Arterial HypertensionNCT06457711

Blood Pressure and Cardiometabolic Risk (Diet-to-HTN)

A study testing Free diet Group (FDG), Very low Calorie Ketogenic Diet Group (VLCKDG) and Intermittent Fasting Group (IFG) in people with Arterial Hypertension and Menopause, run by University of Roma La Sapienza at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Arterial Hypertension, Menopause, Obesity
What is being tested?: Free diet Group (FDG), Very low Calorie Ketogenic Diet Group (VLCKDG) and Intermittent Fasting Group (IFG)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteItaly
Study dates: 22 Jun 2022to 22 Jun 2023
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 50 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

female individuals,
aged between 50 and 65 years,
BMI ≥25 kg/m2;
diagnosis of essential uncomplicated arterial hypertension for at least 6 months;
perimenopause or menopause confirmed,
provision of informed consent.

Who cannot join

previous history of major CVDs;
severe heart or renal failure;
poor adherence to prescribed pharmacological and non-pharmacological treatments;
treated uncontrolled hypertension or diabetes;
secondary forms of hypertension;
uncontrolled thyroid diseases;

Show all 12Show fewer

previous bariatric surgery or endoscopic bariatric procedures;
regular engagement in competitive sports activities;
history of alcoholism and/or drug addiction;
psychiatric and/or neurological conditions affecting the understanding and giving of informed consent;
cancer or any other progressive severe disease;
use of pharmacological treatments known to may interfere with the main purposes of the study protocol.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Sapienza University of Rome
Rome, RM, 00189

Other trials in Italy

About this study

Official title: Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)

Obesity is a significant health issue that increases the risk of serious cardiovascular problems. In recent years, two dietary methods, the Ketogenic Diet (KD) and Intermittent Fasting (IF), have become popular for their potential to treat obesity and its related issue, hypertension. While both diets are known for their effectiveness in weight loss, their specific impacts on blood pressure (BP) and overall heart health risks are less understood especially in menopausal women.

The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular, unrestricted diet (referred to as Free Diet or FD) in terms of their effects on clinic blood pressure levels in menopausal women.

Additionally, the study looked at changes in Body Mass Index (BMI), the percentage of total body weight loss, body fat percentage, waist and hip measurements, the ratio of waist-to-hip size, and the Phase Angle (PhA), which is a measure of the body's overall health status.

Read the detailed description

This research was conducted as a single-center, prospective, open-label clinical trial at Sant'Andrea Hospital in Rome, Italy. Participants included menopausal women with a BMI of 25 kg/m² or higher, who were already being treated for uncomplicated hypertension. These women were assessed at the hospital's Hypertension Unit and then placed into one of three diet groups: Ketogenic Diet, Intermittent Fasting, or Free Diet. Each participant received personalized dietary advice, underwent regular blood pressure checks aligned with European health guidelines, and completed standard health tests including electrocardiograms and blood tests for glucose, lipids, and liver and kidney functions. Measurements of all key health indicators were taken at the start of the study, then again after two months and six months.

This study is designed to offer clearer insights into how specific dietary choices can affect cardiovascular health and help manage hypertension in obese individuals.

Conditions: Arterial Hypertension, Menopause, Obesity, Cardiometabolic Syndrome, Cardiovascular Diseases
Being tested: Free diet Group (FDG), Very low Calorie Ketogenic Diet Group (VLCKDG), Intermittent Fasting Group (IFG)
Keywords: blood pressure, diet, menopause, women, cardiometabolic risk
Medical subject headings: Hypertension, Obesity, Metabolic Syndrome, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Free diet Group (FDG)Dietary supplement
Participants were offered nutritional guidance and were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate.
Very low Calorie Ketogenic Diet Group (VLCKDG)Dietary supplement
Participants were offered nutritional guidance and were encouraged to adhere to the principles of the very low-calorie ketogenic diet (VLCKD) protocol
Intermittent Fasting Group (IFG)Dietary supplement
Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule

Study groups in NCT06457711
Study group	Role	What they receive
Free diet Group (FDG)	Other	participants were offered nutritional guidance without strict limitations, but were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate. Receives: Dietary Supplement: Free diet Group (FDG)
Very low Calorie Ketogenic Diet Group (VLCKDG)	Experimental	the very low-calorie ketogenic diet (VLCKD) protocol involved limited carbohydrate consumption to less than 30 grams per day. The protocol suggested a protein intake ranging from 1 to 1.5 grams per kilogram of ideal body weight, with fats limited to 15-30 grams per day and total daily calories estimated between 600 and 800 kcal. During the initial three-week phase of the diet, participants replaced two meals per day with meal replacements-specifically, breakfast and one other main meal were substituted with a protein shake. Accompanying the shake for the main meal were low-glycemic-index vegetables in prescribed quantities. Receives: Dietary Supplement: Very low Calorie Ketogenic Diet Group (VLCKDG)
Intermittent Fasting Group (IFG)	Active comparator	Our participant followed an intermittent fasting schedule, specifically the 16/8 method, which involves eating only during an eight-hour window each day and fasting for the subsequent sixteen hours. This eating period began at 12:00 noon and ended at 8:00 PM. During this window, the patient consumed three meals, each with a caloric value reduced by 25% from their total daily energy expenditure. The meals were based on the Mediterranean diet, focusing on the balance and quality of macronutrients. Receives: Dietary Supplement: Intermittent Fasting Group (IFG)

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinic systolic brachial BP levels.
The primary aim was to evaluate the effects of Very low calorie Ketogenic Diet or intermittent fasting compared to Free Diet on clinic systolic brachial BP levels (mmHg).
Measured: 6 months

Secondary outcomes (5)

Body composition: BMI
Secondary outcomes included changes from baseline of Body Mass Index (BMI) weight and height will be combined to report BMI in kg/m^2.
Measured: 6 months
Body composition: Fat mass (%)
Secondary outcomes included changes from baseline of Percentage of total body weight loss (TWL %), Body Fat Percentage (BFP %) derived from Bioelectrical impedance analysis (BIA)
Measured: 6 months
Body composition: circumference
Secondary outcomes included changes from baseline of waist (WC) and hip circumference (cm), combined in waist-hip ratio (WHR)
Measured: 6 months
Body Composition: Bioelectrical impedance analysis (BIA)
Secondary outcomes included changes from baseline of Phase Angle °
Measured: 6 months
Clinic diastolic brachial BP levels.
Secondary outcomes included modulation of diastolic blood pressure
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jun 202222 Jun 2023

First posted13 Jun 2024
Study start22 Jun 2022
Primary completion22 Jun 2023
Study completion22 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Arterial HypertensionStudies of the same condition, open and under way.
More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Model description: The investigators enrolled 50 patient to divide in 20 patients in the KD group, 20 in the IF group and 10 in the FD. Seven patients dropped out from their assigned groups as follows: FD (n = 2), IF (n = 3), and KD (n = 2).
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06457711
Sponsor's protocol ID: NCTBPCMR
Status last verified: Jul 2024
First submitted: 1 Jun 2024
Last updated: 16 Jul 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Blood Pressure and Cardiometabolic Risk in Postmenopausal Women With Hypertension and Obesity: A Real-World Study (Diet-to-HTN)
ClinicalTrials.gov ID: NCT06457711
Acronym / sponsor ID: NCTBPCMR
Conditions: Arterial Hypertension, Menopause, Obesity, Cardiometabolic Syndrome, Cardiovascular Diseases
Keywords: blood pressure, diet, menopause, women, cardiometabolic risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of Roma La SapienzaUniversity, hospital or other
Study start: 22 Jun 2022 (actual)
Primary completion: 22 Jun 2023 (actual)
Study completion: 22 Jun 2023 (actual)
First posted: 13 Jun 2024 (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.

Detailed description

This study is designed to offer clearer insights into how specific dietary choices can affect cardiovascular health and help manage hypertension in obese individuals.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The investigators enrolled 50 patient to divide in 20 patients in the KD group, 20 in the IF group and 10 in the FD. Seven patients dropped out from their assigned groups as follows: FD (n = 2), IF (n = 3), and KD (n = 2).

Arm	Type	Receives
Free diet Group (FDG)	Other	Dietary Supplement: Free diet Group (FDG)participants were offered nutritional guidance without strict limitations, but were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate.
Very low Calorie Ketogenic Diet Group (VLCKDG)	Experimental	Dietary Supplement: Very low Calorie Ketogenic Diet Group (VLCKDG)the very low-calorie ketogenic diet (VLCKD) protocol involved limited carbohydrate consumption to less than 30 grams per day. The protocol suggested a protein intake ranging from 1 to 1.5 grams per kilogram of ideal body weight, with fats limited to 15-30 grams per day and total daily calories estimated between 600 and 800 kcal. During the initial three-week phase of the diet, participants replaced two meals per day with meal replacements-specifically, breakfast and one other main meal were substituted with a protein shake. Accompanying the shake for the main meal were low-glycemic-index vegetables in prescribed quantities.
Intermittent Fasting Group (IFG)	Active comparator	Dietary Supplement: Intermittent Fasting Group (IFG)Our participant followed an intermittent fasting schedule, specifically the 16/8 method, which involves eating only during an eight-hour window each day and fasting for the subsequent sixteen hours. This eating period began at 12:00 noon and ended at 8:00 PM. During this window, the patient consumed three meals, each with a caloric value reduced by 25% from their total daily energy expenditure. The meals were based on the Mediterranean diet, focusing on the balance and quality of macronutrients.

Who may qualify

Ages: 50 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

female individuals,
aged between 50 and 65 years,
BMI ≥25 kg/m2;
diagnosis of essential uncomplicated arterial hypertension for at least 6 months;
perimenopause or menopause confirmed,

Key exclusion criteria (12 listed)

previous history of major CVDs;
severe heart or renal failure;
poor adherence to prescribed pharmacological and non-pharmacological treatments;
treated uncontrolled hypertension or diabetes;
secondary forms of hypertension;

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
Free diet Group (FDG)Participants were offered nutritional guidance and were encouraged to adhere to the principles of the Mediterranean diet and follow the dietary recommendations outlined in Harvard's Healthy Eating Plate.	Dietary supplement	Free diet Group (FDG)
Very low Calorie Ketogenic Diet Group (VLCKDG)Participants were offered nutritional guidance and were encouraged to adhere to the principles of the very low-calorie ketogenic diet (VLCKD) protocol	Dietary supplement	Very low Calorie Ketogenic Diet Group (VLCKDG)
Intermittent Fasting Group (IFG)Participants were offered nutritional guidance and were encouraged to adhere to the principles of the intermittent fasting schedule	Dietary supplement	Intermittent Fasting Group (IFG)

Primary outcome

Clinic systolic brachial BP levels.
Time frame: 6 months
The primary aim was to evaluate the effects of Very low calorie Ketogenic Diet or intermittent fasting compared to Free Diet on clinic systolic brachial BP levels (mmHg).

5 secondary outcomes

Body composition: BMI
Time frame: 6 months
Body composition: Fat mass (%)
Time frame: 6 months
Body composition: circumference
Time frame: 6 months
Body Composition: Bioelectrical impedance analysis (BIA)
Time frame: 6 months
Clinic diastolic brachial BP levels.
Time frame: 6 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 16 Jul 2024.
Individual participant dataSharing planned: Undecided

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 12 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 16 Jul 2024. 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 Italy. 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?

Clinic systolic brachial BP levels. (time frame: 6 months). 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 NCT06457711.

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 16 Jul 2024.