HypertensionNCT02099968
Comprehensive Lifestyle Modification for Patients With Hypertension and Metabolic Syndrome: a Multicenter Randomized Controlled Trial
A study testing Comprehensive Lifestyle Modification and Standard Lifestyle Modification / modified DASH in people with Hypertension and Metabolic Syndrome, run by Universität Duisburg-Essen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypertension, Metabolic Syndrome
- What is being tested?
- Comprehensive Lifestyle Modification and Standard Lifestyle Modification / modified DASH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertension or antihypertensive medication or subclinical atherosclerosis
- Metabolic syndrome
- Basic mobility
Who cannot join
- 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
Show all 10Show fewer
- Chronic kidney disease
- Eating disorder
- Dementia
- Other severe internal disease
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Immanuel Hospital Berlin, Department of Internal and Complementary Medicine
Berlin, 45276
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, 45276
About this study
Official title: 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.
- Conditions
- Hypertension, Metabolic Syndrome
- Being tested
- Comprehensive Lifestyle Modification, Standard Lifestyle Modification / modified DASH
- Medical subject headings
- Hypertension, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Lifestyle ModificationBehavioural
- 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 DASHBehavioural
- Modified DASH (vegetarian focused, plant-based, low-salt)
- Aerobic exercise
- Stress reduction techniques: progressive muscle relaxation
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Lifestyle Modification | Experimental | Not described Receives: Behavioral: Comprehensive Lifestyle Modification |
| Standard Lifestyle Modification / modified DASH | Active comparator | Not described Receives: Behavioral: Standard Lifestyle Modification / modified DASH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
24-hour ambulatory blood pressure
Measured: 3 months
HOMA Index
Homeostatic Model Assessment
Measured: 3 months
Secondary outcomes (37)
Blood pressure
24-hour ambulatory blood pressure
Measured: 3 months, 6 months, 12 months
Blood pressure
Sphygmomanometer
Measured: 1 week, 3 months, 6 months, 12 months
Pulse wave velocity
Pulse wave velocity (PWV) is a measure of arterial stiffness
Measured: 3 months, 6 months, 12 months
PROCAM
PROCAM risk score
Measured: 1 week, 3 months, 6 months, 12 months
SCORE
SCORE risk score
Measured: 1 week, 3 months, 6 months, 12 months
Waist circumference
Measured: 1 week, 3 months, 6 months, 12 months
Weight
Measured: 1 week, 3 months, 6 months, 12 months
Blood glucose level
Measured: 1 week, 3 months, 6 months, 12 months
Blood insulin level
Measured: 1 week, 3 months, 6 months, 12 months
HbA1C
Longterm parameter for plasma glucose concentration.
Measured: 3 months, 6 months, 12 months
Blood creatinine level
Measured: 1 week, 3 months, 6 months, 12 months
Total cholesterol
Measured: 1 week, 3 months, 6 months, 12 months
LDL cholesterol
Measured: 1 week, 3 months, 6 months, 12 months
HDL cholesterol
Measured: 1 week, 3 months, 6 months, 12 months
Medication use
Measured: 1 week, 3 months, 6 months, 12 months
HADS
Hospital Anxiety and Depression Scale
Measured: 1 week, 3 months, 6 months, 12 months
POMS
Profile of Mood States
Measured: 1 week, 3 months, 6 months, 12 months
CPSS
Cohen Perceived Stress Scale
Measured: 3 months, 6 months, 12 months
SWE
General self-efficacy (Skala zur Allgemeinen Selbstwirksamkeitserwartung)
Measured: 1 week, 3 months, 6 months, 12 months
SF-36
Health-related quality of life
Measured: 3 months, 6 months, 12 months
MAAS
Mindfulness Attention Awareness Scale
Measured: 3 months, 6 months, 12 months
SCS
Self-Compassion Scale
Measured: 1 week, 3 months, 6 months, 12 months
Lifestyle questionnaire
Questionnaire on physical activity, stress management, diet
Measured: 3 months, 6 months, 12 months
Hair steroid analysis
Assessment of long-term glucocorticoid levels in scalp hair.
Measured: 6 months, 12 months
Bioelectrical impedance analysis
Method for estimating body composition (body fat).
Measured: 1 week, 3 months, 6 months, 12 months
Waist/hip ratio
Measured: 1 week, 3 months, 6 months, 12 months
Immunophenotyping
Assessment of immunological subsets in PBMCs
Measured: 1 week, 3 months, 6 months
Intestinal microbiota
Characterization of gut microbiota.
Measured: 1 week, 3 months, 6 months
Metabolomics
Assessment of small-molecule metabolite profiles from capillary blood
Measured: 1 week, 3 months
Gene expression profiling
Assessment of gene expression profiles from PBMCs.
Measured: 1 week, 3 months
Interleukin- 6
Measured: 1 week, 3 months, 6 months, 12 months
CRP
Measured: 1 week, 3 months, 6 months, 12 months
Uric acid
Measured: 1 week, 3 months, 6 months, 12 months
Insulin-like growth factor (IGF-1)
Measured: 1 week, 3 months, 6 months, 12 months
Adverse events
Adverse events
Measured: 1 week, 3 months, 6 months, 12 months
Framingham-Score
Measured: 1 week, 3 months, 6 months, 12 months
JBS3-Score
Measured: 1 week, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Kliniken Essen-Mitte, Immanuel Hospital, Berlin, Germany, Charite University, Berlin, Germany, University of Witten/Herdecke
- Responsible party
- Principal investigator, Gustav Dobos, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099968
- Sponsor's protocol ID
- CORONA
- Status last verified
- Jul 2019
- First submitted
- 26 Mar 2014
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33785752
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensivierte Ernährungs- Und Lebensstilmodifikation Bei Patienten Mit Bluthochdruck Und Kardiometabolischer Risikokonstellation. Eine Zweizentrische Randomisiert-kontrollierte Interventionsstudie über 6 Monate
- ClinicalTrials.gov ID
- NCT02099968
- Acronym / sponsor ID
- CORONA
- Conditions
- Hypertension, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Kliniken Essen-Mitte, Immanuel Hospital, Berlin, Germany, Charite University, Berlin, Germany, University of Witten/Herdecke
- Study start
- Apr 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Lifestyle Modification | Experimental | Behavioral: Comprehensive Lifestyle Modification |
| Standard Lifestyle Modification / modified DASH | Active comparator | Behavioral: Standard Lifestyle Modification / modified DASH |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertension or antihypertensive medication or subclinical atherosclerosis
- Metabolic syndrome
- Basic mobility
Key exclusion criteria (10 listed)
- Diabetes type 1
- Insulin bolus therapy
- Coronary artery disease
- Myocardial infarct, pulmonary embolism, or stroke within the past 3 months
- Heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Comprehensive Lifestyle Modification |
| Standard Lifestyle Modification / modified DASH* Modified DASH (vegetarian focused, plant-based, low-salt) * Aerobic exercise * Stress reduction techniques: progressive muscle relaxation | Behavioural | Standard Lifestyle Modification / modified DASH |
Primary outcome
Systolic blood pressure
Time frame: 3 months
24-hour ambulatory blood pressure
HOMA Index
Time frame: 3 months
Homeostatic Model Assessment
37 secondary outcomes
Blood pressure
Time frame: 3 months, 6 months, 12 months
Blood pressure
Time frame: 1 week, 3 months, 6 months, 12 months
Pulse wave velocity
Time frame: 3 months, 6 months, 12 months
PROCAM
Time frame: 1 week, 3 months, 6 months, 12 months
SCORE
Time frame: 1 week, 3 months, 6 months, 12 months
Waist circumference
Time frame: 1 week, 3 months, 6 months, 12 months
Weight
Time frame: 1 week, 3 months, 6 months, 12 months
Blood glucose level
Time frame: 1 week, 3 months, 6 months, 12 months
Blood insulin level
Time frame: 1 week, 3 months, 6 months, 12 months
HbA1C
Time frame: 3 months, 6 months, 12 months
Blood creatinine level
Time frame: 1 week, 3 months, 6 months, 12 months
Total cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
LDL cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
HDL cholesterol
Time frame: 1 week, 3 months, 6 months, 12 months
Medication use
Time frame: 1 week, 3 months, 6 months, 12 months
HADS
Time frame: 1 week, 3 months, 6 months, 12 months
POMS
Time frame: 1 week, 3 months, 6 months, 12 months
CPSS
Time frame: 3 months, 6 months, 12 months
SWE
Time frame: 1 week, 3 months, 6 months, 12 months
SF-36
Time frame: 3 months, 6 months, 12 months
MAAS
Time frame: 3 months, 6 months, 12 months
SCS
Time frame: 1 week, 3 months, 6 months, 12 months
Lifestyle questionnaire
Time frame: 3 months, 6 months, 12 months
Hair steroid analysis
Time frame: 6 months, 12 months
Bioelectrical impedance analysis
Time frame: 1 week, 3 months, 6 months, 12 months
Waist/hip ratio
Time frame: 1 week, 3 months, 6 months, 12 months
Immunophenotyping
Time frame: 1 week, 3 months, 6 months
Intestinal microbiota
Time frame: 1 week, 3 months, 6 months
Metabolomics
Time frame: 1 week, 3 months
Gene expression profiling
Time frame: 1 week, 3 months
Interleukin- 6
Time frame: 1 week, 3 months, 6 months, 12 months
CRP
Time frame: 1 week, 3 months, 6 months, 12 months
Uric acid
Time frame: 1 week, 3 months, 6 months, 12 months
Insulin-like growth factor (IGF-1)
Time frame: 1 week, 3 months, 6 months, 12 months
Adverse events
Time frame: 1 week, 3 months, 6 months, 12 months
Framingham-Score
Time frame: 1 week, 3 months, 6 months, 12 months
JBS3-Score
Time frame: 1 week, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Derived from this study: PubMed 33785752Maifeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Lifestyle Modification and Standard Lifestyle Modification / modified DASH in people with Hypertension and Metabolic Syndrome, run by Universität Duisburg-Essen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02099968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.