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

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 Overview

• Status: Completed
• Conditions: Hypertension; Metabolic Syndrome
• Intervention / Treatment: Behavioral: Comprehensive Lifestyle Modification; Behavioral: Standard Lifestyle Modification / modified DASH

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 45276
    • Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
  • Essen, Germany, 45276
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Comprehensive Lifestyle Modification	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
ACTIVE_COMPARATOR: Standard Lifestyle Modification / modified DASH	Behavioral: Standard Lifestyle Modification / modified DASH; Modified DASH (vegetarian focused, plant-based, low-salt); Aerobic exercise; Stress reduction techniques: progressive muscle relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	24-hour ambulatory blood pressure	3 months
HOMA Index	Homeostatic Model Assessment	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	24-hour ambulatory blood pressure	3 months, 6 months, 12 months
Blood pressure	Sphygmomanometer	1 week, 3 months, 6 months, 12 months
Pulse wave velocity	Pulse wave velocity (PWV) is a measure of arterial stiffness	3 months, 6 months, 12 months
PROCAM	PROCAM risk score	1 week, 3 months, 6 months, 12 months
SCORE	SCORE risk score	1 week, 3 months, 6 months, 12 months
Waist circumference		1 week, 3 months, 6 months, 12 months
Weight		1 week, 3 months, 6 months, 12 months
Blood glucose level		1 week, 3 months, 6 months, 12 months
Blood insulin level		1 week, 3 months, 6 months, 12 months
HbA1C	Longterm parameter for plasma glucose concentration.	3 months, 6 months, 12 months
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	Hospital Anxiety and Depression Scale	1 week, 3 months, 6 months, 12 months
POMS	Profile of Mood States	1 week, 3 months, 6 months, 12 months
CPSS	Cohen Perceived Stress Scale	3 months, 6 months, 12 months
SWE	General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)	1 week, 3 months, 6 months, 12 months
SF-36	Health-related quality of life	3 months, 6 months, 12 months
MAAS	Mindfulness Attention Awareness Scale	3 months, 6 months, 12 months
SCS	Self-Compassion Scale	1 week, 3 months, 6 months, 12 months
Lifestyle questionnaire	Questionnaire on physical activity, stress management, diet	3 months, 6 months, 12 months
Hair steroid analysis	Assessment of long-term glucocorticoid levels in scalp hair.	6 months, 12 months
Bioelectrical impedance analysis	Method for estimating body composition (body fat).	1 week, 3 months, 6 months, 12 months
Waist/hip ratio		1 week, 3 months, 6 months, 12 months
Immunophenotyping	Assessment of immunological subsets in PBMCs	1 week, 3 months, 6 months
Intestinal microbiota	Characterization of gut microbiota.	1 week, 3 months, 6 months
Metabolomics	Assessment of small-molecule metabolite profiles from capillary blood	1 week, 3 months
Gene expression profiling	Assessment of gene expression profiles from PBMCs.	1 week, 3 months
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	Adverse events	1 week, 3 months, 6 months, 12 months
Framingham-Score		1 week, 3 months, 6 months, 12 months
JBS3-Score		1 week, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Charite University, Berlin, Germany; University of Witten/Herdecke; Kliniken Essen-Mitte; Immanuel Hospital Berlin, Berlin, Germany

Publications and helpful links

General Publications

• Maifeld A, Bartolomaeus H, Lober U, Avery EG, Steckhan N, Marko L, Wilck N, Hamad I, Susnjar U, Mahler A, Hohmann C, Chen CY, Cramer H, Dobos G, Lesker TR, Strowig T, Dechend R, Bzdok D, Kleinewietfeld M, Michalsen A, Muller DN, Forslund SK. Fasting alters the gut microbiome reducing blood pressure and body weight in metabolic syndrome patients. Nat Commun. 2021 Mar 30;12(1):1970. doi: 10.1038/s41467-021-22097-0.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (ACTUAL): March 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: March 26, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (ESTIMATE): March 31, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Hypertension; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: CORONA