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CompletedNCT02417428CITEXUpdated Aug 5, 2021

Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)

An interventional study of Citrulline and Placebo in Sarcopenia and Obesity, sponsored by Université du Québec a Montréal. Completed at 1 site in Canada. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-05.

Sponsored by Université du Québec a Montréal · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
60 Years to 100 Years
Sex
All
01

Study summary

The main objective of this study is to determine if oral supplementation of Citrulline, when combined with HIIT, can produce significant changes in body composition, muscle quality, muscle metabolism and functional capacity in older obese men and women .

The investigators hypothesize that Citrulline combined with HIIT will be more beneficial than HIIT alone which will be more beneficial than citrulline alone which will be more beneficial than placebo alone in obese elderly men and women .

Read the detailed description

Citrulline is a non-protein amino acid, isolated from watermelon, involved in the urea cycle and an arginine precursor. Participants will take 10g/d of citrulline or placebo (isocaloric).

High intensity interval training (HIIT) is a high intensity aerobic training (30 sec at 85% and up of HRmax + 1min30 at 65-70% of HRmax). they HIIT duration is 30 min/session. HIIT is recognized as beneficial to improve health in human such as Vo2max, body fat or .

Then intervention will be follow during 12 consecutive weeks.

02

Conditions studied

  • Sarcopenia
  • Obesity

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Keywords

  • Muscle function
  • Functional capacity
03

In context

Sarcopenia

1,206 studies on the registry are indexed under Sarcopenia; 401 are open to participants now.

This study's enrollment of 104 is above the median of 60 across 773 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Université du Québec a Montréal is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. autonomous (being able to follow the exercise program) and without cognitive impairment (MOCA test ≥21) ;
  2. obese status (BMI between 30 and 40 kg / m2 or a waist circumference greater than 102 cm for men and 88 cm for women or fat mass (%; total or androïd or gynoïd) equal or superior to 27% in men and 40% in women;
  3. stable weight (± 5 kg) for 6 months;
  4. non-smoking and moderate drinkers (max: 15 g/day of alcohol) ;
  5. without stroke or history of stroke ;
  6. sedentary (less than 2 hours of structured physical activity per week);
  7. not being involved in a vigorous exercise program for at least 12 months;
  8. can understand French
  9. postmenopausal women (without menses since 60 consecutively months).

Exclusion criteria

Exclusion Criteria:

  1. to have a metal implant (pacemaker);
  2. asthma requiring oral steroid treatment;
  3. taking other medication that could affect metabolism or cardiovascular function;
  4. taking anticoagulant medication.
  5. taking hormonal-replacement therapy (only for women)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
104 participants (actual)

Study arms

  • Experimental
    Citrulline

    Participants that will be randomized in the first arm will be divided in either citrulline plus HIIT (CIT + HIIT or group A) or citrulline alone (CIT or group B).

    Dietary Supplement: Citrulline · Other: without exercise

  • Placebo comparator
    Placebo

    Participants that will be randomized in the second arm will be divided in either placebo plus HIIT (PLA + HIIT or group C) or placebo alone (PLA or group D).

    Other: Placebo · Other: without exercise

  • Experimental
    Exercise

    Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement.

    Dietary Supplement: Citrulline · Behavioral: Exercise

  • Other
    Without exercise

    Participant that will be randomized in this arm will not have an exercise program.

    Other: Placebo · Behavioral: Exercise

Interventions

  • Dietary supplementCitrulline

    Twelve weeks of citrulline oral supplementation will be taken by half of the participants (other are taken a placebo). Citrulline supplementation will be taken orally. Ten grams of citrulline (white powder) will be mixed with a liquid daily. Supplementation will be consumed once at lunch time.

  • OtherPlacebo

    Twelve weeks of oral placebo will be taken by half of the participants. Ten grams of placebo (maltodextrin white powder) will be mixed with a liquid and will be consumed once daily at lunch time.

  • BehavioralExercise

    Participants will also take part in twelve weeks of HIIT (30s at 85% and up of maximal heart rate + 1m30sec at 60-75% of maximal heart rate (HR max). 3 times/ week during 30 continuous minutes. Each period are supervised and monitored using borg scale and polar system.

    Also known as: High intensity interval training (HIIT)

  • Otherwithout exercise

    No exercise program will be assigned to participants.

06

What researchers measure

Primary outcomes

  1. Improvement in body composition and muscle quality

    We will determine whether Group A improves more body composition (decreases fat mass (%), increases Leg lean mass index (kg), increases Leg muscle strength (kg)) than group C, B or D.

    Time frame: 12 weeks

Secondary outcomes

  1. Exploratory aims: improvements in citrate synthase

    We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.

    Time frame: 12 weeks

  2. Exploratory aims:improvements in palmitate oxidation.

    We will determine whether Group A palmitate oxidation, compared to Group C or B or D.

    Time frame: 12 weeks

07

Study locations

1 site
  • Universite du Quebec a Montreal
    Montreal, Quebec H2X 1Y4, Canada
08

References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02417428
Lead sponsor
Université du Québec a Montréal
Collaborators
McGill University, Université de Montréal
Responsible party
Mylène Aubertin-Leheudre (Professor-Researcher, Université du Québec a Montréal) — Principal investigator
First posted
Apr 15, 2015
Start date
Jun 2015
Primary completion
Dec 2017
Completion
Dec 2018
Last update
Aug 5, 2021

Study contacts

Mylene Aubertin-Leheudre, PhD
principal investigator · Université du Québec a Montréal

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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