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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
145
* Fasting (1st week), followed by: * Vegetarian and modified DASH diet (plant-based, low-salt) * Aerobic exercise * Stress reduction techniques: progressive muscle relaxation, meditation, yoga
* Modified DASH (vegetarian focused, plant-based, low-salt) * Aerobic exercise * Stress reduction techniques: progressive muscle relaxation
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
Berlin, Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, Germany
Systolic blood pressure
24-hour ambulatory blood pressure
Time frame: 3 months
HOMA Index
Homeostatic Model Assessment
Time frame: 3 months
Blood pressure
24-hour ambulatory blood pressure
Time frame: 3 months, 6 months, 12 months
Blood pressure
Sphygmomanometer
Time frame: 1 week, 3 months, 6 months, 12 months
Pulse wave velocity
Pulse wave velocity (PWV) is a measure of arterial stiffness
Time frame: 3 months, 6 months, 12 months
PROCAM
PROCAM risk score
Time frame: 1 week, 3 months, 6 months, 12 months
SCORE
SCORE risk score
Time frame: 1 week, 3 months, 6 months, 12 months
Waist circumference
Time frame: 1 week, 3 months, 6 months, 12 months
Weight
Time frame: 1 week, 3 months, 6 months, 12 months
Blood glucose level
Time frame: 1 week, 3 months, 6 months, 12 months
Blood insulin level
Time frame: 1 week, 3 months, 6 months, 12 months
HbA1C
Longterm parameter for plasma glucose concentration.
Time frame: 3 months, 6 months, 12 months
Blood creatinine level
Time frame: 1 week, 3 months, 6 months, 12 months
Total cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
LDL cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
HDL cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
Medication use
Time frame: 1 week, 3 months, 6 months, 12 months
HADS
Hospital Anxiety and Depression Scale
Time frame: 1 week, 3 months, 6 months, 12 months
POMS
Profile of Mood States
Time frame: 1 week, 3 months, 6 months, 12 months
CPSS
Cohen Perceived Stress Scale
Time frame: 3 months, 6 months, 12 months
SWE
General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Time frame: 1 week, 3 months, 6 months, 12 months
SF-36
Health-related quality of life
Time frame: 3 months, 6 months, 12 months
MAAS
Mindfulness Attention Awareness Scale
Time frame: 3 months, 6 months, 12 months
SCS
Self-Compassion Scale
Time frame: 1 week, 3 months, 6 months, 12 months
Lifestyle questionnaire
Questionnaire on physical activity, stress management, diet
Time frame: 3 months, 6 months, 12 months
Hair steroid analysis
Assessment of long-term glucocorticoid levels in scalp hair.
Time frame: 6 months, 12 months
Bioelectrical impedance analysis
Method for estimating body composition (body fat).
Time frame: 1 week, 3 months, 6 months, 12 months
Waist/hip ratio
Time frame: 1 week, 3 months, 6 months, 12 months
Immunophenotyping
Assessment of immunological subsets in PBMCs
Time frame: 1 week, 3 months, 6 months
Intestinal microbiota
Characterization of gut microbiota.
Time frame: 1 week, 3 months, 6 months
Metabolomics
Assessment of small-molecule metabolite profiles from capillary blood
Time frame: 1 week, 3 months
Gene expression profiling
Assessment of gene expression profiles from PBMCs.
Time frame: 1 week, 3 months
Interleukin- 6
Time frame: 1 week, 3 months, 6 months, 12 months
CRP
Time frame: 1 week, 3 months, 6 months, 12 months
Uric acid
Time frame: 1 week, 3 months, 6 months, 12 months
Insulin-like growth factor (IGF-1)
Time frame: 1 week, 3 months, 6 months, 12 months
Adverse events
Adverse events
Time frame: 1 week, 3 months, 6 months, 12 months
Framingham-Score
Time frame: 1 week, 3 months, 6 months, 12 months
JBS3-Score
Time frame: 1 week, 3 months, 6 months, 12 months
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