HypertensionNCT05669404
Effects of the DASH vs. the Mediterranean Diet Combined With Salt Restriction on Blood Pressure Levels in Adults
A study testing Salt Restriction Group (SRG), DASH Diet combined with salt restriction Group (DDG) and Mediterranean Diet combined with salt restriction Group (MDG) in people with Hypertension, run by Hippocration General Hospital at 1 site in Greece.
Trial summary
Non-pharmacological measures should serve as the first-line treatment in individuals with high normal blood pressure (BP) levels or grade 1 hypertension and low-moderate cardiovascular disease risk. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Salt Restriction Group (SRG), DASH Diet combined with salt restriction Group (DDG) and Mediterranean Diet combined with salt restriction Group (MDG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteGreece
- Study dates
- 7 Jan 2019to 9 Sep 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg) and low-moderate 10-year cardiovascular disease risk.
- Willingness to participate in a dietary intervention to control BP and to attend individual sessions.
- Signed informed consent form for participation.
Who cannot join
- Current use of anti-hypertensive medications.
- Current use of any other medications or agents affecting BP levels (e.g., nonsteroidal anti-inflammatory drugs).
- Use of food supplements accompanied by a refusal to discontinue them.
- Participation in a clinical study involving a drug or device within 3 months of screening.
- Active weight loss or participation in a weight loss treatment program within 3 months of screening.
- Secondary hypertension.
Show all 19Show fewer
- Atomic history of cardiovascular disease (e.g. acute myocardial infarction, stroke, heart failure).
- Diabetes Mellitus (Type 1 \& 2).
- Chronic kidney disease, defined as an estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2.
- Liver disease (e.g., hepatitis, cirrhosis).
- Lung disease (e.g., chronic obstructive pulmonary disease).
- Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
- Celiac disease.
- Active malignancy or cancer therapy.
- Current major psychiatric disorder or current drug abuse.
- Body Mass Index >40 kg/m2.
- Current alcohol consumption >14 drinks per week.
- Current or planned pregnancy before the end of the study, or breast-feeding.
- Any concomitant conditions that in the opinion of the investigator interfere with the diet or other situations requiring specific nutritional management.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hypertension Unit, First Cardiology Clinic, Hippocration General Hospital, National and Kapodistrian University of Athens
Athens, 11527
About this study
Official title: Effects of the DASH and the Mediterranean Diet Combined With Salt Restriction on Blood Pressure Levels and Cardiometabolic Risk Factors in Adults With High Normal Blood Pressure or Grade 1 Hypertension: A Randomized Controlled Trial
Non-pharmacological measures should serve as the first-line treatment in individuals with high normal blood pressure (BP) levels or grade 1 hypertension and low-moderate cardiovascular disease risk. Salt intake reduction and the dietary patterns of the Dietary Approaches to Stop Hypertension (DASH) diet and the Mediterranean diet (MedDiet) have been recognized as effective dietary measures for BP reduction. To the best of our knowledge, no clinical trials were designed to compare the effects of these dietary strategies. The purpose of the present trial was to compare the effects of salt restriction, the DASH, and the MedDiet combined with the salt restriction on BP levels and cardiometabolic risk factors in adults with high normal BP or grade 1 hypertension over 3 months.
Read the detailed description
This was a 3-month, single-center, single-blind, randomized, controlled, clinical trial, with 4 parallel groups. Before their randomization, the potential participants visiting the Hypertension Unit of the Hippocration General Hospital of Athens for the first time were assessed for eligibility during two screen visits. Anthropometric measurements, demographic characteristics, dietary intake, physical activity level, smoking history, and alcohol consumption were recorded. In addition, office and ambulatory BP measurements, as well as fasting blood samples and 24-hour urine samples were obtained. Patients were eligible for inclusion if they had high normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg), based on the average of the means of the last two out of three measurements made during the two screen visits and were free of antihypertensive drug treatment and major medical conditions. Enrolled patients were blindly randomized to one of the four study groups, i.e., control group (CG), salt restriction group (SRG), DASH diet combined with salt restriction group (DDG), or MedDiet combined with salt restriction group (MDG). After randomization, all patients were followed monthly for 3 months in individual sessions, coordinated by the clinical dietician. For the patients of all four study groups, the goal was to maintain the initial body weight stable. Patients in the CG received the usual advice about salt restriction given to the patients by the clinical dietician at the Hypertension Unit. They were followed at the same frequency as the patients in the other study groups to obtain the study's intended measurements, without any other intervention. For the patients in the three intervention groups, the goal was to limit sodium intake to 2,000 mg/ day. Patients in the SRG were given a detailed booklet containing information about table salt and during each 45-min individual session, they received intensive counselling and training to increase adherence to salt restriction. Patients in the DDG and the MDG received a more extensive booklet, which also contained information about the assigned dietary pattern and an individualized eating plan, while during the 45-min individual sessions, patients in these two intervention groups were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Adherence to the assigned diet and/or salt restriction was established through subjective and objective measures, i.e., 7-day food records, adherence scores, and 24-hour urine tests. Anthropometric indices, dietary intake, physical activity level, and office BP were measured at baseline, and during each follow-up visit. Ambulatory BP measurements and collection of fasting blood samples and 24-hour urine samples were conducted at baseline and the end of the 3-month intervention.
- Conditions
- Hypertension
- Being tested
- Salt Restriction Group (SRG), DASH Diet combined with salt restriction Group (DDG), Mediterranean Diet combined with salt restriction Group (MDG)
- Keywords
- Hypertension, Blood pressure, Diet, Salt, Dietary Approaches to Stop Hypertension, Mediterranean, Dietary pattern
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt Restriction Group (SRG)Behavioural
Patients assigned to the SRG continued to consume their usual diet, but they had to restrict their sodium intake to 2,000 mg/ day. They were given a detailed booklet containing information about table salt, foods rich in sodium, and practical ways to decrease salt consumption. During each 45-min individual session, they received intensive counselling and training to increase adherence to salt restriction. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.
DASH Diet combined with salt restriction Group (DDG)Behavioural
Patients assigned to the DDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the DASH diet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the DASH diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.
Mediterranean Diet combined with salt restriction Group (MDG)Behavioural
Patients assigned to the MDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the MedDiet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the MedDiet diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (CG) | No intervention | Patients continued to consume their usual diet for 3 months |
| Salt Restriction Group (SRG) | Experimental | Patients continued to consume their usual diet, but they restricted sodium intake to 2,000 mg/ day for 3 months. Receives: Behavioral: Salt Restriction Group (SRG) |
| DASH Diet combined with salt restriction Group (DDG) | Experimental | Patients consumed the DASH diet for 3 months. Receives: Behavioral: DASH Diet combined with salt restriction Group (DDG) |
| Mediterranean Diet combined with salt restriction Group (MDG) | Experimental | Patients consumed the MedDiet diet for 3 months. Receives: Behavioral: Mediterranean Diet combined with salt restriction Group (MDG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Office systolic blood pressure (BP)
The attained mean office systolic BP difference among the randomized arms
Measured: 3 months post-intervention
Secondary outcomes (4)
Office diastolic blood pressure (BP)
The attained mean office diastolic BP difference among the randomized arms
Measured: 3 months post-intervention
Ambulatory systolic and diastolic blood pressure (BP)
The attained between-group differences regarding the mean ambulatory BP measurements (during 24h, daytime, and night-time)
Measured: 3 months post-intervention
Odds of hypertension
The odds of hypertension according to the office BP measurements in each study group
Measured: 3 months post-intervention
Metabolic syndrome and its components
The attained between-group differences in metabolic syndrome presence and in the presence of individual metabolic syndrome components
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start7 Jan 2019
- Primary completion27 May 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients were blindly randomized with a 1:1:1:1 allocation to one of the four study groups, i.e., control group (CG), salt restriction group (SRG), DASH diet combined with salt restriction group (DDG), or MedDiet combined with salt restriction group (MDG).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocration General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Tsioufis, Hippocration General Hospital
- Investigators
- Konstantinos P Tsioufis, Prof., Principal investigator, First Cardiology Clinic, Hippocration General Hospital, NKUA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669404
- Sponsor's protocol ID
- The DASH-MedDiet study
- Status last verified
- Sep 2023
- First submitted
- 14 Dec 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the DASH and the Mediterranean Diet Combined With Salt Restriction on Blood Pressure Levels and Cardiometabolic Risk Factors in Adults With High Normal Blood Pressure or Grade 1 Hypertension: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05669404
- Acronym / sponsor ID
- The DASH-MedDiet study
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure, Diet, Salt, Dietary Approaches to Stop Hypertension, Mediterranean, Dietary pattern
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hippocration General HospitalUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 30 Dec 2022 (actual)
- 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.
Non-pharmacological measures should serve as the first-line treatment in individuals with high normal blood pressure (BP) levels or grade 1 hypertension and low-moderate cardiovascular disease risk. Salt intake reduction and the dietary patterns of the Dietary Approaches to Stop Hypertension (DASH) diet and the Mediterranean diet (MedDiet) have been recognized as effective dietary measures for BP reduction. To the best of our knowledge, no clinical trials were designed to compare the effects of these dietary strategies. The purpose of the present trial was to compare the effects of salt restriction, the DASH, and the MedDiet combined with the salt restriction on BP levels and cardiometabolic risk factors in adults with high normal BP or grade 1 hypertension over 3 months.
Detailed description
This was a 3-month, single-center, single-blind, randomized, controlled, clinical trial, with 4 parallel groups. Before their randomization, the potential participants visiting the Hypertension Unit of the Hippocration General Hospital of Athens for the first time were assessed for eligibility during two screen visits. Anthropometric measurements, demographic characteristics, dietary intake, physical activity level, smoking history, and alcohol consumption were recorded. In addition, office and ambulatory BP measurements, as well as fasting blood samples and 24-hour urine samples were obtained. Patients were eligible for inclusion if they had high normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg), based on the average of the means of the last two out of three measurements made during the two screen visits and were free of antihypertensive drug treatment and major medical conditions. Enrolled patients were blindly randomized to one of the four study groups, i.e., control group (CG), salt restriction group (SRG), DASH diet combined with salt restriction group (DDG), or MedDiet combined with salt restriction group (MDG). After randomization, all patients were followed monthly for 3 months in individual sessions, coordinated by the clinical dietician. For the patients of all four study groups, the goal was to maintain the initial body weight stable. Patients in the CG received the usual advice about salt restriction given to the patients by the clinical dietician at the Hypertension Unit. They were followed at the same frequency as the patients in the other study groups to obtain the study's intended measurements, without any other intervention. For the patients in the three intervention groups, the goal was to limit sodium intake to 2,000 mg/ day. Patients in the SRG were given a detailed booklet containing information about table salt and during each 45-min individual session, they received intensive counselling and training to increase adherence to salt restriction. Patients in the DDG and the MDG received a more extensive booklet, which also contained information about the assigned dietary pattern and an individualized eating plan, while during the 45-min individual sessions, patients in these two intervention groups were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Adherence to the assigned diet and/or salt restriction was established through subjective and objective measures, i.e., 7-day food records, adherence scores, and 24-hour urine tests. Anthropometric indices, dietary intake, physical activity level, and office BP were measured at baseline, and during each follow-up visit. Ambulatory BP measurements and collection of fasting blood samples and 24-hour urine samples were conducted at baseline and the end of the 3-month intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Enrolled patients were blindly randomized with a 1:1:1:1 allocation to one of the four study groups, i.e., control group (CG), salt restriction group (SRG), DASH diet combined with salt restriction group (DDG), or MedDiet combined with salt restriction group (MDG).
| Arm | Type | Receives |
|---|---|---|
| Control Group (CG) | No intervention | –Patients continued to consume their usual diet for 3 months |
| Salt Restriction Group (SRG) | Experimental | Behavioral: Salt Restriction Group (SRG)Patients continued to consume their usual diet, but they restricted sodium intake to 2,000 mg/ day for 3 months. |
| DASH Diet combined with salt restriction Group (DDG) | Experimental | Behavioral: DASH Diet combined with salt restriction Group (DDG)Patients consumed the DASH diet for 3 months. |
| Mediterranean Diet combined with salt restriction Group (MDG) | Experimental | Behavioral: Mediterranean Diet combined with salt restriction Group (MDG)Patients consumed the MedDiet diet for 3 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- High normal BP (office systolic BP: 130-139 mmHg and/or office diastolic BP: 85-89 mmHg) or grade 1 hypertension (office systolic BP: 140-159 mmHg and/or office diastolic BP: 90-99 mmHg) and low-moderate 10-year cardiovascular disease risk.
- Willingness to participate in a dietary intervention to control BP and to attend individual sessions.
- Signed informed consent form for participation.
Key exclusion criteria (19 listed)
- Current use of anti-hypertensive medications.
- Current use of any other medications or agents affecting BP levels (e.g., nonsteroidal anti-inflammatory drugs).
- Use of food supplements accompanied by a refusal to discontinue them.
- Participation in a clinical study involving a drug or device within 3 months of screening.
- Active weight loss or participation in a weight loss treatment program within 3 months of screening.
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 |
|---|---|---|
| Salt Restriction Group (SRG)Patients assigned to the SRG continued to consume their usual diet, but they had to restrict their sodium intake to 2,000 mg/ day. They were given a detailed booklet containing information about table salt, foods rich in sodium, and practical ways to decrease salt consumption. During each 45-min individual session, they received intensive counselling and training to increase adherence to salt restriction. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months. | Behavioural | Salt Restriction Group (SRG) |
| DASH Diet combined with salt restriction Group (DDG)Patients assigned to the DDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the DASH diet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the DASH diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months. | Behavioural | DASH Diet combined with salt restriction Group (DDG) |
| Mediterranean Diet combined with salt restriction Group (MDG)Patients assigned to the MDG received a more extensive booklet, which which in addition to the information regarding salt restriction, contained detailed information about the MedDiet, and practical advice about how to start and stay on the assigned dietary pattern. In addition to the booklet, each patient received an individualized eating plan with six sample daily menus, incorporating the goals of the MedDiet diet. During the 45-min individual sessions, patients were intensively counselled and trained to increase adherence to salt restriction and the assigned dietary pattern. Also, they were instructed to keep their body weight stable and not to change their physical activity level over the next 3 months. | Behavioural | Mediterranean Diet combined with salt restriction Group (MDG) |
Primary outcome
Office systolic blood pressure (BP)
Time frame: 3 months post-intervention
The attained mean office systolic BP difference among the randomized arms
4 secondary outcomes
Office diastolic blood pressure (BP)
Time frame: 3 months post-intervention
Ambulatory systolic and diastolic blood pressure (BP)
Time frame: 3 months post-intervention
Odds of hypertension
Time frame: 3 months post-intervention
Metabolic syndrome and its components
Time frame: 3 months post-intervention
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 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Konstantinos P Tsioufis, Prof. principal investigator
First Cardiology Clinic, Hippocration General Hospital, NKUA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt Restriction Group (SRG), DASH Diet combined with salt restriction Group (DDG) and Mediterranean Diet combined with salt restriction Group (MDG) in people with Hypertension, run by Hippocration General Hospital at 1 site in Greece.
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 19 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Office systolic blood pressure (BP) (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2023.