NutritionNCT06978504
Impact of Genetic Polymorphisms And DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome
A study testing DASH diet in people with Nutrition and Metabolic Syndrome, run by Nutrindo Ideais Research Center at 1 site in Brazil.
Trial summary
Metabolic syndrome is a multifactorial inflammatory condition that is very prevalent in overweight women with type 2 diabetes. However, there seems to be great benefit in changing lifestyle and dietary patterns in the treatment of this condition. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Metabolic Syndrome, Obesity
- What is being tested?
- DASH diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2025to 3 Aug 2026
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study population will consist of menopausal women aged between 40 to 60 years old
- Obese (BMI > 30) with a diagnosis of MS.
- The inclusion criteria are the presence of at least 3 of the 5 criteria for MS, which include:
- Abnormal waist circumference values (≥89 cm in women)
- SBP ≥120 mm Hg and DBP ≥80 mm Hg) or diagnosis of hypertension
- Fasting blood glucose equal to or greater than 100 mg/dL or diagnosis of DM2
- HDL-c less than 50 mg/dL in women
- Triglycerides ≥150 mg/dL.
Who cannot join
- Patients with a BMI <25 kg/m2
- The following chronic diseases will not be eligible:
- Active cancer
- Active tuberculosis
- Psychiatric illnesses
- Multiple sclerosis
Show all 9Show fewer
- Severe nephropathy
- Advanced stages of Paget's disease.
- These chronic conditions could interfere with the results of this study, especially adherence to diet and weight loss. Patients who do not complete all stages of the study, who are not adhering to the intervention or who present any complication that interferes with the results of the study will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Nutrindo Ideais Research Center
Rio de Janeiro, Rio de Janeiro, 22421-000
About this study
Official title: What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?
Metabolic syndrome is a multifactorial inflammatory condition that is very prevalent in overweight women with type 2 diabetes. However, there seems to be great benefit in changing lifestyle and dietary patterns in the treatment of this condition. Currently, few studies have shown the effect of a Dietary Approach to Stop Hypertension (DASH) diet in postmenopausal women with metabolic syndrome and the influence of genetic polymorphisms of the fat mass and obesity-associated protein (FTO) and beta-2 adrenergic receptor (ADRB2) genes on inflammatory markers and improvement of laboratory indicators in these patients. This study aims to analyze the interaction of polymorphisms in the ADRB2 and FTO genes and the DASH diet on anthropometric indicators and laboratory tests in patients with metabolic syndrome in the city of Rio de Janeiro. For this purpose, laboratory tests and anthropometric data will be collected in a prospective study with women aged between 40 and 60 years.
Read the detailed description
Prospective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90, and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that the nutritionist will apply. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90.
Only one nutritionist will make the dietary prescription to maintain the standardization of the research. The diets will be previously calculated, varying from 100 to 100 kcal (1400 to 2600 kcal) based on the patients' total energy value (TEV). The isocaloric, balanced, and individualized diet will be calculated according to the resting metabolic rate (RMR) obtained by the prediction equation and multiplied by the corresponding activity factor to obtain the TEV. The DASH eating plan will consist of fruits, vegetables, legumes, whole grains, and low-fat dairy products. White meat will be prioritized over red meat, seeds and oilseeds will be included, and sweets and foods rich in sodium will be limited.
Dietary assessment will be performed using periodic dietary record forms (24-hour records) for three non-consecutive days, two typical days, and one atypical day, to analyze the participants' eating habits before the dietary intervention. The participants will complete periodic records at seven points before the intervention begins at t15, t30, t45, t60, t75, and at the end of the 90-day study. The nutritionist will review all forms to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation) and notes that could raise questions later (few items recorded, unknown foods, errors in household measurements, and absence of any meal).
- Conditions
- Nutrition, Metabolic Syndrome, Obesity, Weight Loss, Genetic Polymorphisms
- Being tested
- DASH diet
- Keywords
- Dash, Nutrition, Weight Loss, metabolic Syndrome, genetic polymorphisms
- Medical subject headings
- Metabolic Syndrome, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DASH dietOther
Prospective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90 and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that will be applied by the nutritionist. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 30 menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have in-person and online consultations with a nutritionist every 15 days for 3 months to assess their previous habitual food intake and their nutritional adherence to DASH Diet. Receives: Other: DASH diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and Diastolic blood pressure in mmHg
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Measured: Baseline
Systolic and Diastolic blood pressure in mmHg
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Measured: 30 days
Systolic and Diastolic blood pressure in mmHg
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Measured: 60 days
Systolic and Diastolic blood pressure in mmHg
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Measured: 90 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Measured: Baseline
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Measured: 30 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Measured: 60 days
Body composition and body fat percentage
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Measured: 90 days
Periodic dietary record forms (24h record)
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Measured: Baseline
Periodic dietary record forms (24h record)
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Measured: 30 days
Periodic dietary record forms (24h record)
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Measured: 60 days
Periodic dietary record forms (24h record)
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Measured: 90 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Measured: Baseline
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Measured: 30 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Measured: 60 days
Body Mass Index (BMI)
Weight in kg and height in meters will be used to calculate BMI
Measured: 90 days
Waist circumference in centimeters
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Measured: Baseline
Waist circumference in centimeters
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Measured: 30 days
Waist circumference in centimeters
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Measured: 60 days
Waist circumference in centimeters
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Measured: 90 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Measured: Baseline
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Measured: 30 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Measured: 60 days
Height in centimeters
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Measured: 90 days
Blood sample
blood: collection after 12 hours of fasting, with evaluation of lipid profile (total cholesterol, triglycerides, low-density LDL cholesterol, high-density HDL cholesterol, very low-density VLDL cholesterol), blood glucose, glycated hemoglobin (HbA1c), inflammatory markers C-reactive protein (CRP-T) and tumor necrosis factor (TNF).
Measured: Baseline
Blood sample
blood: collection after 12 hours of fasting, with evaluation of lipid profile (total cholesterol, triglycerides, low-density LDL cholesterol, high-density HDL cholesterol, very low-density VLDL cholesterol), blood glucose, glycated hemoglobin (HbA1c), inflammatory markers C-reactive protein (CRP-T) and tumor necrosis factor (TNF).
Measured: 90 days
Genetic Analysis
Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Apr 2025
- Primary completion1 Aug 2025
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutrindo Ideais Research Center
- Sponsor type
- Research network
- Collaborators
- Universidade Federal do Rio de Janeiro
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978504
- Sponsor's protocol ID
- 79705724.2.0000.5257
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Impact of Genetic Polymorphisms and DASH Diet On Weight Loss Progression In Climacteric Women With Metabolic Syndrome?
- ClinicalTrials.gov ID
- NCT06978504
- Acronym / sponsor ID
- 79705724.2.0000.5257
- Conditions
- Nutrition, Metabolic Syndrome, Obesity, Weight Loss, Genetic Polymorphisms
- Keywords
- Dash, Nutrition, Weight Loss, metabolic Syndrome, genetic polymorphisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nutrindo Ideais Research CenterResearch network
- Collaborators
- Universidade Federal do Rio de Janeiro
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 18 May 2025 (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.
Metabolic syndrome is a multifactorial inflammatory condition that is very prevalent in overweight women with type 2 diabetes. However, there seems to be great benefit in changing lifestyle and dietary patterns in the treatment of this condition. Currently, few studies have shown the effect of a Dietary Approach to Stop Hypertension (DASH) diet in postmenopausal women with metabolic syndrome and the influence of genetic polymorphisms of the fat mass and obesity-associated protein (FTO) and beta-2 adrenergic receptor (ADRB2) genes on inflammatory markers and improvement of laboratory indicators in these patients. This study aims to analyze the interaction of polymorphisms in the ADRB2 and FTO genes and the DASH diet on anthropometric indicators and laboratory tests in patients with metabolic syndrome in the city of Rio de Janeiro. For this purpose, laboratory tests and anthropometric data will be collected in a prospective study with women aged between 40 and 60 years.
Detailed description
Prospective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90, and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that the nutritionist will apply. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90.
Only one nutritionist will make the dietary prescription to maintain the standardization of the research. The diets will be previously calculated, varying from 100 to 100 kcal (1400 to 2600 kcal) based on the patients' total energy value (TEV). The isocaloric, balanced, and individualized diet will be calculated according to the resting metabolic rate (RMR) obtained by the prediction equation and multiplied by the corresponding activity factor to obtain the TEV. The DASH eating plan will consist of fruits, vegetables, legumes, whole grains, and low-fat dairy products. White meat will be prioritized over red meat, seeds and oilseeds will be included, and sweets and foods rich in sodium will be limited.
Dietary assessment will be performed using periodic dietary record forms (24-hour records) for three non-consecutive days, two typical days, and one atypical day, to analyze the participants' eating habits before the dietary intervention. The participants will complete periodic records at seven points before the intervention begins at t15, t30, t45, t60, t75, and at the end of the 90-day study. The nutritionist will review all forms to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation) and notes that could raise questions later (few items recorded, unknown foods, errors in household measurements, and absence of any meal).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: DASH diet30 menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have in-person and online consultations with a nutritionist every 15 days for 3 months to assess their previous habitual food intake and their nutritional adherence to DASH Diet. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The study population will consist of menopausal women aged between 40 to 60 years old
- Obese (BMI > 30) with a diagnosis of MS.
- The inclusion criteria are the presence of at least 3 of the 5 criteria for MS, which include:
- Abnormal waist circumference values (≥89 cm in women)
- SBP ≥120 mm Hg and DBP ≥80 mm Hg) or diagnosis of hypertension
Key exclusion criteria (9 listed)
- Patients with a BMI <25 kg/m2
- Active cancer
- Active tuberculosis
- Psychiatric illnesses
- Multiple sclerosis
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 |
|---|---|---|
| DASH dietProspective, single-arm, unblinded clinical trial lasting 90 days. The study population will consist of menopausal women aged between 40 and 60 years who are obese (BMI > 30) and diagnosed with metabolic syndrome. Volunteers will have an in-person consultation with a nutritionist at t0 to assess their previous habitual food intake and will receive a DASH diet. To minimize losses during the study, in-person consultations with a nutritionist will be held at t0, t30, t60, t90 and online consultations (teleconsultation) at t15, t45 and t75 to answer a questionnaire to assess nutritional adherence that will be applied by the nutritionist. Saliva samples will be collected for genetic panel analysis only at t90. Serum samples for analysis of lipid profile, blood glucose, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), follicle stimulating hormone (FSH), C-reactive protein (CRP) and tumor necrosis factor (TNF) and profile of medications used will be collected at t0 and t90. | Other | Group 1 |
Primary outcome
Systolic and Diastolic blood pressure in mmHg
Time frame: Baseline
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Systolic and Diastolic blood pressure in mmHg
Time frame: 30 days
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Systolic and Diastolic blood pressure in mmHg
Time frame: 60 days
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Systolic and Diastolic blood pressure in mmHg
Time frame: 90 days
After the subject has rested for five minutes in a sitting position, blood pressure measurements will be taken using an Omron IntelliSense® Blood Pressure Monitor and an arm cuff suitable for the body size. Three readings will be taken at five-minute intervals, and the average of the three measurements will be used.
Body composition and body fat percentage
Time frame: Baseline
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Body composition and body fat percentage
Time frame: 30 days
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Body composition and body fat percentage
Time frame: 60 days
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Body composition and body fat percentage
Time frame: 90 days
Body composition (fat and lean body mass) will be measured by bioelectric impedance using an Inbody 770 (EUA)
Periodic dietary record forms (24h record)
Time frame: Baseline
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Periodic dietary record forms (24h record)
Time frame: 30 days
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Periodic dietary record forms (24h record)
Time frame: 60 days
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Periodic dietary record forms (24h record)
Time frame: 90 days
Periodic records will be completed by participants and reviewed by the nutritionist to check for any missing information (number of meals, added sugar, spoon size, quantity consumed, and type of preparation).
Body Mass Index (BMI)
Time frame: Baseline
Weight in kg and height in meters will be used to calculate BMI
Body Mass Index (BMI)
Time frame: 30 days
Weight in kg and height in meters will be used to calculate BMI
Body Mass Index (BMI)
Time frame: 60 days
Weight in kg and height in meters will be used to calculate BMI
Body Mass Index (BMI)
Time frame: 90 days
Weight in kg and height in meters will be used to calculate BMI
Waist circumference in centimeters
Time frame: Baseline
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Waist circumference in centimeters
Time frame: 30 days
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Waist circumference in centimeters
Time frame: 60 days
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Waist circumference in centimeters
Time frame: 90 days
A certified non-stretch tape measure will be used to measure waist circumference (WC) at the natural waist (midway between the 10th rib and the iliac crest), as recommended by the World Health Organization, and hip circumference over the widest point over the buttocks to the nearest centimeter.
Height in centimeters
Time frame: Baseline
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Height in centimeters
Time frame: 30 days
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Height in centimeters
Time frame: 60 days
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Height in centimeters
Time frame: 90 days
Height will be measured to the nearest 0.1 cm using a certified stadiometer
Blood sample
Time frame: Baseline
blood: collection after 12 hours of fasting, with evaluation of lipid profile (total cholesterol, triglycerides, low-density LDL cholesterol, high-density HDL cholesterol, very low-density VLDL cholesterol), blood glucose, glycated hemoglobin (HbA1c), inflammatory markers C-reactive protein (CRP-T) and tumor necrosis factor (TNF).
Blood sample
Time frame: 90 days
blood: collection after 12 hours of fasting, with evaluation of lipid profile (total cholesterol, triglycerides, low-density LDL cholesterol, high-density HDL cholesterol, very low-density VLDL cholesterol), blood glucose, glycated hemoglobin (HbA1c), inflammatory markers C-reactive protein (CRP-T) and tumor necrosis factor (TNF).
Genetic Analysis
Time frame: 90 days
Using the Real Time Polymerase Chain Reaction (real-time PCR) system on Step One PlusTM equipment
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes
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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?
A study testing DASH diet in people with Nutrition and Metabolic Syndrome, run by Nutrindo Ideais Research Center at 1 site in Brazil.
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 8 inclusion and 9 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 4 Aug 2026. 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 Brazil. 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 and Diastolic blood pressure in mmHg (time frame: Baseline). The study lists 27 primary outcomes in all. 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 4 Aug 2026.