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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
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The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by adequate energy intake, intake of carbohydrates, protein and fat according to the guidelines of the German Society of Nutrition (DGE e. V.), with special focus on fat quality of the foods.
Half of the participants will consume additional n-3 long-chain (LC)-PUFA (3 g eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA)/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).
The interventional study will evaluate effectiveness and potential of a 'cardioprotective diet' for adults with increased risk for cardiovascular diseases (CVD). The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.
Half of the participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d). The study participants receive defined personal nutritional counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 weeks (follow-up 20 weeks).
Besides the personal dialogues participants receive information materials providing the dietary recommendations, information to improve nutritional behavior and environment as well as various practical advices. Additionally, a weekly reminder strengthens the approach in addition to each visit at a 2-week interval.
The reflection about the implementation of the advices within day-to-day routine and the resulting challenges are an important part of the concept (feedback).
The identification of variables influencing people's nutritional behavior is attained and offers the possibility to address these variables within the recommendations that will be developed for adults with increased CVD risk as part of our nutriCARD strategy (Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany).
The study will provide data about the association between the defined dietary intake and measurable markers reflecting food intake (nutritional biomarkers) as well as expression of cardiovascular biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardioprotective diet | Experimental | The study participants receive defined personal nutrition counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 wks (follow-up 20 wks). |
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| Cardioprotective diet + 3 g EPA+DHA/d | Experimental | The study participants receive defined personal nutrition counselling every two weeks and they get daily menu plans (with optimised nutrient profiles) over an entire period of 20 wks (follow-up 20 wks). Participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardioprotective diet | Dietary Supplement | The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity. |
| Measure | Description | Time Frame |
|---|---|---|
| blood lipids | total cholesterol, LDL cholesterol, HDL cholesterol, triacylglycerides (TAG) [mmol/L] | change from baseline at 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fatty acid distribution (blood) | Fatty acid distribution in plasma lipids und erythrocyte lipids [% FAME (fatty acid methyl ester)] | change from baseline at 20 weeks |
| insulin (blood) | [units/ml] |
| Measure | Description | Time Frame |
|---|---|---|
| apolipoproteins (blood) | apolipoprotein A1, apolipoprotein B [g/l] | change from baseline at 20 weeks |
| adiponectin (blood) | [mg/l] | change from baseline at 20 weeks |
Inclusion Criteria:
- LDL cholesterol ≥ 3 mmol/L
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Dawczynski, PhD | University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany | Principal Investigator |
| Stefan Lorkowski, PhD | University oj Jena, Department of Nutritional Biochemistry and Physiology; Competence Cluster for Nutrition and Cardiovascular Health (nutriCARD), Halle-Jena-Leipzig, Germany | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40057729 | Derived | Dawczynski C, Drobner T, Weidauer T, Schlattmann P, Kiehntopf M, Weber D, Grune T, Marz W, Kleber ME, Lorkowski S. Reduction of cardiovascular risk factors by the diet - Evaluation of the MoKaRi concept by a parallel-designed randomized study. Lipids Health Dis. 2025 Mar 8;24(1):88. doi: 10.1186/s12944-025-02500-1. | |
| 33997459 | Derived |
| Label | URL |
|---|---|
| Study protocoll | View source |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| Cardioprotective diet + 3 g EPA + DHA/d | Dietary Supplement | The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.The participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d) |
|
| change from baseline at 20 weeks |
| HbA1c (blood) | change from baseline at 20 weeks |
| oral glucose tolerance test (blood) | blood glucose (timepoints: 0, 60 min, 120 min) after oral challenge (75 g glucose) [mmol/l] | change from baseline at 20 weeks |
| alpha prothrombin time (blood) | [sec] | change from baseline at 20 weeks |
| fibrinogen (blood) | [g/l] | change from baseline at 20 weeks |
| Nutritional status I (blood) | vitamins (A, E), folic acid, iodine [µg/l] | change from baseline at 20 weeks |
| Nutritional status II (blood) | vitamin D, vitamin B12 [pg/ml] | change from baseline at 20 weeks |
| Nutritional status III (blood) | vitamin B1, B6 [ng/ml] | change from baseline at 20 weeks |
| homocysteine (blood) | [µmmol/l] | change from baseline at 20 weeks |
| high sensitive c-reactive protein (blood) | [mg/dl] | change from baseline at 20 weeks |
| lipoprotein(a) (blood) | [mg/dl] | change from baseline at 20 weeks |
| height | [m] | change from baseline at 20 weeks |
| weight | [kg] | change from baseline at 20 weeks |
| leptin, resistin (blood) | [µg/l] | change from baseline at 20 weeks |
| creatinine (24h urine) | [mmol/24h] | change from baseline at 20 weeks |
| albumin (24h urine) | [mg/dl] | change from baseline at 20 weeks |
| Nutritional status IV (24h urine) | natrium, magnesium (24h urine) [mmol/24h] | change from baseline at 20 weeks |
| Nutritional status V (24h urine) | copper (24h urine) [µg/g creatinine] | change from baseline at 20 weeks |
| Nutritional status VI (24h urine) | manganese (24h urine) [µg/l] | change from baseline at 20 weeks |
| Dawczynski C, Cullen PM, Schlattmann P, Lorkowski S. A study protocol of a randomized trial evaluating the effect of using defined menu plans within an intensive personal nutritional counseling program on cardiovascular risk factors: The MoKaRi (modulation of cardiovascular risk factors) trial. Contemp Clin Trials Commun. 2021 Apr 29;22:100761. doi: 10.1016/j.conctc.2021.100761. eCollection 2021 Jun. |
| Study results | View source |