Sleep DeprivationSleep&FatNCT07015008
Sleep and Maximal Fat Oxidation
A study testing Sleep deprivation and Sleep place in people with Sleep Deprivation, run by University of Alcala at 1 site in Spain.
Trial summary
Introduction: Despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Deprivation
- What is being tested?
- Sleep deprivation and Sleep place
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 30 Apr 2025
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 35 years.
- Body Mass Index (BMI) \< 25 kg/m².
- Resistance-trained individuals (more than 2 years of structured training).
- Healthy men and women without neurological, cardiometabolic, immunological, or physical conditions that prevent them from exercising.
- Participants must be able to perform the tests described in the following section.
Who cannot join
- History of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism.
- Use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study.
- Sedentary habits (less than 150 minutes/week of moderate exercise).
- Having undergone prolonged periods of physical inactivity in the 6 months prior to the study.
- Engaging in strenuous exercise within 48 hours prior to the tests.
- Failure to replicate the same food intake on both experimental days.
- Consumption of caffeine or any other stimulant the day before the tests.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá
Alcalá de Henares, Madrid
About this study
Official title: Relationship Between Sleep Time and Maximal Fat Oxidation Capacity During Exercise.
Introduction: Despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. Furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear.
Objectives: The aim of this study is to evaluate the effects of sleep deprivation on maximal fat oxidation (MFO) in male and female participants.
- Conditions
- Sleep Deprivation
- Being tested
- Sleep deprivation, Sleep place
- Medical subject headings
- Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep deprivationBehavioural
Partial (4h) or total (0h) sleep deprivation
Sleep placeBehavioural
8h sleep at home or in the laboratory
| Study group | Role | What they receive |
|---|---|---|
| 8h Sleep (at home) | Placebo comparator | Arm Description: Participants sleep 8h at home Receives: Behavioral: Sleep deprivation; Behavioral: Sleep place |
| 8h Sleep (Laboratory) | Experimental | Participants sleep 8h in the lab Receives: Behavioral: Sleep deprivation; Behavioral: Sleep place |
| 4h Sleep (Laboratory) | Experimental | Participants sleep 4h in the laboratory Receives: Behavioral: Sleep deprivation |
| 0h Sleep (Laboratory) | Experimental | Participants sleep 0h in the laboratory Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Fat Oxidation Rate
g/min using a metabolic chart
Measured: Through study completion, an average of 4 weeks
Secondary outcomes (2)
Fat mass
Using electrical bioimpedance (kg of body mass)
Measured: Through study completion, an average of 4 weeks
Fat-free mass
Using electrical bioimpedance (kg of body mass)
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jan 2025
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
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 Sleep DeprivationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Pérez-López, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015008
- Sponsor's protocol ID
- CEID/2023/6/119_2
- Acronym
- Sleep&Fat
- Status last verified
- Jun 2025
- First submitted
- 23 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Del Val-Manzano M, Montalvo-Alonso JJ, Gonzalo-Encabo P, Valades D, Ferragut C, Perez-Lopez A. Acute Sleep Deprivation Shifts Substrate Utilization Toward Greater Fat Oxidation During Incremental Exercise in Recreationally Trained Adults. Scand J Med Sci Sports. 2026 Jun;36(6):e70314. doi: 10.1111/sms.70314.
PubMed 42223297
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sleep Time and Maximal Fat Oxidation Capacity During Exercise.
- ClinicalTrials.gov ID
- NCT07015008
- Acronym / sponsor ID
- Sleep&Fat / CEID/2023/6/119_2
- Conditions
- Sleep Deprivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Jun 2025 (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.
Introduction: Despite the awareness of the importance of sleep in our lives, especially for athletes, the consequences of poor rest on sports performance are not well understood. Furthermore, the interaction between complete and partial sleep deprivation over one night and sleeping the usual hours for each person remains unclear.
Objectives: The aim of this study is to evaluate the effects of sleep deprivation on maximal fat oxidation (MFO) in male and female participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 8h Sleep (at home) | Placebo comparator | Behavioral: Sleep deprivation, Behavioral: Sleep placeArm Description: Participants sleep 8h at home |
| 8h Sleep (Laboratory) | Experimental | Behavioral: Sleep deprivation, Behavioral: Sleep placeParticipants sleep 8h in the lab |
| 4h Sleep (Laboratory) | Experimental | Behavioral: Sleep deprivationParticipants sleep 4h in the laboratory |
| 0h Sleep (Laboratory) | Experimental | Behavioral: Sleep deprivationParticipants sleep 0h in the laboratory |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
Key exclusion criteria (7 listed)
- History of neuromuscular diseases, heart disease, or conditions that may affect liver or muscle metabolism.
- Use of drugs, stimulants, or sports supplements that could interfere with the dietary supplement used in the study.
- Sedentary habits (less than 150 minutes/week of moderate exercise).
- Having undergone prolonged periods of physical inactivity in the 6 months prior to the study.
- Engaging in strenuous exercise within 48 hours prior to the tests.
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 |
|---|---|---|
| Sleep deprivationPartial (4h) or total (0h) sleep deprivation | Behavioural | 0h Sleep (Laboratory), 4h Sleep (Laboratory), 8h Sleep (Laboratory), 8h Sleep (at home) |
| Sleep place8h sleep at home or in the laboratory | Behavioural | 8h Sleep (Laboratory), 8h Sleep (at home) |
Primary outcome
Maximal Fat Oxidation Rate
Time frame: Through study completion, an average of 4 weeks
g/min using a metabolic chart
2 secondary outcomes
Fat mass
Time frame: Through study completion, an average of 4 weeks
Fat-free mass
Time frame: Through study completion, an average of 4 weeks
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 11 Jun 2025.
- Derived from this study: PubMed 42223297Del Val-Manzano M, Montalvo-Alonso JJ, Gonzalo-Encabo P, Valades D, Ferragut C, Perez-Lopez A. Acute Sleep Deprivation Shifts Substrate Utilization Toward Greater Fat Oxidation During Incremental Exercise in Recreationally Trained Adults. Scand J Med Sci Sports. 2026 Jun;36(6):e70314. doi: 10.1111/sms.70314.
- Individual participant dataSharing planned: Yes
Related trials for Sleep Deprivation
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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 Sleep deprivation and Sleep place in people with Sleep Deprivation, run by University of Alcala at 1 site in Spain.
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 5 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 11 Jun 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Maximal Fat Oxidation Rate (time frame: Through study completion, an average of 4 weeks). 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 NCT07015008, 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 11 Jun 2025.