NCT03044444

Brief Summary

In this study, the effect of citrus extract on exercise performance will be investigated. The study consists of three groups: one group will receive a high dose citrus extract, one group will receive a low dose citrus extract and the last group will receive a placebo. After four and eight weeks the effects on performance are measured through a Wingate cycling test. It is expected that exercise performance will increase in the citrus extract groups, compared to the placebo group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

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

January 30, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2018

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

January 30, 2017

Last Update Submit

July 8, 2020

Conditions

Exercise Performance

Keywords

performancepolyphenolsnutritionsports

Outcome Measures

Primary Outcomes (1)

  • peak force output Wingate

    Peak force output in Watts during a high intensity repeated sprint cycling exercise

    8 weeks

Secondary Outcomes (5)

  • jumping height

    8 weeks

  • peak force output Handgrip

    8 weeks

  • force output Jump

    8 weeks

  • anaerobic capacity

    8 weeks

  • running time

    8 weeks

Other Outcomes (1)

  • lactate

    8 weeks

Study Arms (3)

high dose citrus extract

EXPERIMENTAL

this group will receive a high dose (500mg/day) of the citrus extract for 8 weeks

Dietary Supplement: citrus extract

low dose citrus extract

EXPERIMENTAL

this group will receive a low dose (400mg/day) of the citrus extract for 8 weeks

Dietary Supplement: citrus extract

placebo

PLACEBO COMPARATOR

this group will receive a placebo (500mg maltodextrin per day) for 8 weeks

Other: placebo

Interventions

citrus extractDIETARY_SUPPLEMENT

Participants will receive either a low or high dose citrus extract

high dose citrus extractlow dose citrus extract
placeboOTHER

participants will receive 500mg of maltodextrin

placebo

Eligibility Criteria

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

You may qualify if:

  • healthy idividuals
  • Participants are amateur or (semi-) professional athletes in resistance or interval sports (engage in \>4 hours of intense physical activity per week).

You may not qualify if:

  • Use of creatine supplements and/or anabolic steroids.
  • Allergy to test product/placebo
  • Allergy to citrus fruits
  • BMI lower than 18 or higher than 30
  • Recent muscle injury in less than one month before the start of the study.
  • Cardiovascular complications
  • Use of medication that may interfere with the study results
  • Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
  • Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Performance Center

Sittard, Limburg, 6135LG, Netherlands

Location

Related Publications (1)

  • van Iersel LE, Stevens YR, Conchillo JM, Troost FJ. The effect of citrus flavonoid extract supplementation on anaerobic capacity in moderately trained athletes: a randomized controlled trial. J Int Soc Sports Nutr. 2021 Jan 6;18(1):2. doi: 10.1186/s12970-020-00399-w.

    PMID: 33407631DERIVED

MeSH Terms

Interventions

grapefruit seed extract

Study Officials

  • Freddy Troost, Dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 7, 2017

Study Start

April 13, 2017

Primary Completion

April 6, 2018

Study Completion

April 6, 2018

Last Updated

July 10, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)