Healthy DietFaTE-TRENCT04503005
Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)
A study testing Time Restricted Eating in people with Healthy Diet and Fasting, Intermittent, run by University of Padova at 1 site in Italy.
Trial summary
Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet, Fasting, Intermittent
- What is being tested?
- Time Restricted Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 8 Mar 2021to 31 Aug 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI between 18-30 kg/m2
- Stable body weight for at least 3 months
Who cannot join
- type 2 Diabetes or pre-diabetes for ADA guidelines
- Significant Chronic disease
- recent and acute inflammatory status
- Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.
- regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Nutrition and Exercise Lab, DSB, University of Padova
Padova, 35131
Tatiana Moro, PhD, 0498275306, tatiana.moro@unipd.it
About this study
Official title: Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol
Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes.
Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods.
Read more
Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG).
The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.
- Conditions
- Healthy Diet, Fasting, Intermittent
- Being tested
- Time Restricted Eating
- Keywords
- time restricted eating, intermitted fasting, body composition, metabolism, inflammation
- Medical subject headings
- Intermittent Fasting, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingOther
Effect of 16, 14 or 12 hours of daily fasting
| Study group | Role | What they receive |
|---|---|---|
| Effect of fasting duration | Active comparator | study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults. Receives: Other: Time Restricted Eating |
| Effect of time restricted eating protocol on chronotype | Other | study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults. Receives: Other: Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
change of body fat percentage measured via DEXA
Measured: 2 months
Secondary outcomes (3)
Blood cholesterol (total, HDL, LDL)
Change in blood lipid profile
Measured: 2 months
Blood cytokines (IL-6; IL-1, TNF-a)
Change in blood inflammatory markers
Measured: 2 months
Morningness-Eveningness Questionnaire (MEQ) on chronotype
effect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start8 Mar 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy DietStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Tatiana Moro, Ph.D, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503005
- Sponsor's protocol ID
- FaTE-TRE
- Acronym
- FaTE-TRE
- Status last verified
- Apr 2021
- First submitted
- 30 Jul 2020
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Sampieri A, Paoli A, Spinello G, Santinello E, Moro T. Impact of daily fasting duration on body composition and cardiometabolic risk factors during a time-restricted eating protocol: a randomized controlled trial. J Transl Med. 2024 Nov 29;22(1):1086. doi: 10.1186/s12967-024-05849-6.
PubMed 39614235
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol
- ClinicalTrials.gov ID
- NCT04503005
- Acronym / sponsor ID
- FaTE-TRE / FaTE-TRE
- Conditions
- Healthy Diet, Fasting, Intermittent
- Keywords
- time restricted eating, intermitted fasting, body composition, metabolism, inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 6 Aug 2020 (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.
Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes.
Recently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods.
Time-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG).
The literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of fasting duration | Active comparator | Other: Time Restricted Eatingstudy the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults. |
| Effect of time restricted eating protocol on chronotype | Other | Other: Time Restricted Eatingstudy the effect of 2 month of time restricted eating on the chronotype profile of healthy adults. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI between 18-30 kg/m2
- Stable body weight for at least 3 months
Key exclusion criteria (5 listed)
- type 2 Diabetes or pre-diabetes for ADA guidelines
- Significant Chronic disease
- recent and acute inflammatory status
- Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.
- regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day
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 EatingEffect of 16, 14 or 12 hours of daily fasting | Other | Effect of fasting duration, Effect of time restricted eating protocol on chronotype |
Primary outcome
Body composition
Time frame: 2 months
change of body fat percentage measured via DEXA
3 secondary outcomes
Blood cholesterol (total, HDL, LDL)
Time frame: 2 months
Blood cytokines (IL-6; IL-1, TNF-a)
Time frame: 2 months
Morningness-Eveningness Questionnaire (MEQ) on chronotype
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 39614235Sampieri A, Paoli A, Spinello G, Santinello E, Moro T. Impact of daily fasting duration on body composition and cardiometabolic risk factors during a time-restricted eating protocol: a randomized controlled trial. J Transl Med. 2024 Nov 29;22(1):1086. doi: 10.1186/s12967-024-05849-6.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Tatiana Moro, Ph.D principal investigator
University of Padova
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 in people with Healthy Diet and Fasting, Intermittent, run by University of Padova at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Moro, Ph.D (0498275306, tatiana.moro@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 2 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 NCT04503005, which also lists 1 linked publication.
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 26 Apr 2021.