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

Not Applicable

Completed

• Conditions: Sarcopenia; Obesity
• Interventions: Dietary Supplement: Citrulline; Other: Placebo; Other: without exercise; Behavioral: Exercise

• Registration Number: NCT02417428
• Lead Sponsor: 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 .

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 Timeline

• Study First Submitted: 2015-04-02
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Study Start: 2015-06
• Primary Completion: 2017-12
• Study Completion: 2018-12
• Status Verified: 2021-06
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Citrulline	Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement.
Placebo	without exercise	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).
Citrulline	without exercise	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).
Citrulline	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).
Placebo	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).
Exercise	Exercise	Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement.
Without exercise	Placebo	Participant that will be randomized in this arm will not have an exercise program.
Without exercise	Exercise	Participant that will be randomized in this arm will not have an exercise program.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Exploratory aims:improvements in palmitate oxidation.	12 weeks	We will determine whether Group A palmitate oxidation, compared to Group C or B or D.

Trial Locations

Locations (1)

Universite du Quebec a Montreal; 🇨🇦 Montreal, Quebec, Canada