Long-term effects of a food pattern on cardiovascular risk factors and age-related changes of muscular and cognitive function

Conditions

Muscle strength and muscle mass I10.9 I50.9 I25.1 I25.29 I51.6 R29.6 F06.9 I64

Sebastian Brachs, Dominik Soll, Finja Beer, Nadine Huckauf, Anish Konkar et al. (8 authors)

European Journal of Endocrinology2025-02-014 citations

Increase in PUFA and protein, and decrease in carbohydrate intake improves liver fat in 12 months and the role of weight loss as a mediator: A randomized controlled trial

Laura Pletsch‐Borba, Charlotte Wernicke, Jürgen Machann, Nina Marie Tosca Meyer, Thu Huong Nguyen et al. (11 authors)

Clinical Nutrition2024-11-14

10.1016/j.clnu.2024.11.010

Effect of unsaturated fat and protein intake on liver fat in people at risk of unhealthy aging: 1-year results of a randomized controlled trial.

Wernicke C, Pohrt A, Pletsch-Borba L, Apostolopoulou K, Hornemann S, Meyer N, Machann J, Gerbracht C, Tacke F, Pfeiffer AF, Spranger J, Mai K.

2023-01-139 citations

10.1016/j.ajcnut.2023.01.010

Nutritional counseling frequency and baseline food pattern predict implementation of a high-protein and high-polyunsaturated fatty acid dietary pattern: 1-year results of the randomized NutriAct trial.

Pletsch-Borba L, Wernicke C, Apostolopoulou K, Spira D, Pohrt A, Hornemann S, Gerbracht C, Pfeiffer AFH, Spranger J, Mai K.

2021-09-256 citations

10.1016/j.clnu.2021.09.022

Interventions

Group 1: Intervention Group (250 Probands): 3 years of consuming the NutriAct Food Pattern, which will be composed of: a) 35-40% fat (a reduced supply of saturated fatty acids will be achieved by repl

Eligibility

Sex/Gender

All

Age

50 Years to 80 Years

Inclusion criteria

Inclusion criteria: At least one of the following criteria: •Heart failure (NT-Pro-BNP >300ng/l) •NYHA =II •Cardiovascular disease (Blood pressure, stroke, heart infarction) •Cognitive Impairment (Moca-Score <26) •reduced of muscle strength (SPPB-Score <10)

Exclusion criteria

Exclusion criteria: •Instabile coronary heart disease •Blood pressure values > 180 mmHg systolic and/or 110 mmHg diastolic •Gait disturbance diseases for example Parkinson, Stroke with paresis •endoprothesis •Diabetes mellitus Typ 1 •Probands with Typ 2 Diabetes under Insulintherapy •Severe hepatic and/ or kidney disease (raise of aminotransferase levels up to 3 times above the normal value and/or eGFR < 50 ml/min/1,73 m²) •Severe symptomatic malignancy •Severe systemic infection •Severe mental illness •Severe imunne disease •Severe food allergy •Severe malabsorption disease •Oral steroid therapy • not treated endocrine disease •Drugs and/or alcohol abuse •Eating disorders •potentially unreliable probands • participation in other study • no health insurance

Design outcomes

Primary

Measure	Time frame
Composite Endpoint consisting of cardiovascular morbidity (heart failure or coronary heart disease or revascularization or heart infarction or stroke or deterioriation of the blood pressure) or age-related changes (muscle strength or muscle mass or impairment of cognitive function). Here it should be proved that this intervention will lead to a lesser deterioration of at least one of the Endpoints. In detail, cardiovascular disease: anamnesis (heart failure or coronary heart disease or revascularization or heart infarction or stroke ), blood pressure, control of the cardiovascular capacity: echocardiography (LVEF) baseline, after 1y and after 3y, hospitalization for heart failure. Muscle strength and mass (SPPB, hand grip strength and dual-energy X-ray absorptiometry) at baseline, after 1y and 3y Cognitive Function: [CERAD (TMT-A), WMS (digit span), Stroop (Wolfram)]: at baseline, after 1y and 3y	—

Measure

Time frame

Composite Endpoint consisting of cardiovascular morbidity (heart failure or coronary heart disease or revascularization or heart infarction or stroke or deterioriation of the blood pressure) or age-related changes (muscle strength or muscle mass or impairment of cognitive function). Here it should be proved that this intervention will lead to a lesser deterioration of at least one of the Endpoints. In detail, cardiovascular disease: anamnesis (heart failure or coronary heart disease or revascularization or heart infarction or stroke ), blood pressure, control of the cardiovascular capacity: echocardiography (LVEF) baseline, after 1y and after 3y, hospitalization for heart failure. Muscle strength and mass (SPPB, hand grip strength and dual-energy X-ray absorptiometry) at baseline, after 1y and 3y Cognitive Function: [CERAD (TMT-A), WMS (digit span), Stroop (Wolfram)]: at baseline, after 1y and 3y

—

Secondary

Measure	Time frame
Longterm Effects of a Food Pattern on: •the distribution of intraabdominal, intrahepatic and intramuscular adipose tissue: MRI and Spectroscopy,:Baseline, after 1y and 3y •change of insulin sensitivity: OGTT at baseline, after 6,12,24,36 months •changes of visceral fat and muscle mass (DEXA at baselinie, 1 and 3 yrs , Tissue specific Change of mRNA and Protein Expression in adippose tissue biopsies at baseline, after 1y and 3y cardiovascular function (echocardiography, 6 Minute walk test, ABI) and development of heart failure • coronary heart disease •Revascularization •Myocardial infarction •Stroke •Blood pressure Muscle strength (SPPB, Hand grip, NIH tool box (subgroup) frailty score •Cognitive function (CERAD Plus, digit span(WMS-R), Stroop test) microbiome Body composition (DEXA) bone density (DEXA, subgroup) Energy expenditure and subtrate utilization (calorimetry) physical activity (accelerometry) hormonal, metabolic and inflammatory changes dietary pattern adherence to the Intervention Depression QoL This includes numerous questionnaires (baseline, after 6 months (V2), after 12 months (V3), after 24 months (V4) and after36 months (V5): Eating behavior and lifestyle habits Quality of life and measure of health Status: SF36 and Promis29 cardial function: Minnesota Living with Heart failure Questionnaire QoL Score Depression and generalized Anxiety Disorder:PHQ-9,GAD-7, SWOP-9 und FAH-II	—

Measure

Time frame

Longterm Effects of a Food Pattern on: •the distribution of intraabdominal, intrahepatic and intramuscular adipose tissue: MRI and Spectroscopy,:Baseline, after 1y and 3y •change of insulin sensitivity: OGTT at baseline, after 6,12,24,36 months •changes of visceral fat and muscle mass (DEXA at baselinie, 1 and 3 yrs , Tissue specific Change of mRNA and Protein Expression in adippose tissue biopsies at baseline, after 1y and 3y cardiovascular function (echocardiography, 6 Minute walk test, ABI) and development of heart failure • coronary heart disease •Revascularization •Myocardial infarction •Stroke •Blood pressure Muscle strength (SPPB, Hand grip, NIH tool box (subgroup) frailty score •Cognitive function (CERAD Plus, digit span(WMS-R), Stroop test) microbiome Body composition (DEXA) bone density (DEXA, subgroup) Energy expenditure and subtrate utilization (calorimetry) physical activity (accelerometry) hormonal, metabolic and inflammatory changes dietary pattern adherence to the Intervention Depression QoL This includes numerous questionnaires (baseline, after 6 months (V2), after 12 months (V3), after 24 months (V4) and after36 months (V5): Eating behavior and lifestyle habits Quality of life and measure of health Status: SF36 and Promis29 cardial function: Minnesota Living with Heart failure Questionnaire QoL Score Depression and generalized Anxiety Disorder:PHQ-9,GAD-7, SWOP-9 und FAH-II

—

Countries

Germany

Contacts

Public ContactCharlotte Wernicke

Medizinische Klinik für Endokrinologie, Diabetes und Ernährungsmedizin, Charité Universitätsmedizin

charlotte.wernicke@charite.de004930450614218

Outcome results

None listed