NCT05880186

Brief Summary

Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in women. The aim of this study was to evaluate the influence of the time of the day on the effect of caffeine on maximal rate of fat oxidation during aerobic exercise in women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

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

February 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 18, 2023

Last Update Submit

May 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • MFO

    Maximal fat oxidation during exercise

    2-months

Secondary Outcomes (3)

  • FATmax

    2-months

  • RPE

    2-months

  • FAT AND CHO oxidation

    2-months

Study Arms (2)

Caffeine intake

EXPERIMENTAL

Test in the morning A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test. Test in the evening A dose of 3 mg/kg of caffeine (Bulk Powders, Essex, United Kingdom) was ingested before the beginning of each test.

Dietary Supplement: Acute caffeine supplementation

Placebo intake

PLACEBO COMPARATOR

Test in the morning A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test. Test in the evening A dose of 3 mg/kg of placebo (Cellulose, Guinama, Valencia, Spain) was ingested before the beginning of each test

Dietary Supplement: Acute caffeine supplementation

Interventions

To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women.

Caffeine intakePlacebo intake

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be non-smokers.
  • To have low caffeine intake (i.e., \< 50 mg of caffeine per day in the previous 2 months)
  • To show no previous history of cardiopulmonary diseases or having suffered musculoskeletal injuries in the previous 6 months.
  • To have a regular duration of their menstrual cycle for the previous 6 months.
  • To confirm no existence of any type of menstrual disorders such as dysmenorrhea, amenorrhea, or strong symptoms associated with pre-menstrual syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Related Publications (1)

  • Munoz A, Aguilar-Navarro M, Ruiz-Moreno C, Varillas-Delgado D, Amaro-Gahete FJ, Gutierrez-Hellin J, Del Coso J, Lopez-Samanes A. Influence of the time of day in the effect of caffeine on maximal fat oxidation during exercise in women: a randomized, crossover, double-blind, and placebo-controlled study. Eur J Appl Physiol. 2024 Mar;124(3):849-859. doi: 10.1007/s00421-023-05312-2. Epub 2023 Sep 20.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Dietary Supplement: caffeine acute supplementation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

February 9, 2021

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

May 30, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations