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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women

Conditions
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Sarcopenia, Obesity

Intervention / Treatment
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* Dietary Supplement: Citrulline
* Other: Placebo
* Behavioral: Exercise
* Other: without exercise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Citrulline<br>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<br>* 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.<br>Other: without exercise<br>* No exercise program will be assigned to participants.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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.<br>Other: without exercise<br>* No exercise program will be assigned to participants.<br>|
| Experimental: Exercise<br>Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement. | Dietary Supplement: Citrulline<br>* 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.<br>Behavioral: Exercise<br>* 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.<br>* Other names: High intensity interval training (HIIT);|
| Other: Without exercise<br>Participant that will be randomized in this arm will not have an exercise program. | Other: Placebo<br>* 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.<br>Behavioral: Exercise<br>* 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.<br>* Other names: High intensity interval training (HIIT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory aims: improvements in citrate synthase | We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D. | 12 weeks | 
| Exploratory aims:improvements in palmitate oxidation. | We will determine whether Group A palmitate oxidation, compared to Group C or B or D. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Muscle function, Functional capacity