intervention study addresses the development and validation of nutritional concepts for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants with impaired glucose tolerance (glucose > 5.6 ≤ 7 mmol/l).
The randomized, controlled study will be conducted in a parallel design with four arms. In total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B), prediabetes concept (group C), and prediabetes control (group D).
The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study period of ten weeks. Participants in the control groups B and D are not provided with defined menu plans or study products.
Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks intervention period as well as after the ten-weeks follow-up. Primary endpoints are triglycerides (group A, B), and fasting glucose (group C, D).
The study design enables the comparison of the effectiveness of the developed nutritional concepts, which were adapted to the requirements of the target groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
- Model description
- parallel design
| Arm | Type | Receives |
|---|---|---|
| Hypertriglyceridemia intervention (group A) | Experimental | Dietary Supplement: Menu plans* Carbohydrates: ≤ 50 en% (sucrose + glucose + fructose ≤ 10 en%, where sucrose ≤ 5 en% and fructose ≤ 20 g/d) * Fat: 30-35 En% * Protein: 20 En% * marine n3 PUFA (EPA/DHA): ≥ 4000 mg/d (10 g fish oil) |
| Hypertriglyceridemia control (group B) | No intervention | –no menu plans, no study foods |
| Prediabetes intervention (group C) | Experimental | Dietary Supplement: Menu plans* Carbohydrates: 40 ± 2 En% * Sucrose + glucose + fructose ≤ 10 En% * Free sugars < 5% of daily energy * Fat: 40 ± 2% * Protein: 20 ± 2 En% * n3 PUFA: ≥ 500 mg/d |
| Prediabetes control (group D) | No intervention | –no menu plans, no study foods |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation with documented consent
- Willingness and ability to adhere to study protocol
- Volunteer test person (m/f) aged ≥ 30 years and ≤ 80 years
- BMI: ≥ 20 ≤ 40 kg/m2
- No or moderate alcohol consumption (≤ 2 glasses/week)
Key exclusion criteria (16 listed)
- Hypercholesterolemia (genetic defect / familial predisposition)
- Diabetes mellitus
- Thyroid dysfunction (hyper- or hypothyroidism)
- Food intolerances/allergies to ingredients in the study foods
- Medications: lipid-lowering drugs, glucocorticoids, oral medication for the treatment of type 1-4 diabetes mellitus, insulin injections
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 |
|---|---|---|
| Menu plansThe study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks. | Dietary supplement | Hypertriglyceridemia intervention (group A), Prediabetes intervention (group C) |
Primary outcome
Triacylglcerides, mmol/l (group A, B)
Time frame: Change from baseline after 10 weeks
Cardiovascular risk factor
Fasting glucose, mmol/l (group C, D)
Time frame: Change from baseline after 10 weeks
Diabetes risk factor
28 secondary outcomes
Total cholesterol (mmol/l)
Time frame: Change from baseline after 10 weeks
HDL cholesterol (mmol/l)
Time frame: Change from baseline after 10 weeks
LDL cholesterol (mmol/l)
Time frame: Change from baseline after 10 weeks
Systolic pressure (mm Hg)
Time frame: Change from baseline after 10 weeks
Diastolic pressure (mm Hg)
Time frame: Change from baseline after 10 weeks
Insulin (mU/l)
Time frame: Change from baseline after 10 weeks
HbA1c (%)
Time frame: Change from baseline after 10 weeks
Body weight (kg)
Time frame: Change from baseline after 10 weeks
Body fat (kg)
Time frame: Change from baseline after 10 weeks
High sensitive c-reactive protein (mg/l)
Time frame: Change from baseline after 10 weeks
Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)
Time frame: Change from baseline after 10 weeks
Vitamin A (mmol/l)
Time frame: Change from baseline after 10 weeks
Vitamin D (nmol/l)
Time frame: Change from baseline after 10 weeks
Vitamin E (µmol/l)
Time frame: Change from baseline after 10 weeks
Vitamin B1 (nmol/l)
Time frame: Change from baseline after 10 weeks
Vitamin B6 (nmol/l)
Time frame: Change from baseline after 10 weeks
Vitamin B12 (pmol/l)
Time frame: Change from baseline after 10 weeks
Holo-transcobalamin (pmol/l)
Time frame: Change from baseline after 10 weeks
Folic acid (µg/l)
Time frame: Change from baseline after 10 weeks
Vitamin H (ng/l)
Time frame: Change from baseline after 10 weeks
Vitamin C (mg/l)
Time frame: Change from baseline after 10 weeks
Potassium (mmol/l)
Time frame: Change from baseline after 10 weeks
Iron (µmol/l)
Time frame: Change from baseline after 10 weeks
Ferritin (µg/l)
Time frame: Change from baseline after 10 weeks
Transferrin (g/l)
Time frame: Change from baseline after 10 weeks
Iodine (µmol/l)
Time frame: Change from baseline after 10 weeks
Selenium (µmol/l)
Time frame: Change from baseline after 10 weeks
Zinc (µmol/l)
Time frame: Change from baseline after 10 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 6 Feb 2023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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 A Dawczynski, PhD principal investigator
Friedrich Schiller University 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 Menu plans in people with Decreased Cardovascular Risk and Decreased Risk of Diabetes Mellitus Type II, 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 16 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 6 Feb 2023. 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?
Triacylglcerides, mmol/l (group A, B) (time frame: Change from baseline after 10 weeks). The study lists 2 primary outcomes in all. 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 6 Feb 2023.