Overweight and ObesityNCT06364475
Could a Time-restricted Diet Compete With a Calorie-restricted 6-meal Diet?
A study testing 16:8 Time-Restricted Intermittent Fasting Group and Energy-Restricted Six-Meal Group in people with Overweight and Obesity, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- 16:8 Time-Restricted Intermittent Fasting Group and Energy-Restricted Six-Meal Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Sep 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 18-65
- BMI >25 kg/m2
Who cannot join
- People with a history of bariatric surgery
- Eating disorders
- Alcohol and drug addiction
- Anti-obesity medication use
- Diagnosed with diabetes and hypothyroidism
- Active cancer patients
- People carrying infectious diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Sabri Artam Vakfi Family Medicine Center
Istanbul, 34473
About this study
Official title: Comparing the Effects of Time-restricted Eating and Three Meals-three Snacks Diet on Body Composition and on Biochemical Parameters
The prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week.
Read the detailed description
Our study was conducted with participants, aged between 18-65 and with a BMI >25 kg/m2, who consulted a family medicine clinic in Istanbul, accepted the terms and conditions of the study and signed the volunteer consent form. Sample analysis was performed by T.M. with G Power 3.1.9.7 (Franz Faul, Germany), using data from Sundfør et al.'s study, "Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: a randomized 1-year trial". The effect size was assumed to be d: 0.382 for the purposes of calculation. After the calculation made with the aforementioned effect size, with 80% power and 10% margin of error, it was concluded that a cohort of at least 126 samples, of which 63 would be in the patient group and 63 would be in the control group, should be used in this study.
People with a history of bariatric surgery, eating disorders, alcohol and drug addiction, anti-obesity medication use, diagnosed with diabetes and hypothyroidism, active cancer patients and people carrying infectious diseases were excluded from the study. At the beginning of the study, 88 people were included in the 16:8 time-restricted intermittent fasting (time-restricted eating) group, with an eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein); and 86 people were included in the energy-restricted six-meal group. Diet lists suitable for each group were prepared, and food substitution lists were handed out to the participants. Control measurements were performed after the 4th week. In order to keep the participants' motivation high throughout the study, an online chat group with the participation of a physician and dietitian, was set up. The study was concluded with 137 patients, because 37 people had left the study by the end of 8 weeks. Total daily energy expenditures were calculated using the Harris-Benedict formula. Participants in the time-restricted eating group were allowed to drink calorie-free soda, unsweetened tea, herbal tea and coffee during their 16-hour fast.
Anthropometric measurements, blood pressure measurements, as well as fasting blood glucose, ALT (alanine aminotransferase), AST (aspartate aminotransferase), lipid panel and HbA1c values in blood samples were checked at the start and the end of the study. Body composition was measured with the bioelectric impedance method with a Tanita Compacto CS 601. The bioelectrical impedance method is prone to error because of fluctuations in body water content. However, it is accepted as a valid method for assessing changes in weight loss studies when duly accompanied by X-ray absorptiometry and reference methods suitable for evaluating multi-compartment body composition under standard conditions [14]. Waist circumference, waist-to-hip ratio and waist-to-height ratio (WHtR), which is recently being recommended, correlate better than BMI in assessing the obesity-related health burden , including total mortality rate, type 2 diabetes, and CVD (cardiovascular disease) risk. The CBC (complete blood count) tests were performed with a Mindrat BC-6800 device, using the SF Cube technology; biochemical tests were performed with a Roche Cobas C702 device that works with photometry; and HbA1c tests were performed with an Arkray HA-8180V device that performs measurements based on the HPLC (High-Performance Liquid Chromatography) technique.
All statistical analyses were performed with the help of SPSS (Statistical Package for the Social Sciences) v. 25.0. The conformity of variables to the normal distribution pattern were checked with histogram graphics and Kolmogorov-Smirnov test. Average, standard deviation, median, IQR (Inter Quantile Range), min.-max. values were used while presenting defining analyses. Categorical variables were compared with Pearson Chi Square Test. Mann Whitney U Test was used in examining the nonparametric variants between groups. The Wilcoxon Test was used for assessing the change in the monitored values within a group, and Repeated Measures Analysis was used for the same purpose when the comparison was being made between the groups. Cases where the P value was under 0.05 were taken as statistically significant results.
- Conditions
- Overweight and Obesity
- Being tested
- 16:8 Time-Restricted Intermittent Fasting Group, Energy-Restricted Six-Meal Group
- Keywords
- Obesity, Nutrition Therapy, Weight Loss, Intermittent Fasting
- Medical subject headings
- Overweight, Obesity, Weight Loss, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16:8 Time-Restricted Intermittent Fasting GroupBehavioural
Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have a feeding window 8 hours and eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). Participants in the time-restricted eating group were allowed to drink calorie-free. They were expected to follow their diet for two months during the study.
Energy-Restricted Six-Meal GroupBehavioural
Participants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have an eating plan three meals and three snacks of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). They were expected to follow their diet for two months during the study.
| Study group | Role | What they receive |
|---|---|---|
| 16:8 Time-Restricted Intermittent Fasting Group | Active comparator | 88 people were included in the 16:8 time-restricted intermittent fasting group with an 8-hour window for food consumption, with an eating plan of 400 kcal lower than the total daily energy requirement. Receives: Behavioral: 16:8 Time-Restricted Intermittent Fasting Group |
| Energy-Restricted Six-Meal Group | Active comparator | 86 people were included in the energy-restricted six-meal group. This group have an eating plan three meal and three snack of 400 kcal lower than the total daily energy requirement. Receives: Behavioral: Energy-Restricted Six-Meal Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight measured in kilogram
It contains weight measured in kilogram. This was measured with Tanita Compacto CS 601 which one 0.1 kg sensitive scale.
Measured: Two months
Secondary outcomes (4)
Body composition
Body composition was measured with the bioelectric impedance method with a Tanita Compacto CS 601. The bioelectrical impedance method is prone to error because of fluctuations in body water content. However, it is accepted as a valid method for assessing changes in weight loss studies when duly accompanied by X-ray absorptiometry and reference methods suitable for evaluating multi-compartment body composition under standard conditions.
Measured: Two months
Body mass index
The BMI is calculated by dividing an adult's weight in kilograms by their height in metres squared. It is expressed in units of kg/m2.
Measured: Two months
Waist-to-height ratio (WHtR)
The waist-height ratio is calculated as waist measurement divided by height measurement, in centimeters.
Measured: Two months
Waist circumference in centimetres
Waist value was measured at the apex of the iliac crest as recommended by the United States National Institutes of Health.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Nov 2021
- Primary completion1 Jul 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein).
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aclan Özder, Bezmialem Vakif University
- Investigators
- Aclan Ozder, Prof, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364475
- Sponsor's protocol ID
- BezmialemVU-TF-AÖ-1
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If they need my data, they can contact me by e-mail.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Time-restricted Eating and Three Meals-three Snacks Diet on Body Composition and on Biochemical Parameters
- ClinicalTrials.gov ID
- NCT06364475
- Acronym / sponsor ID
- BezmialemVU-TF-AÖ-1
- Conditions
- Overweight and Obesity
- Keywords
- Obesity, Nutrition Therapy, Weight Loss, Intermittent Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 15 Apr 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 prevalence of obesity and obesity-related diseases are on the rise worldwide. The widely accepted approach in dietary treatment of obesity is the calorie-restricted three meals-three snacks a day diet; however, alternative approaches are needed. This study was conceived with a view to comparing time-restricted eating, a method which can be easily conveyed and applied in overcoming obesity, to a six meals a day diet. 174 participants aged between 18-65 with a BMI>25 kg/m2 were included. Diet lists with similar calorie, macro counts suitable for their respective group were prepared. Anthropometric measurements, blood pressure, blood tests were analyzed before the study and at the end of the 8-week.
Detailed description
Our study was conducted with participants, aged between 18-65 and with a BMI >25 kg/m2, who consulted a family medicine clinic in Istanbul, accepted the terms and conditions of the study and signed the volunteer consent form. Sample analysis was performed by T.M. with G Power 3.1.9.7 (Franz Faul, Germany), using data from Sundfør et al.'s study, "Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: a randomized 1-year trial". The effect size was assumed to be d: 0.382 for the purposes of calculation. After the calculation made with the aforementioned effect size, with 80% power and 10% margin of error, it was concluded that a cohort of at least 126 samples, of which 63 would be in the patient group and 63 would be in the control group, should be used in this study.
People with a history of bariatric surgery, eating disorders, alcohol and drug addiction, anti-obesity medication use, diagnosed with diabetes and hypothyroidism, active cancer patients and people carrying infectious diseases were excluded from the study. At the beginning of the study, 88 people were included in the 16:8 time-restricted intermittent fasting (time-restricted eating) group, with an eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein); and 86 people were included in the energy-restricted six-meal group. Diet lists suitable for each group were prepared, and food substitution lists were handed out to the participants. Control measurements were performed after the 4th week. In order to keep the participants' motivation high throughout the study, an online chat group with the participation of a physician and dietitian, was set up. The study was concluded with 137 patients, because 37 people had left the study by the end of 8 weeks. Total daily energy expenditures were calculated using the Harris-Benedict formula. Participants in the time-restricted eating group were allowed to drink calorie-free soda, unsweetened tea, herbal tea and coffee during their 16-hour fast.
Anthropometric measurements, blood pressure measurements, as well as fasting blood glucose, ALT (alanine aminotransferase), AST (aspartate aminotransferase), lipid panel and HbA1c values in blood samples were checked at the start and the end of the study. Body composition was measured with the bioelectric impedance method with a Tanita Compacto CS 601. The bioelectrical impedance method is prone to error because of fluctuations in body water content. However, it is accepted as a valid method for assessing changes in weight loss studies when duly accompanied by X-ray absorptiometry and reference methods suitable for evaluating multi-compartment body composition under standard conditions [14]. Waist circumference, waist-to-hip ratio and waist-to-height ratio (WHtR), which is recently being recommended, correlate better than BMI in assessing the obesity-related health burden , including total mortality rate, type 2 diabetes, and CVD (cardiovascular disease) risk. The CBC (complete blood count) tests were performed with a Mindrat BC-6800 device, using the SF Cube technology; biochemical tests were performed with a Roche Cobas C702 device that works with photometry; and HbA1c tests were performed with an Arkray HA-8180V device that performs measurements based on the HPLC (High-Performance Liquid Chromatography) technique.
All statistical analyses were performed with the help of SPSS (Statistical Package for the Social Sciences) v. 25.0. The conformity of variables to the normal distribution pattern were checked with histogram graphics and Kolmogorov-Smirnov test. Average, standard deviation, median, IQR (Inter Quantile Range), min.-max. values were used while presenting defining analyses. Categorical variables were compared with Pearson Chi Square Test. Mann Whitney U Test was used in examining the nonparametric variants between groups. The Wilcoxon Test was used for assessing the change in the monitored values within a group, and Repeated Measures Analysis was used for the same purpose when the comparison was being made between the groups. Cases where the P value was under 0.05 were taken as statistically significant results.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One group 16:8 time-restricted intermittent fasting and the other group energy-restricted six-meal eating. Both of groups with an eating plan suitable with their groups and 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein).
| Arm | Type | Receives |
|---|---|---|
| 16:8 Time-Restricted Intermittent Fasting Group | Active comparator | Behavioral: 16:8 Time-Restricted Intermittent Fasting Group88 people were included in the 16:8 time-restricted intermittent fasting group with an 8-hour window for food consumption, with an eating plan of 400 kcal lower than the total daily energy requirement. |
| Energy-Restricted Six-Meal Group | Active comparator | Behavioral: Energy-Restricted Six-Meal Group86 people were included in the energy-restricted six-meal group. This group have an eating plan three meal and three snack of 400 kcal lower than the total daily energy requirement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 18-65
- BMI >25 kg/m2
Key exclusion criteria (7 listed)
- People with a history of bariatric surgery
- Eating disorders
- Alcohol and drug addiction
- Anti-obesity medication use
- Diagnosed with diabetes and hypothyroidism
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 |
|---|---|---|
| 16:8 Time-Restricted Intermittent Fasting GroupParticipants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have a feeding window 8 hours and eating plan of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). Participants in the time-restricted eating group were allowed to drink calorie-free. They were expected to follow their diet for two months during the study. | Behavioural | 16:8 Time-Restricted Intermittent Fasting Group |
| Energy-Restricted Six-Meal GroupParticipants total daily energy expenditures were calculated using the Harris-Benedict formula. This group have an eating plan three meals and three snacks of 400 kcal lower than the total daily energy requirement and with similar macronutrient content (50% carbohydrates, 25% fat and 25% protein). They were expected to follow their diet for two months during the study. | Behavioural | Energy-Restricted Six-Meal Group |
Primary outcome
Weight measured in kilogram
Time frame: Two months
It contains weight measured in kilogram. This was measured with Tanita Compacto CS 601 which one 0.1 kg sensitive scale.
4 secondary outcomes
Body composition
Time frame: Two months
Body mass index
Time frame: Two months
Waist-to-height ratio (WHtR)
Time frame: Two months
Waist circumference in centimetres
Time frame: Two 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 15 Apr 2024.
- Individual participant dataSharing planned: No. If they need my data, they can contact me by e-mail.
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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.
Aclan Ozder, Prof study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16:8 Time-Restricted Intermittent Fasting Group and Energy-Restricted Six-Meal Group in people with Overweight and Obesity, run by Bezmialem Vakif 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 2 inclusion and 7 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Weight measured in kilogram (time frame: Two months). 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 15 Apr 2024; AzTrials last refreshed its copy on 31 Oct 2026.