FastingNCT04668378
Effects of a Time Restricted Eating Protocol on Resistance Training Men
A study testing Time restricted eating and Normal Diet in people with Fasting and Healthy, run by University of Padova at 1 site in Italy.
Trial summary
The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- What is being tested?
- Time restricted eating and Normal Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2014to 31 Aug 2017
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- continuously engaged in resistance training for at least 5 years
- at least 3 years experience in split training routines
- male
Who cannot join
- adherence to special diets
- use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
- use of steroids
- use of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Time-restricted Eating and Resistance Training on Body Composition, Inflammatory Markers and Cardiometabolic Risk Factors
The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males
Read the detailed description
Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem) and 8:00 PM. During the experimental period, training loads were similar and standardize in the two groups. partecipants were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured. After the completition of the first two months of study, subjects were ask to volunteer to continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each group (TRE or ND) continued and completed the second part of the study.
- Being tested
- Time restricted eating, Normal Diet
- Keywords
- fasting, time restricted eating, resistance training, body composition, inflammation
- Medical subject headings
- Fasting, 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
TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.
Normal DietOther
ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating (TRE) - two month | Experimental | partecipants underwent 2 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. Receives: Other: Time restricted eating |
| Normal Diet (ND) - two month | Active comparator | partecipants underwent 2 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. Receives: Other: Normal Diet |
| Time restricted eating (TRE) - twelve month | Experimental | partecipants underwent 12 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. Receives: Other: Time restricted eating |
| Normal Diet (ND) - twelve month | Active comparator | partecipants underwent 12 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. Receives: Other: Normal Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Mass
fat mass measured dual energy X-ray absorptiometry (DXA)
Measured: change from baseline to up to 2 months
Fat Free Mass
fat free mass measured dual energy X-ray absorptiometry (DXA)
Measured: change from baseline to up to 2 months
Secondary outcomes (8)
Fat Mass
fat mass measured dual energy X-ray absorptiometry (DXA)
Measured: change from baseline to up to 12 months
Fat Free Mass
fat free mass measured dual energy X-ray absorptiometry (DXA)
Measured: change from baseline to up to 12 months
total cholesterol
total cholesterol as milligram per deciliter
Measured: change from baseline to up to 2 months
total cholesterol
total cholesterol as milligram per deciliter
Measured: change from baseline to up to 12 months
glucose
glucose as milligram per deciliter
Measured: change from baseline to up to 2 months
glucose
glucose as milligram per deciliter
Measured: change from baseline to up to 12 months
Leg muscle strength
Leg muscle strength measured via via 1-RM test
Measured: change from baseline to up to 2 months
Leg muscle strength
Leg muscle strength measured via via 1-RM test
Measured: change from baseline to up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start1 Jan 2014
- Primary completion31 Mar 2015
- Study completion31 Aug 2017
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 FastingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a single blind, parallel arms study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Paoli, University of Padova
- Investigators
- Antonio Paoli, MD, Principal investigator, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668378
- Sponsor's protocol ID
- TRE-RET
- Status last verified
- Dec 2020
- First submitted
- 4 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moro T, Tinsley G, Pacelli FQ, Marcolin G, Bianco A, Paoli A. Twelve Months of Time-restricted Eating and Resistance Training Improves Inflammatory Markers and Cardiometabolic Risk Factors. Med Sci Sports Exerc. 2021 Dec 1;53(12):2577-2585. doi: 10.1249/MSS.0000000000002738.
PubMed 34649266
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-restricted Eating and Resistance Training on Body Composition, Inflammatory Markers and Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT04668378
- Acronym / sponsor ID
- TRE-RET
- Keywords
- fasting, time restricted eating, resistance training, body composition, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Mar 2015 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 16 Dec 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.
The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males
Detailed description
Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem) and 8:00 PM. During the experimental period, training loads were similar and standardize in the two groups. partecipants were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured. After the completition of the first two months of study, subjects were ask to volunteer to continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each group (TRE or ND) continued and completed the second part of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- It is a single blind, parallel arms study
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating (TRE) - two month | Experimental | Other: Time restricted eatingpartecipants underwent 2 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. |
| Normal Diet (ND) - two month | Active comparator | Other: Normal Dietpartecipants underwent 2 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. |
| Time restricted eating (TRE) - twelve month | Experimental | Other: Time restricted eatingpartecipants underwent 12 months of a TRE protocol, during which they consumed 100% of the daily energy needs in an 8-hour time window: from 1:00 PM to 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. |
| Normal Diet (ND) - twelve month | Active comparator | Other: Normal Dietpartecipants underwent 12 months of a regular diet schedule and consumed 100% of the daily energy needs in 3 meals between 8:00 AM and 8:00 PM. Body composition, muscle strength and blood parameters were measured before and after the diet intervention. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- continuously engaged in resistance training for at least 5 years
- at least 3 years experience in split training routines
- male
Key exclusion criteria (4 listed)
- adherence to special diets
- use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement)
- use of steroids
- use of medications
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 eatingTRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period. | Other | Time restricted eating (TRE) - twelve month, Time restricted eating (TRE) - two month |
| Normal DietND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m. | Other | Normal Diet (ND) - twelve month, Normal Diet (ND) - two month |
Primary outcome
Fat Mass
Time frame: change from baseline to up to 2 months
fat mass measured dual energy X-ray absorptiometry (DXA)
Fat Free Mass
Time frame: change from baseline to up to 2 months
fat free mass measured dual energy X-ray absorptiometry (DXA)
8 secondary outcomes
Fat Mass
Time frame: change from baseline to up to 12 months
Fat Free Mass
Time frame: change from baseline to up to 12 months
total cholesterol
Time frame: change from baseline to up to 2 months
total cholesterol
Time frame: change from baseline to up to 12 months
glucose
Time frame: change from baseline to up to 2 months
glucose
Time frame: change from baseline to up to 12 months
Leg muscle strength
Time frame: change from baseline to up to 2 months
Leg muscle strength
Time frame: change from baseline to up to 12 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 17 Dec 2020.
- Derived from this study: PubMed 34649266Moro T, Tinsley G, Pacelli FQ, Marcolin G, Bianco A, Paoli A. Twelve Months of Time-restricted Eating and Resistance Training Improves Inflammatory Markers and Cardiometabolic Risk Factors. Med Sci Sports Exerc. 2021 Dec 1;53(12):2577-2585. doi: 10.1249/MSS.0000000000002738.
- 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.
Antonio Paoli, MD 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 and Normal Diet in people with Fasting and Healthy, 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 3 inclusion and 4 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 17 Dec 2020. 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?
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?
Fat Mass (time frame: change from baseline to up to 2 months). The study lists 2 primary outcomes in all. 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 NCT04668378, 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 17 Dec 2020.