DyslipidemiaNCT07871565
Time-Restricted Eating With or Without Energy Restriction in Dyslipidemic Women With Owerweight or Obesity
A study testing TRE, ER, TRE+ER in people with Dyslipidemia and Obesity & Overweight, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Background/Objectives: It is unclear whether the effects of time-restricted eating (TRE) on body composition and blood lipids are independent of energy restriction (ER), and whether combining the two confers additional benefit. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Dyslipidemia, Obesity & Overweight
- What is being tested?
- TRE, ER, TRE+ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Jul 2024
- 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 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were sedentary women aged 19-65 years with overweight or obesity (BMI ≥ 25 kg/m²) who had received a physician diagnosis of dyslipidemia but were not taking lipid-lowering medication, and who volunteered to take part.
Who cannot join
- Pregnancy or lactation
- Shift work
- smoking
- excessive alcohol consumption
- a major adverse cardiovascular event in the previous year (acute coronary syndrome, percutaneous coronary interven-tion, coronary artery bypass grafting, hospitalization for congestive heart failure, stroke or transient ischemic attack)
- uncontrolled arrhythmia
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- diabetes mellitus or reactive hypo-glycemia
- congenital or immunological disease
- acute pancreatitis, cirrhosis or malignancy
- a diagnosed eating disorder
- stage 4 or 5 chronic kidney disease or dialysis treatment
- any concurrent medical nutrition therapy prescribed for another indication (e.g., celiac disease)
- previous bariatric surgery
- thyroid disease requiring dose titration of replacement therapy within the previous three months (stable replacement therapy for hypothyroidism was not an exclusion criterion)
- a major psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-Restricted Eating With or Without Energy Restriction in Dyslipidemic Women With Owerweight or Obesity: An 8-Week Three-Arm Randomized Controlled Trial
Background/Objectives: It is unclear whether the effects of time-restricted eating (TRE) on body composition and blood lipids are independent of energy restriction (ER), and whether combining the two confers additional benefit. Methods: In this prospective, 8-week, three-arm, parallel-group randomized controlled trial, 85 sedentary women aged 19-65 years with overweight/obesity and untreated dyslipidemia were allocated to TRE (16:8, ad libitum intake within a 12:00-20:00 window), ER (individually calculated diet providing approximately 500 kcal/day below total energy expenditure) or TRE + ER. Anthropometry and bioelectrical impedance analysis were performed at baseline, week 4 and week 8, and fasting biochemistry at baseline and week 8.
- Conditions
- Dyslipidemia, Obesity & Overweight
- Being tested
- TRE, ER, TRE+ER
- Keywords
- time-restricted eating, intermittent fasting, energy restriction, obesity, dyslipidemia, body composition, lipid profile, chrononuftrition, women
- Medical subject headings
- Dyslipidemias, Obesity, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRE, ER, TRE+EROther
The TRE arm followed a 16:8 protocol [23]: all food was consumed within an 8-h window from 12:00 to 20:00, and the remaining 16 h were spent fasting. Within the eating window participants ate ad libitum and received no guidance on food quantity or composition. During the 16-h fasting period only energy-free beverages (water, tea and coffee without added energy) were permitted. Participants in the TRE + ER arm followed the same 12:00-20:00 window while also adhering to the individually prescribed en-ergy-restricted diet described above.
| Study group | Role | What they receive |
|---|---|---|
| TRE alone | Experimental | TRE alone Receives: Other: TRE, ER, TRE+ER |
| TRE combined with ER | Experimental | TRE combined with ER Receives: Other: TRE, ER, TRE+ER |
| ER alone | Active comparator | ER alone Receives: Other: TRE, ER, TRE+ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight (kg)
Body weight was assessed at baseline, week 4, and week 8. Body weight was measured in kilograms (kg)
Measured: 8 weeks
Change in BMI (kg/m²).
Body Mass Index (BMI) was assessed at baseline, week 4, and week 8. BMI was calculated in kilograms per square meter (kg/m²).
Measured: 8 weeks.
Change in Waist Circumference (cm)
Waist circumference was assessed at baseline, week 4, and week 8. Waist circumference was measured in centimeters (cm).
Measured: 8 weeks.
Change in Hip Circumference (cm)
Hip circumference was assessed at baseline, week 4, and week 8. Hip circumference was measured in centimeters (cm).
Measured: 8 weeks.
Change in Fat Mass (kg)
Fat mass was assessed at baseline, week 4, and week 8. Fat mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Measured: 8 weeks.
Change in Fat-Free Mass (kg)
Fat-free mass was assessed at baseline, week 4, and week 8. Fat-free mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Measured: 8 weeks.
Change in Skeletal Muscle Mass (kg)
Skeletal muscle mass was assessed at baseline, week 4, and week 8. Skeletal muscle mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Measured: 8 weeks
Change in Total Cholesterol (mg/dL)
Total cholesterol was assessed at baseline and week 8. Total cholesterol was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in LDL Cholesterol (mg/dL)
LDL cholesterol was assessed at baseline and week 8. LDL cholesterol was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in HDL Cholesterol (mg/dL)
HDL cholesterol was assessed at baseline and week 8. HDL cholesterol was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in Triglycerides (mg/dL)
Triglycerides was assessed at baseline and week 8. Triglycerides was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in HbA1C (%)
HbA1C was assessed at baseline and week 8. HbA1C was measured as a percentage (%).
Measured: 8 weeks.
Change in Waist-to-Hip Ratio
Waist-to-hip ratio was assessed at baseline, week 4, and week 8.
Measured: 8 weeks
Change in Body Fat Percentage (%)
Body fat percentage was assessed at baseline, week 4, and week 8. Body fat percentage was measured as a percentage (%).
Measured: 8 weeks
Change in Fat-Free Mass Percentage (%)
Fat-free mass percentage was assessed at baseline, week 4, and week 8. Fat-free mass percentage was measured as a percentage (%)
Measured: 8 weeks
Change in VLDL Cholesterol (mg/dL)
VLDL cholesterol was assessed at baseline, and week 8. VLDL cholesterol was measured in milligrams per deciliter (mg/dL)
Measured: 8 weeks
Change in Fasting Plasma Glucose (mg/dL)
Fasting plasma glucose was assessed at baseline and week 8. Fasting plasma glucose was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Change in AST (U/L)
AST was assessed at baseline and week 8. AST was measured in units per liter (U/L)
Measured: 8 weeks
Change in ALT (U/L)
ALT was assessed at baseline and week 8. ALT was measured in units per liter (U/L)
Measured: 8 weeks
Change in TIBC (μg)
Total iron-binding capacity was assessed at baseline and week 8.Total iron-binding capacity was measured in micrograms per deciliter (μg/dL).
Measured: 8 weeks
Change in Ferritin (ng/mL)
Ferritin was assessed at baseline and week 8. Ferritin was measured in nanogram per milliliter (ng/mL)
Measured: 8 weeks
Change in Creatinine (mg/dL)
Creatinine was assessed at baseline and week 8. Creatinine was measured in milligrams per deciliter (mg/dL).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Feb 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Murat BAS, Professor, Study director, Acibadem UniversityGözde ARITICI COLAK, Associate Professor, Study director, Acibadem UniversityIrem OZKAN, pHD, Principal investigator, Istanbul Public Health Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871565
- Sponsor's protocol ID
- ATADEK 2022-01/41
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating With or Without Energy Restriction in Dyslipidemic Women With Owerweight or Obesity: An 8-Week Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07871565
- Acronym / sponsor ID
- ATADEK 2022-01/41
- Conditions
- Dyslipidemia, Obesity & Overweight
- Keywords
- time-restricted eating, intermittent fasting, energy restriction, obesity, dyslipidemia, body composition, lipid profile, chrononuftrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 13 Oct 2026 (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.
Background/Objectives: It is unclear whether the effects of time-restricted eating (TRE) on body composition and blood lipids are independent of energy restriction (ER), and whether combining the two confers additional benefit. Methods: In this prospective, 8-week, three-arm, parallel-group randomized controlled trial, 85 sedentary women aged 19-65 years with overweight/obesity and untreated dyslipidemia were allocated to TRE (16:8, ad libitum intake within a 12:00-20:00 window), ER (individually calculated diet providing approximately 500 kcal/day below total energy expenditure) or TRE + ER. Anthropometry and bioelectrical impedance analysis were performed at baseline, week 4 and week 8, and fasting biochemistry at baseline and week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TRE alone | Experimental | Other: TRE, ER, TRE+ERTRE alone |
| TRE combined with ER | Experimental | Other: TRE, ER, TRE+ERTRE combined with ER |
| ER alone | Active comparator | Other: TRE, ER, TRE+ERER alone |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were sedentary women aged 19-65 years with overweight or obesity (BMI ≥ 25 kg/m²) who had received a physician diagnosis of dyslipidemia but were not taking lipid-lowering medication, and who volunteered to take part.
Key exclusion criteria (15 listed)
- Pregnancy or lactation
- Shift work
- smoking
- excessive alcohol consumption
- a major adverse cardiovascular event in the previous year (acute coronary syndrome, percutaneous coronary interven-tion, coronary artery bypass grafting, hospitalization for congestive heart failure, stroke or transient ischemic attack)
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 |
|---|---|---|
| TRE, ER, TRE+ERThe TRE arm followed a 16:8 protocol [23]: all food was consumed within an 8-h window from 12:00 to 20:00, and the remaining 16 h were spent fasting. Within the eating window participants ate ad libitum and received no guidance on food quantity or composition. During the 16-h fasting period only energy-free beverages (water, tea and coffee without added energy) were permitted. Participants in the TRE + ER arm followed the same 12:00-20:00 window while also adhering to the individually prescribed en-ergy-restricted diet described above. | Other | ER alone, TRE alone, TRE combined with ER |
Primary outcome
Change in Body Weight (kg)
Time frame: 8 weeks
Body weight was assessed at baseline, week 4, and week 8. Body weight was measured in kilograms (kg)
Change in BMI (kg/m²).
Time frame: 8 weeks.
Body Mass Index (BMI) was assessed at baseline, week 4, and week 8. BMI was calculated in kilograms per square meter (kg/m²).
Change in Waist Circumference (cm)
Time frame: 8 weeks.
Waist circumference was assessed at baseline, week 4, and week 8. Waist circumference was measured in centimeters (cm).
Change in Hip Circumference (cm)
Time frame: 8 weeks.
Hip circumference was assessed at baseline, week 4, and week 8. Hip circumference was measured in centimeters (cm).
Change in Fat Mass (kg)
Time frame: 8 weeks.
Fat mass was assessed at baseline, week 4, and week 8. Fat mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Change in Fat-Free Mass (kg)
Time frame: 8 weeks.
Fat-free mass was assessed at baseline, week 4, and week 8. Fat-free mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Change in Skeletal Muscle Mass (kg)
Time frame: 8 weeks
Skeletal muscle mass was assessed at baseline, week 4, and week 8. Skeletal muscle mass was measured in kilograms (kg) using bioelectrical impedance analysis.
Change in Total Cholesterol (mg/dL)
Time frame: 8 weeks
Total cholesterol was assessed at baseline and week 8. Total cholesterol was measured in milligrams per deciliter (mg/dL).
Change in LDL Cholesterol (mg/dL)
Time frame: 8 weeks
LDL cholesterol was assessed at baseline and week 8. LDL cholesterol was measured in milligrams per deciliter (mg/dL).
Change in HDL Cholesterol (mg/dL)
Time frame: 8 weeks
HDL cholesterol was assessed at baseline and week 8. HDL cholesterol was measured in milligrams per deciliter (mg/dL).
Change in Triglycerides (mg/dL)
Time frame: 8 weeks
Triglycerides was assessed at baseline and week 8. Triglycerides was measured in milligrams per deciliter (mg/dL).
Change in HbA1C (%)
Time frame: 8 weeks.
HbA1C was assessed at baseline and week 8. HbA1C was measured as a percentage (%).
Change in Waist-to-Hip Ratio
Time frame: 8 weeks
Waist-to-hip ratio was assessed at baseline, week 4, and week 8.
Change in Body Fat Percentage (%)
Time frame: 8 weeks
Body fat percentage was assessed at baseline, week 4, and week 8. Body fat percentage was measured as a percentage (%).
Change in Fat-Free Mass Percentage (%)
Time frame: 8 weeks
Fat-free mass percentage was assessed at baseline, week 4, and week 8. Fat-free mass percentage was measured as a percentage (%)
Change in VLDL Cholesterol (mg/dL)
Time frame: 8 weeks
VLDL cholesterol was assessed at baseline, and week 8. VLDL cholesterol was measured in milligrams per deciliter (mg/dL)
Change in Fasting Plasma Glucose (mg/dL)
Time frame: 8 weeks
Fasting plasma glucose was assessed at baseline and week 8. Fasting plasma glucose was measured in milligrams per deciliter (mg/dL).
Change in AST (U/L)
Time frame: 8 weeks
AST was assessed at baseline and week 8. AST was measured in units per liter (U/L)
Change in ALT (U/L)
Time frame: 8 weeks
ALT was assessed at baseline and week 8. ALT was measured in units per liter (U/L)
Change in TIBC (μg)
Time frame: 8 weeks
Total iron-binding capacity was assessed at baseline and week 8.Total iron-binding capacity was measured in micrograms per deciliter (μg/dL).
Change in Ferritin (ng/mL)
Time frame: 8 weeks
Ferritin was assessed at baseline and week 8. Ferritin was measured in nanogram per milliliter (ng/mL)
Change in Creatinine (mg/dL)
Time frame: 8 weeks
Creatinine was assessed at baseline and week 8. Creatinine was measured in milligrams per deciliter (mg/dL).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murat BAS, Professor study director
Acibadem University
Gözde ARITICI COLAK, Associate Professor study director
Acibadem University
Irem OZKAN, pHD principal investigator
Istanbul Public Health Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRE, ER, TRE+ER in people with Dyslipidemia and Obesity & Overweight, run by Acibadem 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 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 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?
Change in Body Weight (kg) (time frame: 8 weeks). The study lists 22 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 13 Oct 2026.