NCT05350566

Brief Summary

The main objective of this study is to determine the effectiveness of a nutritional intervention (olive leaf extract) combined with a specific training session (MICT or SIT) on PDH activation (as well as other protein expressions) and exercise-induced muscle fatigue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

April 14, 2022

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • PDH dephosphorylation

    protein involved in skeletal muscle metabolism

    before, immediately after and 24 hours after exercise completion

  • expression of OXPHOS proteins

    proteins used as markers of oxidative phosphorylation complexes

    before, immediately after and 24 hours after exercise completion

  • expression of MCU protein

    protein involved in the transport of Ca2+ in the mitochondria

    before, immediately after and 24 hours after exercise completion

Secondary Outcomes (4)

  • Maximal voluntary contraction force

    before, immediately after and 24 hours after exercise completion

  • Voluntary activation level

    before, immediately after and 24 hours after exercise completion

  • Peak doublet evoked at 100 Hz

    before, immediately after and 24 hours after exercise completion

  • M-wave amplitude

    before, immediately after and 24 hours after exercise completion

Study Arms (2)

Sprint interval training group (SIT group)

EXPERIMENTAL

The model of sprint interval training (SIT) consists of six 30 s all-out cycling bouts on a cycle ergometer, with 4 min rests between tests.

Dietary Supplement: Olive leaf extractDietary Supplement: Placebo

Moderate intensity continuous training (MICT group)

EXPERIMENTAL

The moderate intensity continuous training (MICT) consists of 1h cycling on a cycle ergometer at 50% of the maximal aerobic power output

Dietary Supplement: Olive leaf extractDietary Supplement: Placebo

Interventions

Olive leaf extractDIETARY_SUPPLEMENT

A capsule containing 250 mg of an olive leaf extract preparation will be swallowed with a glass of water before exercise.

Moderate intensity continuous training (MICT group)Sprint interval training group (SIT group)
PlaceboDIETARY_SUPPLEMENT

A capsule containing 336 mg of cellulose microcrystalline will be swallowed with a glass of water before exercise.

Moderate intensity continuous training (MICT group)Sprint interval training group (SIT group)

Eligibility Criteria

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

You may qualify if:

  • Being male (including females would necessitate increasing the number of included participants to consider sex as a variable which would burden the project too much).
  • Being aged between 18 and 40 years
  • Being healthy (The assessment will be done through a questionnaire and an interview/examination by a medical doctor if there is any doubts)
  • Being physically active, but not involved in any structured training program
  • Having stable dietary habits

You may not qualify if:

  • Having previous medical events that would put the participant at risk during the study
  • Ingesting caffeine on the experimental days
  • Not being currently treated for blood clotting problems
  • Taking aspirin or anti-coagulant drugs in the 48 hours preceding the experimental days in which muscle samples will be collected
  • Having allergy to xylocaine
  • Having food allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bâtiment Synathlon, quartier UNIL-Centre

Lausanne, 1015, Switzerland

Location

Related Publications (2)

  • Place N, Ivarsson N, Venckunas T, Neyroud D, Brazaitis M, Cheng AJ, Ochala J, Kamandulis S, Girard S, Volungevicius G, Pauzas H, Mekideche A, Kayser B, Martinez-Redondo V, Ruas JL, Bruton J, Truffert A, Lanner JT, Skurvydas A, Westerblad H. Ryanodine receptor fragmentation and sarcoplasmic reticulum Ca2+ leak after one session of high-intensity interval exercise. Proc Natl Acad Sci U S A. 2015 Dec 15;112(50):15492-7. doi: 10.1073/pnas.1507176112. Epub 2015 Nov 2.

    PMID: 26575622BACKGROUND
  • Zanou N, Dridi H, Reiken S, Imamura de Lima T, Donnelly C, De Marchi U, Ferrini M, Vidal J, Sittenfeld L, Feige JN, Garcia-Roves PM, Lopez-Mejia IC, Marks AR, Auwerx J, Kayser B, Place N. Acute RyR1 Ca2+ leak enhances NADH-linked mitochondrial respiratory capacity. Nat Commun. 2021 Dec 10;12(1):7219. doi: 10.1038/s41467-021-27422-1.

    PMID: 34893614BACKGROUND

MeSH Terms

Interventions

olive leaf extract

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
One box containing the product and one containing the placebo will be labeled A or B. The code will be kept in a sealed envelope which will be revealed only at the end of the study or in case of an adverse event.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The design is a placebo-controlled, double blind, cross-over two-arm study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 28, 2022

Study Start

June 7, 2022

Primary Completion

December 7, 2022

Study Completion

December 7, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations