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

Primary Purpose

Sarcopenia, Obesity

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Citrulline
Placebo
Exercise
without exercise
Sponsored by
Université du Québec a Montréal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Muscle function, Functional capacity

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Universite du Quebec a Montreal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Other

Arm Label

Citrulline

Placebo

Exercise

Without exercise

Arm Description

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).

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).

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Exploratory aims: improvements in citrate synthase
We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.
Exploratory aims:improvements in palmitate oxidation.
We will determine whether Group A palmitate oxidation, compared to Group C or B or D.

Full Information

First Posted
April 2, 2015
Last Updated
August 3, 2021
Sponsor
Université du Québec a Montréal
Collaborators
McGill University, Université de Montréal
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1. Study Identification

Unique Protocol Identification Number
NCT02417428
Brief Title
Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)
Acronym
CITEX
Official Title
Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec a Montréal
Collaborators
McGill University, Université de Montréal

4. Oversight

Data Monitoring Committee
No

5. 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 .
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Obesity
Keywords
Muscle function, Functional capacity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citrulline
Arm Type
Experimental
Arm Description
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).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement.
Arm Title
Without exercise
Arm Type
Other
Arm Description
Participant that will be randomized in this arm will not have an exercise program.
Intervention Type
Dietary Supplement
Intervention Name(s)
Citrulline
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
High intensity interval training (HIIT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
without exercise
Intervention Description
No exercise program will be assigned to participants.
Primary Outcome Measure Information:
Title
Improvement in body composition and muscle quality
Description
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 Outcome Measure Information:
Title
Exploratory aims: improvements in citrate synthase
Description
We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.
Time Frame
12 weeks
Title
Exploratory aims:improvements in palmitate oxidation.
Description
We will determine whether Group A palmitate oxidation, compared to Group C or B or D.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: autonomous (being able to follow the exercise program) and without cognitive impairment (MOCA test ≥21) ; 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; stable weight (± 5 kg) for 6 months; non-smoking and moderate drinkers (max: 15 g/day of alcohol) ; without stroke or history of stroke ; sedentary (less than 2 hours of structured physical activity per week); not being involved in a vigorous exercise program for at least 12 months; can understand French postmenopausal women (without menses since 60 consecutively months). Exclusion Criteria: to have a metal implant (pacemaker); asthma requiring oral steroid treatment; taking other medication that could affect metabolism or cardiovascular function; taking anticoagulant medication. taking hormonal-replacement therapy (only for women)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mylene Aubertin-Leheudre, PhD
Organizational Affiliation
Université du Québec a Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universite du Quebec a Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1Y4
Country
Canada

12. IPD Sharing Statement

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

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