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Completed

NCT Number: NCT02099968

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Immanuel Hospital Berlin, Department of Internal and Complementary Medicine, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Lifestyle Modification

Behavioral
  • Fasting (1st week), followed by:
  • Vegetarian and modified DASH diet (plant-based, low-salt)
  • Aerobic exercise
  • Stress reduction techniques: progressive muscle relaxation, meditation, yoga

Standard Lifestyle Modification / modified DASH

Behavioral
  • Modified DASH (vegetarian focused, plant-based, low-salt)
  • Aerobic exercise
  • Stress reduction techniques: progressive muscle relaxation

Primary outcomes

  1. Systolic blood pressure

    Time frame: 3 months

    24-hour ambulatory blood pressure

  2. HOMA Index

    Time frame: 3 months

    Homeostatic Model Assessment

Secondary outcomes

  1. Blood pressure

    Time frame: 3 months, 6 months, 12 months

    24-hour ambulatory blood pressure

  2. Blood pressure

    Time frame: 1 week, 3 months, 6 months, 12 months

    Sphygmomanometer

  3. Pulse wave velocity

    Time frame: 3 months, 6 months, 12 months

    Pulse wave velocity (PWV) is a measure of arterial stiffness

  4. PROCAM

    Time frame: 1 week, 3 months, 6 months, 12 months

    PROCAM risk score

  5. SCORE

    Time frame: 1 week, 3 months, 6 months, 12 months

    SCORE risk score

  6. Waist circumference

    Time frame: 1 week, 3 months, 6 months, 12 months

  7. Weight

    Time frame: 1 week, 3 months, 6 months, 12 months

  8. Blood glucose level

    Time frame: 1 week, 3 months, 6 months, 12 months

  9. Blood insulin level

    Time frame: 1 week, 3 months, 6 months, 12 months

  10. HbA1C

    Time frame: 3 months, 6 months, 12 months

    Longterm parameter for plasma glucose concentration.

  11. Blood creatinine level

    Time frame: 1 week, 3 months, 6 months, 12 months

  12. Total cholesterol

    Time frame: 1 week, 3 months, 6 months, 12 months

  13. LDL cholesterol

    Time frame: 1 week, 3 months, 6 months, 12 months

  14. HDL cholesterol

    Time frame: 1 week, 3 months, 6 months, 12 months

  15. Medication use

    Time frame: 1 week, 3 months, 6 months, 12 months

  16. HADS

    Time frame: 1 week, 3 months, 6 months, 12 months

    Hospital Anxiety and Depression Scale

  17. POMS

    Time frame: 1 week, 3 months, 6 months, 12 months

    Profile of Mood States

  18. CPSS

    Time frame: 3 months, 6 months, 12 months

    Cohen Perceived Stress Scale

  19. SWE

    Time frame: 1 week, 3 months, 6 months, 12 months

    General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)

  20. SF-36

    Time frame: 3 months, 6 months, 12 months

    Health-related quality of life

  21. MAAS

    Time frame: 3 months, 6 months, 12 months

    Mindfulness Attention Awareness Scale

  22. SCS

    Time frame: 1 week, 3 months, 6 months, 12 months

    Self-Compassion Scale

  23. Lifestyle questionnaire

    Time frame: 3 months, 6 months, 12 months

    Questionnaire on physical activity, stress management, diet

  24. Hair steroid analysis

    Time frame: 6 months, 12 months

    Assessment of long-term glucocorticoid levels in scalp hair.

  25. Bioelectrical impedance analysis

    Time frame: 1 week, 3 months, 6 months, 12 months

    Method for estimating body composition (body fat).

  26. Waist/hip ratio

    Time frame: 1 week, 3 months, 6 months, 12 months

  27. Immunophenotyping

    Time frame: 1 week, 3 months, 6 months

    Assessment of immunological subsets in PBMCs

  28. Intestinal microbiota

    Time frame: 1 week, 3 months, 6 months

    Characterization of gut microbiota.

  29. Metabolomics

    Time frame: 1 week, 3 months

    Assessment of small-molecule metabolite profiles from capillary blood

  30. Gene expression profiling

    Time frame: 1 week, 3 months

    Assessment of gene expression profiles from PBMCs.

  31. Interleukin- 6

    Time frame: 1 week, 3 months, 6 months, 12 months

  32. CRP

    Time frame: 1 week, 3 months, 6 months, 12 months

  33. Uric acid

    Time frame: 1 week, 3 months, 6 months, 12 months

  34. Insulin-like growth factor (IGF-1)

    Time frame: 1 week, 3 months, 6 months, 12 months

  35. Adverse events

    Time frame: 1 week, 3 months, 6 months, 12 months

    Adverse events

  36. Framingham-Score

    Time frame: 1 week, 3 months, 6 months, 12 months

  37. JBS3-Score

    Time frame: 1 week, 3 months, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Charite University, Berlin, Germany
  • Immanuel Hospital, Berlin, Germany
  • Kliniken Essen-Mitte
  • University of Witten/Herdecke

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 31, 2014
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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