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

Obesity Clinical Trial

— CITEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417428
• Other study ID #: N/A with our grant
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2018

Study information

• Verified date: June 2021
• Source: Université du Québec a Montréal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
Canada	Universite du Quebec a Montreal	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Université du Québec a Montréal	McGill University, Université de Montréal

Country where clinical trial is conducted

Canada, 

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* Note: There are 76 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Exploratory aims:improvements in palmitate oxidation.	We will determine whether Group A palmitate oxidation, compared to Group C or B or D.	12 weeks