Energy ExpenditureTRENCT05890391
The Effect of Time-Restricted Eating on Nutritional Status
A study testing Time-Restricted Eating and Energy-Restricted Diet in people with Energy Expenditure and Anthropometric Measure, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to investigate the effect of TRE on the nutritional status and diet quality of individuals and to compare the effects of TRE and energy-restricted diet (ERD) in healthy overweight individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Energy Expenditure, Anthropometric Measure, Blood Pressure
- What is being tested?
- Time-Restricted Eating and Energy-Restricted Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 30 May 2021
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent form was signed by the individuals who accepted the study.
Who cannot join
- Individuals who smoke, who are pregnant, lactating and who are in the postmenopausal period, who take hormone therapy, who have followed any diet program for the last 3 months before the study, and who use vitamin/mineral supplementation were not included in the study.
- Individuals who wanted to increase their physical activity level in addition to the applied diet were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time-Restricted Eating (16/8) and Energy-Restricted Diet: Effects on Diet Quality, Body Composition and Biochemical Parameters in Healthy Overweight Females
This study was planned to investigate the effect of TRE on the nutritional status and diet quality of individuals and to compare the effects of TRE and energy-restricted diet (ERD) in healthy overweight individuals. The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list. Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m.No restrictions were imposed on the type and amount of food consumed during the feeding period. During the fasting period, individuals consumed water and non-energy drinks (tea, coffee, soda, etc.). Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail. Anthropometric and body composition measurements of individuals were taken. The energy expenditure was measured using indirect calorimetry. Blood pressure and heart rate measurements were made. Biochemical parameters were evaluated and food consumption were taken. The quality of dietary intake was assessed using the Healthy Eating Index (HEI) -2015.
Read the detailed description
The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list.
Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m. No restrictions were imposed on the type and amount of food consumed during the feeding period.
Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail.
Parameters to be evaluated at the beginning and end of the study
Anthropometric and body composition measurements The energy expenditure Blood pressure and heart rate measurements Biochemical parameters Food consumption The quality of dietary intake
- Conditions
- Energy Expenditure, Anthropometric Measure, Blood Pressure, Biochemical Markers, Healthy Eating Index
- Being tested
- Time-Restricted Eating, Energy-Restricted Diet
- Keywords
- time-restricted eating, diet quality, body composition, biochemical parameters
- Medical subject headings
- Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted EatingOther
They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m.
Energy-Restricted DietOther
The total energy expenditure (TEE) of individuals was determined using the 'Resting Energy Expenditure (REE) x Physical Activity Level (PAL) ' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating | Experimental | Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks. Receives: Other: Time-Restricted Eating |
| Energy-Restricted Diet | Experimental | Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. Receives: Other: Energy-Restricted Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight in kilograms
Body weight measurement were taken using an Inbody 720 body analyzer.
Measured: 8 weeks
The energy expenditure in kcal
Resting energy expenditure was measured at the beginning and end of the study using indirect calorimetry (COSMED, FitMatePro, Rome, Italy). Measurements were taken in the early morning hours after at least 8 hours of fasting.
Measured: 8 weeks
Blood cholesterol level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
The quality of dietary intake
Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).
Measured: 8 weeks
Height in meters
The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.
Measured: 8 weeks
waist circumference in meters
For waist circumference measurement, the midpoint between the lowest rib bone and the cristailiac was found, and the circumference measurement passing through this point was taken.
Measured: 8 weeks
Blood Triglyceride level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood fasting glucose level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood insulin level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood C-reactive protein level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood leptin level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood adiponectin level
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood total antioxidant status
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Blood total oxidant status
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Measured: 8 weeks
Physical Activity Level (PAL)
Physical Activity Level (PAL) was determined by physical activity record.
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 posted6 Jun 2023
- Study start1 Jan 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Model description
- The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özge Mengi Çelik, Saglik Bilimleri Universitesi
- Investigators
- ÖZGE MENGİ ÇELİK, Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890391
- Sponsor's protocol ID
- 86/2019
- Acronym
- TRE
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating (16/8) and Energy-Restricted Diet: Effects on Diet Quality, Body Composition and Biochemical Parameters in Healthy Overweight Females
- ClinicalTrials.gov ID
- NCT05890391
- Acronym / sponsor ID
- TRE / 86/2019
- Conditions
- Energy Expenditure, Anthropometric Measure, Blood Pressure, Biochemical Markers, Healthy Eating Index
- Keywords
- time-restricted eating, diet quality, body composition, biochemical parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 6 Jun 2023 (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.
This study was planned to investigate the effect of TRE on the nutritional status and diet quality of individuals and to compare the effects of TRE and energy-restricted diet (ERD) in healthy overweight individuals. The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list. Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m.No restrictions were imposed on the type and amount of food consumed during the feeding period. During the fasting period, individuals consumed water and non-energy drinks (tea, coffee, soda, etc.). Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail. Anthropometric and body composition measurements of individuals were taken. The energy expenditure was measured using indirect calorimetry. Blood pressure and heart rate measurements were made. Biochemical parameters were evaluated and food consumption were taken. The quality of dietary intake was assessed using the Healthy Eating Index (HEI) -2015.
Detailed description
The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list.
Individuals in the TRE group applied a diet limited to 8 hours for 8 weeks (16/8). They were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m. No restrictions were imposed on the type and amount of food consumed during the feeding period.
Individuals in the ERD group followed a diet specially prepared for them for 8 weeks. At the first encounter with individuals, resting energy expenditure (REE) was measured by the indirect calorimetry method. Physical Activity Level (PAL) was determined by physical activity record. The total energy expenditure (TEE) of individuals was determined using the 'REE x PAL' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. Individuals were not given a diet containing energy below the REE. Acceptable macronutrient distribution range (AMDR) were taken as dietary content. The diet given to individuals has 45-65% carbohydrate, 20-35% fat, 10-35% protein content. Nutritional habits of individuals were taken into consideration while planning the diet. Each individual consumed 3 main meals and the number of snacks was determined individually. Food exchange lists were given to individuals and nutrient changes were explained in detail.
Parameters to be evaluated at the beginning and end of the study
Anthropometric and body composition measurements The energy expenditure Blood pressure and heart rate measurements Biochemical parameters Food consumption The quality of dietary intake
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The female individuals were randomly divided into the TRE or ERD groups in an unbiased manner using a computer-generated block randomisation list.
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating | Experimental | Other: Time-Restricted EatingIndividuals in the TRE group applied a diet limited to 8 hours for 8 weeks. |
| Energy-Restricted Diet | Experimental | Other: Energy-Restricted DietIndividuals in the ERD group followed a diet specially prepared for them for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consent form was signed by the individuals who accepted the study.
Key exclusion criteria (2 listed)
- Individuals who smoke, who are pregnant, lactating and who are in the postmenopausal period, who take hormone therapy, who have followed any diet program for the last 3 months before the study, and who use vitamin/mineral supplementation were not included in the study.
- Individuals who wanted to increase their physical activity level in addition to the applied diet were not included in the study.
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 |
|---|---|---|
| Time-Restricted EatingThey were fed ad libitum between 10.00 a.m-06.00 p.m and fasted between 06.00 p.m-10.00 a.m. | Other | Time-Restricted Eating |
| Energy-Restricted DietThe total energy expenditure (TEE) of individuals was determined using the 'Resting Energy Expenditure (REE) x Physical Activity Level (PAL) ' formulation. 'TEE-500 kcal' formulation was used for the diet to be given to individuals. | Other | Energy-Restricted Diet |
Primary outcome
Body weight in kilograms
Time frame: 8 weeks
Body weight measurement were taken using an Inbody 720 body analyzer.
The energy expenditure in kcal
Time frame: 8 weeks
Resting energy expenditure was measured at the beginning and end of the study using indirect calorimetry (COSMED, FitMatePro, Rome, Italy). Measurements were taken in the early morning hours after at least 8 hours of fasting.
Blood cholesterol level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
The quality of dietary intake
Time frame: 8 weeks
Diet quality was assessed with the Healthy Eating Index-2015 (HEI-2015).
Height in meters
Time frame: 8 weeks
The height of the individuals was measured with a stadiometer with a sensitivity of 0.1 cm.
waist circumference in meters
Time frame: 8 weeks
For waist circumference measurement, the midpoint between the lowest rib bone and the cristailiac was found, and the circumference measurement passing through this point was taken.
Blood Triglyceride level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood fasting glucose level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood insulin level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood C-reactive protein level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood leptin level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood adiponectin level
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood total antioxidant status
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Blood total oxidant status
Time frame: 8 weeks
The measurement was analyzed after at least 8 hours of fasting in the morning hours at the beginning and end of the study.
Physical Activity Level (PAL)
Time frame: 8 weeks
Physical Activity Level (PAL) was determined by physical activity record.
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 Jun 2023.
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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.
ÖZGE MENGİ ÇELİK principal investigator
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Restricted Eating and Energy-Restricted Diet in people with Energy Expenditure and Anthropometric Measure, run by Saglik Bilimleri Universitesi 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 2 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 Jun 2023. 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?
Body weight in kilograms (time frame: 8 weeks). The study lists 15 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 6 Jun 2023.