NCT02099968

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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

• Hypertension
• Metabolic Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-03-01
• Completion: 2015-12-01
• First posted: 2014-03-31
• Last updated: 2019-07-10

Locations

2 sites across 1 country: Germany