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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417428
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : May 20, 2019
Sponsor:
Collaborators:
McGill University
Université de Montréal
Information provided by (Responsible Party):
Mylène Aubertin-Leheudre, Université du Québec a Montréal

Tracking Information
First Submitted Date  ICMJE April 2, 2015
First Posted Date  ICMJE April 15, 2015
Last Update Posted Date May 20, 2019
Study Start Date  ICMJE June 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
Improvement in body composition and muscle quality [ Time Frame: 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
Improvement in body composition : fat mass [ Time Frame: 12 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Exploratory aims: improvements in citrate synthase [ Time Frame: 12 weeks ]
    We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.
  • Exploratory aims:improvements in palmitate oxidation. [ Time Frame: 12 weeks ]
    We will determine whether Group A palmitate oxidation, compared to Group C or B or D.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)
Official Title  ICMJE Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women
Brief 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 .

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Sarcopenia
  • Obesity
Intervention  ICMJE
  • Dietary Supplement: Citrulline
    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.
  • Other: Placebo
    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.
  • Behavioral: Exercise
    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.
    Other Name: High intensity interval training (HIIT)
  • Other: without exercise
    No exercise program will be assigned to participants.
Study Arms  ICMJE
  • 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).
    Interventions:
    • 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).
    Interventions:
    • 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.
    Interventions:
    • Dietary Supplement: Citrulline
    • Behavioral: Exercise
  • Without exercise
    Participant that will be randomized in this arm will not have an exercise program.
    Interventions:
    • Other: Placebo
    • Behavioral: Exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2019)
104
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2015)
60
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. autonomous (being able to follow the exercise program) and without cognitive impairment (MOCA test ≥26) ;
  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 % up to 27% in men and up to 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:

  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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02417428
Other Study ID Numbers  ICMJE N/A with our grant
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mylène Aubertin-Leheudre, Université du Québec a Montréal
Study Sponsor  ICMJE Université du Québec a Montréal
Collaborators  ICMJE
  • McGill University
  • Université de Montréal
Investigators  ICMJE
Principal Investigator: Mylene Aubertin-Leheudre, PhD Université du Québec a Montréal
PRS Account Université du Québec a Montréal
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP