Hypertension, Metabolic Syndrome
Conditions
Brief summary
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.
Interventions
BEHAVIORALComprehensive Lifestyle Modification
* Fasting (1st week), followed by: * Vegetarian and modified DASH diet (plant-based, low-salt) * Aerobic exercise * Stress reduction techniques: progressive muscle relaxation, meditation, yoga
BEHAVIORALStandard Lifestyle Modification / modified DASH
* Modified DASH (vegetarian focused, plant-based, low-salt) * Aerobic exercise * Stress reduction techniques: progressive muscle relaxation
Sponsors
Kliniken Essen-Mitte
Immanuel Hospital Berlin, Berlin, Germany
Charite University, Berlin, Germany
University of Witten/Herdecke
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure | 3 months | 24-hour ambulatory blood pressure |
| HOMA Index | 3 months | Homeostatic Model Assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose level | 1 week, 3 months, 6 months, 12 months | — |
| Blood pressure | 3 months, 6 months, 12 months | 24-hour ambulatory blood pressure |
| Pulse wave velocity | 3 months, 6 months, 12 months | Pulse wave velocity (PWV) is a measure of arterial stiffness |
| PROCAM | 1 week, 3 months, 6 months, 12 months | PROCAM risk score |
| SCORE | 1 week, 3 months, 6 months, 12 months | SCORE risk score |
| Waist circumference | 1 week, 3 months, 6 months, 12 months | — |
| HbA1C | 3 months, 6 months, 12 months | Longterm parameter for plasma glucose concentration. |
| 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 | 1 week, 3 months, 6 months, 12 months | Hospital Anxiety and Depression Scale |
| POMS | 1 week, 3 months, 6 months, 12 months | Profile of Mood States |
| CPSS | 3 months, 6 months, 12 months | Cohen Perceived Stress Scale |
| SWE | 1 week, 3 months, 6 months, 12 months | General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung) |
| SF-36 | 3 months, 6 months, 12 months | Health-related quality of life |
| Blood insulin level | 1 week, 3 months, 6 months, 12 months | — |
| SCS | 1 week, 3 months, 6 months, 12 months | Self-Compassion Scale |
| Lifestyle questionnaire | 3 months, 6 months, 12 months | Questionnaire on physical activity, stress management, diet |
| Hair steroid analysis | 6 months, 12 months | Assessment of long-term glucocorticoid levels in scalp hair. |
| Bioelectrical impedance analysis | 1 week, 3 months, 6 months, 12 months | Method for estimating body composition (body fat). |
| Waist/hip ratio | 1 week, 3 months, 6 months, 12 months | — |
| Immunophenotyping | 1 week, 3 months, 6 months | Assessment of immunological subsets in PBMCs |
| Intestinal microbiota | 1 week, 3 months, 6 months | Characterization of gut microbiota. |
| Metabolomics | 1 week, 3 months | Assessment of small-molecule metabolite profiles from capillary blood |
| Gene expression profiling | 1 week, 3 months | Assessment of gene expression profiles from PBMCs. |
| 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 | 1 week, 3 months, 6 months, 12 months | Adverse events |
| Framingham-Score | 1 week, 3 months, 6 months, 12 months | — |
| JBS3-Score | 1 week, 3 months, 6 months, 12 months | — |
| MAAS | 3 months, 6 months, 12 months | Mindfulness Attention Awareness Scale |
| Weight | 1 week, 3 months, 6 months, 12 months | — |
Countries
Germany
Outcome results
None listed