NCT07015008

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 23, 2025

Last Update Submit

June 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximal Fat Oxidation Rate

    g/min using a metabolic chart

    Through study completion, an average of 4 weeks

Secondary Outcomes (2)

  • Fat mass

    Through study completion, an average of 4 weeks

  • Fat-free mass

    Through study completion, an average of 4 weeks

Study Arms (4)

8h Sleep (at home)

PLACEBO COMPARATOR

Arm Description: Participants sleep 8h at home

Behavioral: Sleep deprivationBehavioral: Sleep place

8h Sleep (Laboratory)

EXPERIMENTAL

Participants sleep 8h in the lab

Behavioral: Sleep deprivationBehavioral: Sleep place

4h Sleep (Laboratory)

EXPERIMENTAL

Participants sleep 4h in the laboratory

Behavioral: Sleep deprivation

0h Sleep (Laboratory)

EXPERIMENTAL

Participants sleep 0h in the laboratory

Behavioral: Sleep deprivation

Interventions

Partial (4h) or total (0h) sleep deprivation

0h Sleep (Laboratory)4h Sleep (Laboratory)8h Sleep (Laboratory)8h Sleep (at home)
Sleep placeBEHAVIORAL

8h sleep at home or in the laboratory

8h Sleep (Laboratory)8h Sleep (at home)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Facultad de Medicina y Ciencias de la Salud. Universidad de Alcalá

Alcalá de Henares, Madrid, Spain

Location

MeSH Terms

Conditions

Sleep Deprivation

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Statistician
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 11, 2025

Study Start

January 1, 2025

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Locations