NCT02099968

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

March 26, 2014

Last Update Submit

July 8, 2019

Conditions

HypertensionMetabolic Syndrome

Outcome Measures

Primary Outcomes (2)

  • Systolic blood pressure

    24-hour ambulatory blood pressure

    3 months

  • HOMA Index

    Homeostatic Model Assessment

    3 months

Secondary Outcomes (37)

  • Blood pressure

    3 months, 6 months, 12 months

  • Blood pressure

    1 week, 3 months, 6 months, 12 months

  • Pulse wave velocity

    3 months, 6 months, 12 months

  • PROCAM

    1 week, 3 months, 6 months, 12 months

  • SCORE

    1 week, 3 months, 6 months, 12 months

  • +32 more secondary outcomes

Study Arms (2)

Comprehensive Lifestyle Modification

EXPERIMENTAL
Behavioral: Comprehensive Lifestyle Modification

Standard Lifestyle Modification / modified DASH

ACTIVE COMPARATOR
Behavioral: Standard Lifestyle Modification / modified DASH

Interventions

Comprehensive Lifestyle ModificationBEHAVIORAL

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

Comprehensive Lifestyle Modification
Standard Lifestyle Modification / modified DASHBEHAVIORAL

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

Standard Lifestyle Modification / modified DASH

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypertension or antihypertensive medication or subclinical atherosclerosis
  • Metabolic syndrome
  • Basic mobility

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Immanuel Hospital Berlin, Department of Internal and Complementary Medicine

Berlin, 45276, Germany

Location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, 45276, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33785752DERIVED

MeSH Terms

Conditions

HypertensionMetabolic Syndrome

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

March 26, 2014

First Posted

March 31, 2014

Study Start

April 1, 2014

Primary Completion

March 1, 2015

Study Completion

December 1, 2015

Last Updated

July 10, 2019

Record last verified: 2019-07

Locations

DE(2)