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

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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

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 .


Condition or disease Intervention/treatment Phase
Sarcopenia Obesity Dietary Supplement: Citrulline Other: Placebo Behavioral: Exercise Other: without exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women
Study Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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: without exercise
No exercise program will be assigned to participants.

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
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.

Other: without exercise
No exercise program will be assigned to participants.

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
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.

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)

Without exercise
Participant that will be randomized in this arm will not have an exercise program.
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417428


Locations
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Canada, Quebec
Universite du Quebec a Montreal
Montreal, Quebec, Canada, H2X 1Y4
Sponsors and Collaborators
Université du Québec a Montréal
McGill University
Université de Montréal
Investigators
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Principal Investigator: Mylene Aubertin-Leheudre, PhD Université du Québec a Montréal
Publications:

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Responsible Party: Mylène Aubertin-Leheudre, Professor-Researcher, Université du Québec a Montréal
ClinicalTrials.gov Identifier: NCT02417428    
Other Study ID Numbers: N/A with our grant
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Keywords provided by Mylène Aubertin-Leheudre, Université du Québec a Montréal:
Muscle function
Functional capacity
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical