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

Sponsor
Université du Québec a Montréal (Other)
Overall Status
Completed
CT.gov ID
NCT02417428
Collaborator
McGill University (Other), Université de Montréal (Other)
104
Enrollment
1
Location
4
Arms
42
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Dietary Supplement: Citrulline
  • Other: Placebo
  • Behavioral: Exercise
  • Other: without exercise
 N/A

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 Design

Study Type:
Interventional
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 :
Jun 1, 2015
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

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 Names:
  • High intensity interval training (HIIT)

    		•
    Other: 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 Names:
  • High intensity interval training (HIIT)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement in body composition and muscle quality [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 [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. [12 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 100 Years
    Sexes Eligible for Study:
    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:

    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Universite du Quebec a Montreal Montreal Quebec Canada H2X 1Y4

    Sponsors and Collaborators

    • Université du Québec a Montréal
    • McGill University
    • Université de Montréal

    Investigators

    • Principal Investigator: Mylene Aubertin-Leheudre, PhD, Université du Québec a Montréal

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    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:
    Apr 15, 2015
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Jun 1, 2021
    Keywords provided by Mylène Aubertin-Leheudre, Professor-Researcher, Université du Québec a Montréal
    Muscle function
    Functional capacity
    Additional relevant MeSH terms:
    Sarcopenia

    Study Results

    No Results Posted as of Aug 5, 2021