Obesity and OverweightNCT07012226
Comparison of Cardiometabolic Markers in Individuals With Hypertriglyceridemia With Low and High Weight Loss Responses to an Energy-restricted Diet
A study testing Low-calorie diet in people with Obesity and Overweight and Hypertriglyceridaemia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Total RNA is extracted from isolated white blood cells, and cDNA is synthesized from these samples. Subsequently, the expression levels of the SIRT1 and leptin receptor genes are determined through quantitative PCR. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity and Overweight, Hypertriglyceridaemia
- What is being tested?
- Low-calorie diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 10 Jun 2025to 27 Jan 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate hypertriglyceridemia (TG=150-500 mg/dL)
- Body mass index (BMI) greater than 25
- Not using fibrates
Who cannot join
- Advanced chronic kidney disease patients
- Patients with liver cirrhosis
- Unwillingness to continue cooperating with the study
- Any change in the treatment plan during the study, including changes in the type and dose of medications taken or the start of medications that affect blood lipids
Trial locations and contacts
1 site in 1 country.
Iran1 site
Nutrition Clinic located in the Faculty of Nutrition Sciences, Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province
About this study
Official title: Effects of an Energy-restricted Diet on the Expression of the Sirtuin-1 and Leptin Receptor Genes in White Blood Cells, and Cardiometabolic Markers in Individuals With Hypertriglyceridemia: Comparison Between Low and High Weight Loss Responders
Total RNA is extracted from isolated white blood cells, and cDNA is synthesized from these samples. Subsequently, the expression levels of the SIRT1 and leptin receptor genes are determined through quantitative PCR.
Read the detailed description
Hypertriglyceridemia (HTG), defined as fasting triglycerides (TGs) ≥150 mg/dL, is a prevalent condition in the adult population, with an increasing prevalence that parallels the rise in obesity rates. There is a robust body of literature indicating a correlation between mild to moderate HTG and a number of complications, including cardiovascular disease and pancreatitis.
Lifestyle changes and weight loss could improve HTG. Dietary calorie restriction is a cornerstone in the weight loss program. However, the rate of achieving substantial weight loss through dietary interventions is often not high. Consequently, identifying factors associated with responders to both desirable and undesirable weight loss before initiating dietary interventions can help individuals struggling with weight loss. In this context, gene expression markers have been proposed as promising tools. For instance, a number of studies have identified predictors of body weight and improvement in glycemic status by comparing the transcriptomic profile of adipose tissue from obese and overweight individuals during a low-calorie diet. In other studies, peripheral blood cells have been utilized for the examination of gene expression profiles. Peripheral blood cells, including white blood cells, are readily available and, express most of the human genome. Consequently, they can reflect the gene expression of key tissues affecting energy homeostasis in response to nutritional changes or weight change. Sirtuin-1 (SIRT1) gene expression, a known regulator of glucose and lipid homeostasis, is altered by caloric restriction and weight loss. It is possible that the basal level of SIRT-1 expression may predict the metabolic response to weight loss. Conversely, leptin exerts influence over several physiological processes, including communication with the central nervous system, energy expenditure, and food intake. Obese individuals may exhibit higher levels of leptin resistance and reduced access to the central nervous system via the blood-brain barrier in comparison to lean individuals. The extent of leptin receptor expression may serve as a determining factor in these disparities. Consequently, the level of leptin receptor expression may also influence the response of individuals to a weight loss program.
The present study aims to evaluate the expression of SIRT-1 and leptin receptor genes in white blood cells and changes in cardiometabolic factors in individuals with hypertriglyceridemia associated with overweight and obesity. The variables will be compared at the beginning and end of the study between those who have lost less weight after two months and those who have lost more weight. The relationship of these variables to the percentage of weight loss will also be examined. The primary hypothesis posited that specific pre-weight loss factors could predict optimal weight loss responders. Secondary hypotheses were formulated with the objective of investigating how cardiometabolic markers would be affected by weight loss in response to a hypocaloric diet in subjects with HTG.
Methods:
The study population consists of people with mild to moderate hypertriglyceridemia who are overweight or obese and are placed on a low-calorie diet program.
Inclusion criteria:
- Mild to moderate hypertriglyceridemia (TG=150-500 mg/dL)
- Body mass index (BMI) greater than 25
- Not using fibrates
Exclusion criteria:
- Advanced chronic kidney disease patients
- Patients with liver cirrhosis
- Any change in the treatment plan during the study, including changes in the type and dose of medications taken or the start of medications that affect blood lipids.
All individuals deemed eligible will be placed on a low-calorie diet. The duration of the study is 2 months. To this end, the Mifflin formula is employed to calculate the requisite calories, with the level of physical activity factored into the calculation to determine the daily calorie requirement. Subsequently, 500 calories are deducted from this figure to derive a low-calorie diet. The determination of food groups is then based on their respective caloric content, with carbohydrates assigned a value of 50% of calories and protein assigned a value of 20% of calories. Carbohydrates should be obtained primarily from foods with a low to medium glycemic index, and simple sugars (monosaccharides, disaccharides) should be strictly limited. Patients are encouraged to choose healthy fats (monounsaturated and polyunsaturated fats). The duration of the study is 2 months.
At the end of the study, participants will be divided into tertiles based on the percentage of weight loss during the two-month period. Subsequent comparisons of study outcomes will be made between tertile 1 and tertile 3.
Venous blood samples will be collected from all patients following an overnight fast in to heparinized tubes. Following the centrifugation of the whole blood sample, the plasma is initially separated and subsequently frozen until the test is conducted. Additionally, the buffy coat, which contains leukocytes and is delineated by the interface between plasma at the superior aspect and red blood cells at the inferior aspect, is separated. Subsequent to this separation, the RNA Later solution is added to the buffy coat, which is then stored in a freezer. Total RNA will be extracted from isolated white blood cells using Trizol, and cDNA will be synthesized from these samples. Subsequently, the relative expression levels of the leptin receptor and SIRT-1 genes are determined through the use of specific primers and SYBR green master mix and Step-one plus system. The plasma sample is analyzed to measure several key parameters, including the lipid profile, insulin, leptin, adiponectin, C-reactive protein, and interleukin-6, by using commercial kits. The data will undergo analysis using SPSS software.
- Conditions
- Obesity and Overweight, Hypertriglyceridaemia
- Being tested
- Low-calorie diet
- Medical subject headings
- Obesity, Overweight, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-calorie dietOther
Low-calorie diet based on calculated calorie needs
| Study group | Role | What they receive |
|---|---|---|
| Low-calorie diet | Other | Low-calorie diet Receives: Other: Low-calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression of SIRT1
Expression levels of SIRT1 gene in white blood cells
Measured: up to 2 months
Plasma lipid profile
The plasma concentrations of triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Measured: up to 2 months
Secondary outcomes (3)
Plasma adipokines
Plasma concentrations of adiponectin, leptin, and insulin.
Measured: up to 2 months
Gene expression of leptin receptor
Gene expression of the leptin receptor in leukocytes
Measured: up to 2 months
Plasma inflammatory markers
Plasma concentrations of the inflammatory markers C-reactive protein and interleukin-6
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jun 2025
- Primary completion12 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javad Nasrollahzadeh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012226
- Sponsor's protocol ID
- 43014022
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have access to a reputable external site to share IPD information.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Energy-restricted Diet on the Expression of the Sirtuin-1 and Leptin Receptor Genes in White Blood Cells, and Cardiometabolic Markers in Individuals With Hypertriglyceridemia: Comparison Between Low and High Weight Loss Responders
- ClinicalTrials.gov ID
- NCT07012226
- Acronym / sponsor ID
- 43014022
- Conditions
- Obesity and Overweight, Hypertriglyceridaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 10 Jun 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.
Total RNA is extracted from isolated white blood cells, and cDNA is synthesized from these samples. Subsequently, the expression levels of the SIRT1 and leptin receptor genes are determined through quantitative PCR.
Detailed description
Hypertriglyceridemia (HTG), defined as fasting triglycerides (TGs) ≥150 mg/dL, is a prevalent condition in the adult population, with an increasing prevalence that parallels the rise in obesity rates. There is a robust body of literature indicating a correlation between mild to moderate HTG and a number of complications, including cardiovascular disease and pancreatitis.
Lifestyle changes and weight loss could improve HTG. Dietary calorie restriction is a cornerstone in the weight loss program. However, the rate of achieving substantial weight loss through dietary interventions is often not high. Consequently, identifying factors associated with responders to both desirable and undesirable weight loss before initiating dietary interventions can help individuals struggling with weight loss. In this context, gene expression markers have been proposed as promising tools. For instance, a number of studies have identified predictors of body weight and improvement in glycemic status by comparing the transcriptomic profile of adipose tissue from obese and overweight individuals during a low-calorie diet. In other studies, peripheral blood cells have been utilized for the examination of gene expression profiles. Peripheral blood cells, including white blood cells, are readily available and, express most of the human genome. Consequently, they can reflect the gene expression of key tissues affecting energy homeostasis in response to nutritional changes or weight change. Sirtuin-1 (SIRT1) gene expression, a known regulator of glucose and lipid homeostasis, is altered by caloric restriction and weight loss. It is possible that the basal level of SIRT-1 expression may predict the metabolic response to weight loss. Conversely, leptin exerts influence over several physiological processes, including communication with the central nervous system, energy expenditure, and food intake. Obese individuals may exhibit higher levels of leptin resistance and reduced access to the central nervous system via the blood-brain barrier in comparison to lean individuals. The extent of leptin receptor expression may serve as a determining factor in these disparities. Consequently, the level of leptin receptor expression may also influence the response of individuals to a weight loss program.
The present study aims to evaluate the expression of SIRT-1 and leptin receptor genes in white blood cells and changes in cardiometabolic factors in individuals with hypertriglyceridemia associated with overweight and obesity. The variables will be compared at the beginning and end of the study between those who have lost less weight after two months and those who have lost more weight. The relationship of these variables to the percentage of weight loss will also be examined. The primary hypothesis posited that specific pre-weight loss factors could predict optimal weight loss responders. Secondary hypotheses were formulated with the objective of investigating how cardiometabolic markers would be affected by weight loss in response to a hypocaloric diet in subjects with HTG.
Methods:
The study population consists of people with mild to moderate hypertriglyceridemia who are overweight or obese and are placed on a low-calorie diet program.
Inclusion criteria:
- Mild to moderate hypertriglyceridemia (TG=150-500 mg/dL)
- Body mass index (BMI) greater than 25
- Not using fibrates
Exclusion criteria:
- Advanced chronic kidney disease patients
- Patients with liver cirrhosis
- Any change in the treatment plan during the study, including changes in the type and dose of medications taken or the start of medications that affect blood lipids.
All individuals deemed eligible will be placed on a low-calorie diet. The duration of the study is 2 months. To this end, the Mifflin formula is employed to calculate the requisite calories, with the level of physical activity factored into the calculation to determine the daily calorie requirement. Subsequently, 500 calories are deducted from this figure to derive a low-calorie diet. The determination of food groups is then based on their respective caloric content, with carbohydrates assigned a value of 50% of calories and protein assigned a value of 20% of calories. Carbohydrates should be obtained primarily from foods with a low to medium glycemic index, and simple sugars (monosaccharides, disaccharides) should be strictly limited. Patients are encouraged to choose healthy fats (monounsaturated and polyunsaturated fats). The duration of the study is 2 months.
At the end of the study, participants will be divided into tertiles based on the percentage of weight loss during the two-month period. Subsequent comparisons of study outcomes will be made between tertile 1 and tertile 3.
Venous blood samples will be collected from all patients following an overnight fast in to heparinized tubes. Following the centrifugation of the whole blood sample, the plasma is initially separated and subsequently frozen until the test is conducted. Additionally, the buffy coat, which contains leukocytes and is delineated by the interface between plasma at the superior aspect and red blood cells at the inferior aspect, is separated. Subsequent to this separation, the RNA Later solution is added to the buffy coat, which is then stored in a freezer. Total RNA will be extracted from isolated white blood cells using Trizol, and cDNA will be synthesized from these samples. Subsequently, the relative expression levels of the leptin receptor and SIRT-1 genes are determined through the use of specific primers and SYBR green master mix and Step-one plus system. The plasma sample is analyzed to measure several key parameters, including the lipid profile, insulin, leptin, adiponectin, C-reactive protein, and interleukin-6, by using commercial kits. The data will undergo analysis using SPSS software.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-calorie diet | Other | Other: Low-calorie dietLow-calorie diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate hypertriglyceridemia (TG=150-500 mg/dL)
- Body mass index (BMI) greater than 25
- Not using fibrates
Key exclusion criteria (4 listed)
- Advanced chronic kidney disease patients
- Patients with liver cirrhosis
- Unwillingness to continue cooperating with the study
- Any change in the treatment plan during the study, including changes in the type and dose of medications taken or the start of medications that affect blood lipids
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 |
|---|---|---|
| Low-calorie dietLow-calorie diet based on calculated calorie needs | Other | Low-calorie diet |
Primary outcome
Gene expression of SIRT1
Time frame: up to 2 months
Expression levels of SIRT1 gene in white blood cells
Plasma lipid profile
Time frame: up to 2 months
The plasma concentrations of triglycerides, cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
3 secondary outcomes
Plasma adipokines
Time frame: up to 2 months
Gene expression of leptin receptor
Time frame: up to 2 months
Plasma inflammatory markers
Time frame: up to 2 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 28 Jan 2026.
- Individual participant dataSharing planned: No. I do not have access to a reputable external site to share IPD information.
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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 Low-calorie diet in people with Obesity and Overweight and Hypertriglyceridaemia, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 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 28 Jan 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 Iran. 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?
Gene expression of SIRT1 (time frame: up to 2 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?
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 28 Jan 2026.