Time Restricted FeedingTRENCT05730231
Clinical Trials of Effects of Time Restricted Eating on Health Parameters in Adults
A study testing Effects of calorie restriction and time-restricted eating on human health in people with Time Restricted Feeding and Overweight and Obesity, run by University of Primorska at 1 site in Slovenia.
Trial summary
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Time Restricted Feeding, Overweight and Obesity, Inflammation
- What is being tested?
- Effects of calorie restriction and time-restricted eating on human health
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSlovenia
- Study dates
- 3 Mar 2023to 30 Jun 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-35 kg/m2
- + one of the following criteria:
- Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- Fasting plasma glucose > 5,6 mmol/L
- Elevated fasting plasma triglycerides 1,7 mmol/l
- Reduced high-density lipoprotein (HDL)-cholesterol < 1,0 mmol/l for men, < 1,3 mmol/l for women
Show all 9Show fewer
- Elevated blood pressure, systolic blood pressure > 130 mm Hg and diastolic blood pressure > 85 mm Hg
- Without medicals for hypertension and hypercholesterolemia
- Morning or afternoon working time
Who cannot join
- Pregnant or plan to be become pregnant
- Lactating women
- Active smoking
- Diagnosis of diabetes
- Eating disorders
- Currently enrolled in a weight-management program
Show all 10Show fewer
- Uncontrolled medical condition due to gastrointestinal, psychiatric, rheumatologic, oncologic, hematologic or endocrine diseases
- History of tumor
- History of serious cardiovascular or cerebrovascular diseases
- Taking medicines that may affect weight and appetite
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences
Izola, 6310
About this study
Official title: Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.
Read the detailed description
Obesity has become one of the world's most common diseases and is a major global public health challenge. Obesity contributes to an increased risk of developing various chronic diseases, such as diabetes, metabolic syndrome, hypertension, cardiovascular and kidney diseases and many others. Reducing excess body weight and improving eating habits decreases risk of disease and mortality. A lot of dietary strategies for weight loss are known and most of them are based on daily calorie restriction. Recently, an increasingly popular dietary strategy has been "time restricted eating (TRE)". In this strategy, all calorie intake is restricted within a consistent interval of less than 12 hours (4 - 10 hours). Eating window is limited to early part of the day - early TRE or mid-day TRE. Research shows that TRE has a number of beneficial effect on individuals, including weight loss, improvement of insulin sensitivity, hypercholesterolaemia, circadian rhythm of hormone secretion and other. Which TRE (early or mid-day TRE) has better health effects is still being investigated. It is also not clear how the timing, number and composition of individual meals affect on the health indicators, mentioned previously.
Therefore, the aim of our study is to evaluate and compare the effects of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters in adults with at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, anthropometry, inflammation status, glucose levels), antioxidative status, hormones (leptin, ghrelin, cortisol, insulin, adiponectin, cholecystokinin, melatonin, BDNF, IGF-1) will be measured. In addition changes in gene expression of different proteins will be examined. Moreover, stool samples will be also taken at baseline and after three months of intervention.
- Conditions
- Time Restricted Feeding, Overweight and Obesity, Inflammation, Hypercholesterolemia, Hypertension, Hyperglycemia
- Being tested
- Effects of calorie restriction and time-restricted eating on human health
- Keywords
- time-restricted eating, calorie restriction, metabolic syndrome, overweight and obesity, dietary strategy
- Medical subject headings
- Intermittent Fasting, Overweight, Obesity, Inflammation, Hypercholesterolemia, Hypertension, Hyperglycemia, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of calorie restriction and time-restricted eating on human healthOther
Calorie restriction plan will be prepared for each participant. After nutritional data collection at baseline, all participant will attend educational sessions about healthy diet and beneficial effects of time-restricted eating. To estimate total energy needs, individuals' RMR will be measured from indirect calorimeter and multiplied by the appropriate factor of physical activity (from 1.3 to 1.6), and then a reduction of 200-500 kcal will be made. Macronutrient composition of the diet will be approximately 45-55% of carbohydrate, 30-35% of fat, and 15-20% of protein. 30% of daily energy intake will be consumed by breakfast, 40% by lunch and 30% by dinner. During posting participants will be allowed to consume only water and herbal infusions without added sugars or sweeteners. Dietary intake of participants will be followed during the study using a 24-h recall. Dietary data will be analysed using the Open Platform for Clinical Nutrition accessible through the website http://opkp.si/.
| Study group | Role | What they receive |
|---|---|---|
| Early time-restricted eating with calorie restriction | Experimental | Participants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM. Receives: Other: Effects of calorie restriction and time-restricted eating on human health |
| Mid-day time-restricted eating with calorie restriction | Experimental | Participants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM. Receives: Other: Effects of calorie restriction and time-restricted eating on human health |
| Daily calorie restriction | Experimental | Participants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM. Receives: Other: Effects of calorie restriction and time-restricted eating on human health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: three months
Secondary outcomes (11)
Change in Body Fat
Changes in percentage of body fat from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: three months
Changes in Visceral Fat Rating
Changes in visceral fat rating (index) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA. The range of the visceral fat rating (scale) is from 0 to 30. Higher scores indicate excess visceral fat (a worse outcome).
Measured: three months
Changes in Muscle mass
Changes in muscle mass (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
Measured: three months
LDL Cholesterol
Changes in LDL cholesterol measured by biochemical analyzer Cobass
Measured: three months
Inflammation
Changes in C-reactive protein levels measured by biochemical analyzer Cobass
Measured: three months
Glucose levels
Changes in glucose levels measured by biochemical analyzer Cobass
Measured: three months
Resting metabolic rate
Changes in resting metabolic rate measured by (MedGem® Microlife, Medical Home Solutions, Inc., Golden, CO)
Measured: three months
ultrasound scan of abdomen
ultrasound scan of abdomen measured by Resona 7 Mindray
Measured: three months
ultrasound scan of carotid arteries
ultrasound scan of carotid arteries measured by Resona 7 Mindray
Measured: three months
Antioxidative potential
Antioxidative potential will be determined with DPPH radical measurement.
Measured: three months
Blood Pressure
Changes in systolic blood pressure measured by blood pressure device (Omron M3)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start3 Mar 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Time Restricted FeedingStudies 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
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zala Jenko Praznikar, University of Primorska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730231
- Sponsor's protocol ID
- TRE_Clinical
- Acronym
- TRE
- Status last verified
- Aug 2024
- First submitted
- 6 Feb 2023
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manoogian ENC, Chow LS, Taub PR, Laferrere B, Panda S. Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Endocr Rev. 2022 Mar 9;43(2):405-436. doi: 10.1210/endrev/bnab027.
PubMed 34550357Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.
PubMed 35443107Swiatkiewicz I, Mila-Kierzenkowska C, Wozniak A, Szewczyk-Golec K, Nuszkiewicz J, Wroblewska J, Rajewski P, Eussen SJPM, Faerch K, Manoogian ENC, Panda S, Taub PR. Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. Nutrients. 2021 Jan 24;13(2):346. doi: 10.3390/nu13020346.
PubMed 33498955Zhang LM, Liu Z, Wang JQ, Li RQ, Ren JY, Gao X, Lv SS, Liang LY, Zhang F, Yin BW, Sun Y, Tian H, Zhu HC, Zhou YT, Ma YX. Randomized controlled trial for time-restricted eating in overweight and obese young adults. iScience. 2022 Aug 5;25(9):104870. doi: 10.1016/j.isci.2022.104870. eCollection 2022 Sep 16.
PubMed 36034217Habe B, Cresnovar T, Petelin A, Kenig S, Mohorko N, Jenko Praznikar Z. Comparing the influence of early and late time-restricted eating with energy restriction and energy restriction alone on cardiometabolic markers, metabolic hormones and appetite in adults with overweight/obesity: per-protocol analysis of a 3-month randomized clinical trial. Nutr Metab (Lond). 2025 Jul 29;22(1):85. doi: 10.1186/s12986-025-00984-3.
PubMed 40731289Cresnovar T, Habe B, Mohorko N, Kenig S, Jenko Praznikar Z, Petelin A. Early time-restricted eating with energy restriction has a better effect on body fat mass, diastolic blood pressure, metabolic age and fasting glucose compared to late time-restricted eating with energy restriction and/or energy restriction alone: A 3-month randomized clinical trial. Clin Nutr. 2025 Jun;49:57-68. doi: 10.1016/j.clnu.2025.04.001. Epub 2025 Apr 8.
PubMed 40250088
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Calorie Restriction With Early Time-restricted Eating and Calorie Restriction With Mid-day Time-restricted Eating and Daily Calorie Restriction
- ClinicalTrials.gov ID
- NCT05730231
- Acronym / sponsor ID
- TRE / TRE_Clinical
- Conditions
- Time Restricted Feeding, Overweight and Obesity, Inflammation, Hypercholesterolemia, Hypertension, Hyperglycemia
- Keywords
- time-restricted eating, calorie restriction, metabolic syndrome, overweight and obesity, dietary strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Feb 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.
In a randomized controlled trial we will research the effect of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters. Participants will be divided into three groups: early time-restriction group (8:00 AM to 4:00 PM), mid-day restriction group (1:00 PM to 9:00 PM) and daily calorie restriction group (8:00 AM to 9:00 PM). Participants will follow dietary strategy with three planned meals and calorie restriction. Anthropometrical and biochemical parameters will be measured at baseline, after one month, two months and at after three months of intervention. Resting metabolic rate, ultrasound scan of abdomen and ultrasound scan of carotid arteries will be measured at baseline and after three months of intervention. In addition, stool samples will be also taken at baseline and after three months of intervention.
Detailed description
Obesity has become one of the world's most common diseases and is a major global public health challenge. Obesity contributes to an increased risk of developing various chronic diseases, such as diabetes, metabolic syndrome, hypertension, cardiovascular and kidney diseases and many others. Reducing excess body weight and improving eating habits decreases risk of disease and mortality. A lot of dietary strategies for weight loss are known and most of them are based on daily calorie restriction. Recently, an increasingly popular dietary strategy has been "time restricted eating (TRE)". In this strategy, all calorie intake is restricted within a consistent interval of less than 12 hours (4 - 10 hours). Eating window is limited to early part of the day - early TRE or mid-day TRE. Research shows that TRE has a number of beneficial effect on individuals, including weight loss, improvement of insulin sensitivity, hypercholesterolaemia, circadian rhythm of hormone secretion and other. Which TRE (early or mid-day TRE) has better health effects is still being investigated. It is also not clear how the timing, number and composition of individual meals affect on the health indicators, mentioned previously.
Therefore, the aim of our study is to evaluate and compare the effects of calorie restriction with early and mid-day time-restricted eating (TRE) and daily calorie restriction on weight loss and human health parameters in adults with at least two components of metabolic syndrome and yet not receiving any medication. The components of metabolic syndrome (lipid profile, blood pressure, anthropometry, inflammation status, glucose levels), antioxidative status, hormones (leptin, ghrelin, cortisol, insulin, adiponectin, cholecystokinin, melatonin, BDNF, IGF-1) will be measured. In addition changes in gene expression of different proteins will be examined. Moreover, stool samples will be also taken at baseline and after three months of intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early time-restricted eating with calorie restriction | Experimental | Other: Effects of calorie restriction and time-restricted eating on human healthParticipants will follow calorie restriction with early day time-restricted eating protocol with three planned meals from 8:00 AM to 4:00 PM. |
| Mid-day time-restricted eating with calorie restriction | Experimental | Other: Effects of calorie restriction and time-restricted eating on human healthParticipants will follow calorie restriction with mid-day time-restricted eating protocol with three planned meals from 1:00 PM to 9:00 PM. |
| Daily calorie restriction | Experimental | Other: Effects of calorie restriction and time-restricted eating on human healthParticipants will follow daily calorie restriction protocol with three planned meals from 8:00 AM to 9:00 PM. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- BMI 25-35 kg/m2
- Increased waist circumference ≥ 94 cm in men and ≥ 80 cm in women
- Fasting plasma glucose > 5,6 mmol/L
- Elevated fasting plasma triglycerides 1,7 mmol/l
- Reduced high-density lipoprotein (HDL)-cholesterol < 1,0 mmol/l for men, < 1,3 mmol/l for women
Key exclusion criteria (10 listed)
- Pregnant or plan to be become pregnant
- Lactating women
- Active smoking
- Diagnosis of diabetes
- Eating disorders
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 |
|---|---|---|
| Effects of calorie restriction and time-restricted eating on human healthCalorie restriction plan will be prepared for each participant. After nutritional data collection at baseline, all participant will attend educational sessions about healthy diet and beneficial effects of time-restricted eating. To estimate total energy needs, individuals' RMR will be measured from indirect calorimeter and multiplied by the appropriate factor of physical activity (from 1.3 to 1.6), and then a reduction of 200-500 kcal will be made. Macronutrient composition of the diet will be approximately 45-55% of carbohydrate, 30-35% of fat, and 15-20% of protein. 30% of daily energy intake will be consumed by breakfast, 40% by lunch and 30% by dinner. During posting participants will be allowed to consume only water and herbal infusions without added sugars or sweeteners. Dietary intake of participants will be followed during the study using a 24-h recall. Dietary data will be analysed using the Open Platform for Clinical Nutrition accessible through the website http://opkp.si/. | Other | Daily calorie restriction, Early time-restricted eating with calorie restriction, Mid-day time-restricted eating with calorie restriction |
Primary outcome
Change in Body Weight
Time frame: three months
Changes in body weight (in kilograms) from baseline to week twelve measured with bioelectrical impedance analysis (BIA) Tanita MC-980MA
11 secondary outcomes
Change in Body Fat
Time frame: three months
Changes in Visceral Fat Rating
Time frame: three months
Changes in Muscle mass
Time frame: three months
LDL Cholesterol
Time frame: three months
Inflammation
Time frame: three months
Glucose levels
Time frame: three months
Resting metabolic rate
Time frame: three months
ultrasound scan of abdomen
Time frame: three months
ultrasound scan of carotid arteries
Time frame: three months
Antioxidative potential
Time frame: three months
Blood Pressure
Time frame: three 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 5 Mar 2025.
- Background: PubMed 34550357Manoogian ENC, Chow LS, Taub PR, Laferrere B, Panda S. Time-restricted Eating for the Prevention and Management of Metabolic Diseases. Endocr Rev. 2022 Mar 9;43(2):405-436. doi: 10.1210/endrev/bnab027.
- Background: PubMed 35443107Liu D, Huang Y, Huang C, Yang S, Wei X, Zhang P, Guo D, Lin J, Xu B, Li C, He H, He J, Liu S, Shi L, Xue Y, Zhang H. Calorie Restriction with or without Time-Restricted Eating in Weight Loss. N Engl J Med. 2022 Apr 21;386(16):1495-1504. doi: 10.1056/NEJMoa2114833.
- Background: PubMed 33498955Swiatkiewicz I, Mila-Kierzenkowska C, Wozniak A, Szewczyk-Golec K, Nuszkiewicz J, Wroblewska J, Rajewski P, Eussen SJPM, Faerch K, Manoogian ENC, Panda S, Taub PR. Pilot Clinical Trial of Time-Restricted Eating in Patients with Metabolic Syndrome. Nutrients. 2021 Jan 24;13(2):346. doi: 10.3390/nu13020346.
- Background: PubMed 36034217Zhang LM, Liu Z, Wang JQ, Li RQ, Ren JY, Gao X, Lv SS, Liang LY, Zhang F, Yin BW, Sun Y, Tian H, Zhu HC, Zhou YT, Ma YX. Randomized controlled trial for time-restricted eating in overweight and obese young adults. iScience. 2022 Aug 5;25(9):104870. doi: 10.1016/j.isci.2022.104870. eCollection 2022 Sep 16.
- Derived from this study: PubMed 40731289Habe B, Cresnovar T, Petelin A, Kenig S, Mohorko N, Jenko Praznikar Z. Comparing the influence of early and late time-restricted eating with energy restriction and energy restriction alone on cardiometabolic markers, metabolic hormones and appetite in adults with overweight/obesity: per-protocol analysis of a 3-month randomized clinical trial. Nutr Metab (Lond). 2025 Jul 29;22(1):85. doi: 10.1186/s12986-025-00984-3.
- Derived from this study: PubMed 40250088Cresnovar T, Habe B, Mohorko N, Kenig S, Jenko Praznikar Z, Petelin A. Early time-restricted eating with energy restriction has a better effect on body fat mass, diastolic blood pressure, metabolic age and fasting glucose compared to late time-restricted eating with energy restriction and/or energy restriction alone: A 3-month randomized clinical trial. Clin Nutr. 2025 Jun;49:57-68. doi: 10.1016/j.clnu.2025.04.001. Epub 2025 Apr 8.
- Individual participant dataSharing planned: Undecided
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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 Effects of calorie restriction and time-restricted eating on human health in people with Time Restricted Feeding and Overweight and Obesity, run by University of Primorska at 1 site in Slovenia.
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 9 inclusion and 10 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 5 Mar 2025. 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 Slovenia. 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 (time frame: three months). 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 NCT05730231, which also lists 6 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 5 Mar 2025.