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

NCT02099968 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2019-07-10

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Comprehensive 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

BEHAVIORAL

Standard Lifestyle Modification / modified DASH

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

Sponsors & Collaborators

  • Kliniken Essen-Mitte

    collaborator OTHER

  • Immanuel Hospital Berlin, Berlin, Germany

    collaborator UNKNOWN

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Witten/Herdecke

    collaborator OTHER

  • Universität Duisburg-Essen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-03-31
Completion
2015-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099968 on ClinicalTrials.gov