OverweightNCT06270810
Cardiometabolic Effects of Combined Aerobic Exercise and Non-Exercise Physical Activity
A study testing Aerobic Exercise and Increasing non-Exercise Physical Activity in people with Overweight, run by Kastamonu University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Aerobic Exercise and Increasing non-Exercise Physical Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2024to 1 Sep 2025
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To have a body mass index between 25 kg.(m2)-1 and 29.9 kg.(m2)-1
- Self reported sitting time greater than 7 hours per day
- Not exercising regularly in the last 3 months
Who cannot join
- Hypertension
- Coronary heart disease
- Heart failure
- Diabetes mellitus (A1C being 6.5% and above)
- Prediabetes (A1C between 5.7% and 6.4%)
- Metabolic syndrome
Show all 19Show fewer
- Hypothyroidism
- Non-alcoholic fatty liver disease
- Chronic inflammatory disease
- Chronic renal failure
- Cushing's syndrome
- Musculoskeletal disorder that will affect the ability to do physical activity
- HIV infection
- Being on antihypertensive medication
- Being on lipid-lowering medication
- Being on antidiabetic medication
- Being on systemic glucocorticoid medication
- Smoking
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kastamonu University, Çatalzeytin Vocational School
Çatalzeytin, Kastamonu, 37
About this study
Official title: Cardiometabolic Effects of Increasing Non-Exercise Physical Activity Combined With Aerobic Exercise in Overweight Young Women
The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.
The main question it aims to answer is:
Read more
- Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?
To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables.
Read the detailed description
According to objective and subjective measurements, time spent sedentary varies between 2.5 hours and 10 hours approximately in European countries. In America, this time is 8.44 hours on average. According to accelerometer data, the average total sedentary time of university students is 9.82 hours per day. Sedentary behaviour (SB) is associated with cardiometabolic risk markers and increased risk of cardiovascular disease, independent of moderate and vigorous physical activity (PA). Replacing sedentary time with PA of any intensity, including low-intensity, reduces all-cause mortality.
In terms of some cardiovascular risk variables (e.g., high triglycerides, glucose, LDL cholesterol, total cholesterol), data are insufficient and conflicting on the superiority of increasing non-exercise PA in addition to aerobic exercise over aerobic exercise alone. Additionally, to our knowledge, whether increasing non-exercise PA combined with aerobic exercise is superior to performing aerobic exercise alone in young overweight women with high sedentary time has not been investigated. Therefore, this study was planned to investigate whether reducing SB and increasing non-exercise PA combined with aerobic exercise in overweight young women between the ages of 18-35 is superior to performing aerobic exercise alone in terms of some cardiometabolic variables. For this purpose, overweight female individuals between the ages of 18-35 will be invited to the research. Thirty-two female volunteers who meet the inclusion and exclusion criteria will be randomly assigned to two different groups of this research. These groups will be as follows:
Aerobic Exercise Group: Participants in this group will do moderate-intensity aerobic training four days a week for 8 weeks.
Aerobic Exercise+non-Exercise Physical Activity Group: Participants in this group will reduce their sedentary time and increase non-exercise PA in addition to moderate-intensity aerobic training for four days a week for 8 weeks.
PA and SB data of the participants in both groups will be monitored with a wrist worn accelerometer throughout the study. At the beginning of the study, 4 weeks after the beginning and at the end of 8 weeks, participants will be evaluated in terms of the cardiometabolic variables. These variables are fasting serum glucose, triglyceride, HDL cholesterol, LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, cardiorespiratory fitness, body mass index, waist and hip circumference, and body fat percentage. If there is a difference between the two group averages in terms of all variables and the group-time interactions test assumptions are met, analysis will be made with two-way mixed analysis of variance (ANOVA). Since 3 measurements will be made over time, pairwise differences in change over time will be analyzed with a post hoc Bonferroni test.
- Conditions
- Overweight
- Being tested
- Aerobic Exercise, Increasing non-Exercise Physical Activity
- Keywords
- Overweight, non-Exercise Physical Activity, Aerobic Exercise, Sedentary Behaviour, Physical Activity, Step Counts, Cardiometabolic, Blood Lipids, Serum Glucose, HbA1c, Blood Pressure, Young Women, Cardiorespiratory Fitness
- Medical subject headings
- Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Aerobic exercise will be performed on the treadmill at 40-60% of the participants' heart rate reserves. Each aerobic exercise session will last for 40 minutes. All participants will be monitored with a heart rate monitor throughout the exercise sessions. During the first three-week, participants will exercise on the treadmill at intensities between 40-50%, and between fourth and eighth weeks, 50-60% of their heart rate reserves. Participants will wear an accelerometer on their non-dominant wrist during the intervention to monitor the physical activity and sedentary behavior data. At the same time, these participants will be asked not to change their routine diet during the intervention period.
Increasing non-Exercise Physical ActivityBehavioural
Participants who will carry out this intervention will increase their non-exercise physical activities. Before intervention period, participants will receive face-to-face training to increase their non-exercise physical activities. This training will generally consist of recommendations based on the study which effectively reduced sedentary behavior (SB) with non-exercise physical activities (Sarah Kozey-Keadle et al. 2012). A one-on-one interview will be held with each participant every week to learn about strategies by which the volunteers successfully increased their non-exercise physical activities in the previous week, and the difficulties or barriers they encountered. New strategies to overcome these difficulties and barriers will be discussed and suggestions will be made. Participants will wear an accelerometer on their non-dominant wrist to monitor the physical activity and SB data, and will be asked not to change their routine diet during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise (AeroEx) Group | Experimental | Participants in this group will do moderate-intensity aerobic training for 4 days a week for 8 weeks. Receives: Behavioral: Aerobic Exercise |
| Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group | Experimental | Participants in this group will increase their non-exercise physical activities and do moderate-intensity aerobic training for four days a week for 8 weeks. Receives: Behavioral: Aerobic Exercise; Behavioral: Increasing non-Exercise Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Density Lipoprotein (LDL) Cholesterol
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
High Density Lipoprotein (HDL) Cholesterol
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Total Cholesterol
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Glycated Hemoglobin (HbA1C)
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Serum Triglycerides
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Maximal Oxygen Consumption
Maximal oxygen consumption will be estimated by the Rockport 1 Mile Walk Test
Measured: The week before the beginning of the interventions, and the week after the interventions
Systolic Blood Pressure
Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial systolic blood pressure will be automatically measured.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Diastolic Blood Pressure
Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial diastolic blood pressure will be automatically measured.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Secondary outcomes (4)
Body Fat Percentage
Body fat percentage will be measured by bioelectrical impedance analysis
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fat-free Mass
Fat-free mass will be measured by bioelectrical impedance analysis
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Waist Circumference
Waist circumference will be measured in centimeters in the horizontal plane with a tape measure from the narrowest part of the waist area, with feet together, immediately after normal expiration without holding the breath.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Hip Circumference
Hip circumference will be measured in centimeters in the horizontal plane with a tape measure from the widest part of the hip.
Measured: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start11 Mar 2024
- Primary completion18 Jun 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kastamonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasin Ak, Kastamonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06270810
- Sponsor's protocol ID
- Aero-PA
- Status last verified
- Dec 2025
- First submitted
- 14 Feb 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kozey-Keadle S, Libertine A, Staudenmayer J, Freedson P. The Feasibility of Reducing and Measuring Sedentary Time among Overweight, Non-Exercising Office Workers. J Obes. 2012;2012:282303. doi: 10.1155/2012/282303. Epub 2011 Nov 16.
PubMed 22175004Kozey Keadle S, Lyden K, Staudenmayer J, Hickey A, Viskochil R, Braun B, Freedson PS. The independent and combined effects of exercise training and reducing sedentary behavior on cardiometabolic risk factors. Appl Physiol Nutr Metab. 2014 Jul;39(7):770-80. doi: 10.1139/apnm-2013-0379. Epub 2014 Jan 7.
PubMed 24971677
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Effects of Increasing Non-Exercise Physical Activity Combined With Aerobic Exercise in Overweight Young Women
- ClinicalTrials.gov ID
- NCT06270810
- Acronym / sponsor ID
- Aero-PA
- Conditions
- Overweight
- Keywords
- Overweight, non-Exercise Physical Activity, Aerobic Exercise, Sedentary Behaviour, Physical Activity, Step Counts, Cardiometabolic, Blood Lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kastamonu UniversityUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 21 Feb 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.
The goal of this clinical trial is to investigate whether increasing non-exercise physical activity combined with aerobic exercise in overweight young women is superior to performing aerobic exercise alone in terms of some cardiometabolic variables.
The main question it aims to answer is:
- Do both increasing non-exercise physical activity and doing aerobic exercise add more beneficial cardiometabolic effects to performing aerobic exercise alone in overweight young women?
To answer this question, overweight young women will be randomly assigned to two different groups of this research. Volunteers in one of the groups will do moderate-intensity aerobic training and the other group will increase their non-exercise physical activities in addition to moderate-intensity aerobic training. Then researchers will compare two groups to see the differences in cardiometabolic variables.
Detailed description
According to objective and subjective measurements, time spent sedentary varies between 2.5 hours and 10 hours approximately in European countries. In America, this time is 8.44 hours on average. According to accelerometer data, the average total sedentary time of university students is 9.82 hours per day. Sedentary behaviour (SB) is associated with cardiometabolic risk markers and increased risk of cardiovascular disease, independent of moderate and vigorous physical activity (PA). Replacing sedentary time with PA of any intensity, including low-intensity, reduces all-cause mortality.
In terms of some cardiovascular risk variables (e.g., high triglycerides, glucose, LDL cholesterol, total cholesterol), data are insufficient and conflicting on the superiority of increasing non-exercise PA in addition to aerobic exercise over aerobic exercise alone. Additionally, to our knowledge, whether increasing non-exercise PA combined with aerobic exercise is superior to performing aerobic exercise alone in young overweight women with high sedentary time has not been investigated. Therefore, this study was planned to investigate whether reducing SB and increasing non-exercise PA combined with aerobic exercise in overweight young women between the ages of 18-35 is superior to performing aerobic exercise alone in terms of some cardiometabolic variables. For this purpose, overweight female individuals between the ages of 18-35 will be invited to the research. Thirty-two female volunteers who meet the inclusion and exclusion criteria will be randomly assigned to two different groups of this research. These groups will be as follows:
Aerobic Exercise Group: Participants in this group will do moderate-intensity aerobic training four days a week for 8 weeks.
Aerobic Exercise+non-Exercise Physical Activity Group: Participants in this group will reduce their sedentary time and increase non-exercise PA in addition to moderate-intensity aerobic training for four days a week for 8 weeks.
PA and SB data of the participants in both groups will be monitored with a wrist worn accelerometer throughout the study. At the beginning of the study, 4 weeks after the beginning and at the end of 8 weeks, participants will be evaluated in terms of the cardiometabolic variables. These variables are fasting serum glucose, triglyceride, HDL cholesterol, LDL cholesterol, HbA1c, systolic blood pressure, diastolic blood pressure, cardiorespiratory fitness, body mass index, waist and hip circumference, and body fat percentage. If there is a difference between the two group averages in terms of all variables and the group-time interactions test assumptions are met, analysis will be made with two-way mixed analysis of variance (ANOVA). Since 3 measurements will be made over time, pairwise differences in change over time will be analyzed with a post hoc Bonferroni test.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise (AeroEx) Group | Experimental | Behavioral: Aerobic ExerciseParticipants in this group will do moderate-intensity aerobic training for 4 days a week for 8 weeks. |
| Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group | Experimental | Behavioral: Aerobic Exercise, Behavioral: Increasing non-Exercise Physical ActivityParticipants in this group will increase their non-exercise physical activities and do moderate-intensity aerobic training for four days a week for 8 weeks. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- To have a body mass index between 25 kg.(m2)-1 and 29.9 kg.(m2)-1
- Self reported sitting time greater than 7 hours per day
- Not exercising regularly in the last 3 months
Key exclusion criteria (19 listed)
- Hypertension
- Coronary heart disease
- Heart failure
- Diabetes mellitus (A1C being 6.5% and above)
- Prediabetes (A1C between 5.7% and 6.4%)
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 |
|---|---|---|
| Aerobic ExerciseAerobic exercise will be performed on the treadmill at 40-60% of the participants' heart rate reserves. Each aerobic exercise session will last for 40 minutes. All participants will be monitored with a heart rate monitor throughout the exercise sessions. During the first three-week, participants will exercise on the treadmill at intensities between 40-50%, and between fourth and eighth weeks, 50-60% of their heart rate reserves. Participants will wear an accelerometer on their non-dominant wrist during the intervention to monitor the physical activity and sedentary behavior data. At the same time, these participants will be asked not to change their routine diet during the intervention period. | Behavioural | Aerobic Exercise (AeroEx) Group, Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group |
| Increasing non-Exercise Physical ActivityParticipants who will carry out this intervention will increase their non-exercise physical activities. Before intervention period, participants will receive face-to-face training to increase their non-exercise physical activities. This training will generally consist of recommendations based on the study which effectively reduced sedentary behavior (SB) with non-exercise physical activities (Sarah Kozey-Keadle et al. 2012). A one-on-one interview will be held with each participant every week to learn about strategies by which the volunteers successfully increased their non-exercise physical activities in the previous week, and the difficulties or barriers they encountered. New strategies to overcome these difficulties and barriers will be discussed and suggestions will be made. Participants will wear an accelerometer on their non-dominant wrist to monitor the physical activity and SB data, and will be asked not to change their routine diet during the intervention period. | Behavioural | Aerobic Exercise+non-Exercise (nE) Physical Activity (AeroEx+nE PA) Group |
Primary outcome
Low Density Lipoprotein (LDL) Cholesterol
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
High Density Lipoprotein (HDL) Cholesterol
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Total Cholesterol
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Glycated Hemoglobin (HbA1C)
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Serum Triglycerides
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fasting blood samples will be taken by applying a vacutainer needle to the appropriate vein following a 12-hour fast and will be analyzed immediately in the biochemistry laboratory.
Maximal Oxygen Consumption
Time frame: The week before the beginning of the interventions, and the week after the interventions
Maximal oxygen consumption will be estimated by the Rockport 1 Mile Walk Test
Systolic Blood Pressure
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial systolic blood pressure will be automatically measured.
Diastolic Blood Pressure
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Measurements will be made on the arm with a digital blood pressure monitor after resting for at least 10 minutes in a supine position to ensure hemodynamic stability. By wrapping the cuff around the arm, brachial diastolic blood pressure will be automatically measured.
4 secondary outcomes
Body Fat Percentage
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Fat-free Mass
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Waist Circumference
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
Hip Circumference
Time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions
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 6 Jan 2026.
- Background: PubMed 22175004Kozey-Keadle S, Libertine A, Staudenmayer J, Freedson P. The Feasibility of Reducing and Measuring Sedentary Time among Overweight, Non-Exercising Office Workers. J Obes. 2012;2012:282303. doi: 10.1155/2012/282303. Epub 2011 Nov 16.
- Background: PubMed 24971677Kozey Keadle S, Lyden K, Staudenmayer J, Hickey A, Viskochil R, Braun B, Freedson PS. The independent and combined effects of exercise training and reducing sedentary behavior on cardiometabolic risk factors. Appl Physiol Nutr Metab. 2014 Jul;39(7):770-80. doi: 10.1139/apnm-2013-0379. Epub 2014 Jan 7.
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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 Aerobic Exercise and Increasing non-Exercise Physical Activity in people with Overweight, run by Kastamonu University at 1 site in Turkey (Türkiye).
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 6 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 Turkey (Türkiye). 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?
Low Density Lipoprotein (LDL) Cholesterol (time frame: The week before the beginning of the interventions, at 4th week of the intervention , and the week after the interventions). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06270810, which also lists 2 linked publications.
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 6 Jan 2026.