Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial

Study Overview
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Brief Summary
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Different forms of diet, e.g. Mediterranean diet, DASH diet, or fasting, have demonstrated efficacy in reducing elevated blood pressure. Moreover, Mediterranean diet, and fasting seem to be effective in improving insulin sensitivity in type 2 diabetes. Further, studies on meditation or mindfulness-based interventions have shown positive effects in patients with hypertension and/or type 2 diabetes. Comprehensive Lifestyle Modification, this is a combination of diet, exercise, and stress management, have improved coronary atherosclerosis. However, no studies have yet investigated the effects of Comprehensive Lifestyle Modification in patients with metabolic syndrome and/or in combination with fasting therapy. This study is supported by a grant from the Corona-Foundation, Germany.

Official Title
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Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate

Conditions
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Hypertension, Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Comprehensive Lifestyle Modification
* Behavioral: Standard Lifestyle Modification / modified DASH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertension or antihypertensive medication or subclinical atherosclerosis Metabolic syndrome Basic mobility Exclusion Criteria: Diabetes type 1 Insulin bolus therapy Coronary artery disease Myocardial infarct, pulmonary embolism, or stroke within the past 3 months Heart failure Peripheral vascular disease Chronic kidney disease Eating disorder Dementia Other severe internal disease

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Comprehensive Lifestyle Modification<br> | Behavioral: Comprehensive Lifestyle Modification<br>* Fasting (1st week), followed by: Vegetarian and modified DASH diet (plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation, meditation, yoga<br>|
| Active Comparator: Standard Lifestyle Modification / modified DASH<br> | Behavioral: Standard Lifestyle Modification / modified DASH<br>* Modified DASH (vegetarian focused, plant-based, low-salt) Aerobic exercise Stress reduction techniques: progressive muscle relaxation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | 24-hour ambulatory blood pressure | 3 months | 
| HOMA Index | Homeostatic Model Assessment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | 24-hour ambulatory blood pressure | 3 months, 6 months, 12 months | 
| Blood pressure | Sphygmomanometer | 1 week, 3 months, 6 months, 12 months | 
| Pulse wave velocity | Pulse wave velocity (PWV) is a measure of arterial stiffness | 3 months, 6 months, 12 months | 
| PROCAM | PROCAM risk score | 1 week, 3 months, 6 months, 12 months | 
| SCORE | SCORE risk score | 1 week, 3 months, 6 months, 12 months | 
| Waist circumference |  | 1 week, 3 months, 6 months, 12 months | 
| Weight |  | 1 week, 3 months, 6 months, 12 months | 
| Blood glucose level |  | 1 week, 3 months, 6 months, 12 months | 
| Blood insulin level |  | 1 week, 3 months, 6 months, 12 months | 
| HbA1C | Longterm parameter for plasma glucose concentration. | 3 months, 6 months, 12 months | 
| Blood creatinine level |  | 1 week, 3 months, 6 months, 12 months | 
| Total cholesterol |  | 1 week, 3 months, 6 months, 12 months | 
| LDL cholesterol |  | 1 week, 3 months, 6 months, 12 months | 
| HDL cholesterol |  | 1 week, 3 months, 6 months, 12 months | 
| Medication use |  | 1 week, 3 months, 6 months, 12 months | 
| HADS | Hospital Anxiety and Depression Scale | 1 week, 3 months, 6 months, 12 months | 
| POMS | Profile of Mood States | 1 week, 3 months, 6 months, 12 months | 
| CPSS | Cohen Perceived Stress Scale | 3 months, 6 months, 12 months | 
| SWE | General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung) | 1 week, 3 months, 6 months, 12 months | 
| SF-36 | Health-related quality of life | 3 months, 6 months, 12 months | 
| MAAS | Mindfulness Attention Awareness Scale | 3 months, 6 months, 12 months | 
| SCS | Self-Compassion Scale | 1 week, 3 months, 6 months, 12 months | 
| Lifestyle questionnaire | Questionnaire on physical activity, stress management, diet | 3 months, 6 months, 12 months | 
| Hair steroid analysis | Assessment of long-term glucocorticoid levels in scalp hair. | 6 months, 12 months | 
| Bioelectrical impedance analysis | Method for estimating body composition (body fat). | 1 week, 3 months, 6 months, 12 months | 
| Waist/hip ratio |  | 1 week, 3 months, 6 months, 12 months | 
| Immunophenotyping | Assessment of immunological subsets in PBMCs | 1 week, 3 months, 6 months | 
| Intestinal microbiota | Characterization of gut microbiota. | 1 week, 3 months, 6 months | 
| Metabolomics | Assessment of small-molecule metabolite profiles from capillary blood | 1 week, 3 months | 
| Gene expression profiling | Assessment of gene expression profiles from PBMCs. | 1 week, 3 months | 
| Interleukin- 6 |  | 1 week, 3 months, 6 months, 12 months | 
| CRP |  | 1 week, 3 months, 6 months, 12 months | 
| Uric acid |  | 1 week, 3 months, 6 months, 12 months | 
| Insulin-like growth factor (IGF-1) |  | 1 week, 3 months, 6 months, 12 months | 
| Adverse events | Adverse events | 1 week, 3 months, 6 months, 12 months | 
| Framingham-Score |  | 1 week, 3 months, 6 months, 12 months | 
| JBS3-Score |  | 1 week, 3 months, 6 months, 12 months |