SarcopeniaCITEXNCT02417428
Citrulline Supplementation Combined With Exercise: Effect on Muscle Function in Elderly People (CITEX Study)
A study testing Citrulline, Exercise and without exercise in people with Sarcopenia and Obesity, run by Université du Québec a Montréal at 1 site in Canada.
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 . Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Obesity
- What is being tested?
- Citrulline, Exercise and without exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Show all 9Show fewer
- not being involved in a vigorous exercise program for at least 12 months;
- can understand French
- postmenopausal women (without menses since 60 consecutively months).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women
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 .
Read the 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.
- Conditions
- Sarcopenia, Obesity
- Being tested
- Citrulline, Placebo, Exercise, without exercise
- Keywords
- Muscle function, Functional capacity
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitrullineDietary supplement
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.
PlaceboOther
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.
ExerciseBehavioural
Also called High intensity interval training (HIIT)
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.
without exerciseOther
No exercise program will be assigned to participants.
| Study group | Role | What they receive |
|---|---|---|
| Citrulline | Experimental | 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). Receives: Dietary Supplement: Citrulline; Other: without exercise |
| Placebo | Placebo comparator | 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). Receives: Other: Placebo; Other: without exercise |
| Exercise | Experimental | Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement. Receives: Dietary Supplement: Citrulline; Behavioral: Exercise |
| Without exercise | Other | Participant that will be randomized in this arm will not have an exercise program. Receives: Other: Placebo; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Exploratory aims: improvements in citrate synthase
We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.
Measured: 12 weeks
Exploratory aims:improvements in palmitate oxidation.
We will determine whether Group A palmitate oxidation, compared to Group C or B or D.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (76)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec a Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Université de Montréal
- Responsible party
- Principal investigator, Mylène Aubertin-Leheudre, Université du Québec a Montréal
- Investigators
- Mylene Aubertin-Leheudre, PhD, Principal investigator, Université du Québec a Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417428
- Sponsor's protocol ID
- N/A with our grant
- Acronym
- CITEX
- Status last verified
- Jun 2021
- First submitted
- 2 Apr 2015
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Figueroa A, Alvarez-Alvarado S, Ormsbee MJ, Madzima TA, Campbell JC, Wong A. Impact of L-citrulline supplementation and whole-body vibration training on arterial stiffness and leg muscle function in obese postmenopausal women with high blood pressure. Exp Gerontol. 2015 Mar;63:35-40. doi: 10.1016/j.exger.2015.01.046. Epub 2015 Jan 28.
PubMed 25636814Moinard C, Nicolis I, Neveux N, Darquy S, Benazeth S, Cynober L. Dose-ranging effects of citrulline administration on plasma amino acids and hormonal patterns in healthy subjects: the Citrudose pharmacokinetic study. Br J Nutr. 2008 Apr;99(4):855-62. doi: 10.1017/S0007114507841110. Epub 2007 Oct 22.
PubMed 17953788Bahri S, Zerrouk N, Aussel C, Moinard C, Crenn P, Curis E, Chaumeil JC, Cynober L, Sfar S. Citrulline: from metabolism to therapeutic use. Nutrition. 2013 Mar;29(3):479-84. doi: 10.1016/j.nut.2012.07.002. Epub 2012 Sep 28.
PubMed 23022123Batsis JA, Mackenzie TA, Barre LK, Lopez-Jimenez F, Bartels SJ. Sarcopenia, sarcopenic obesity and mortality in older adults: results from the National Health and Nutrition Examination Survey III. Eur J Clin Nutr. 2014 Sep;68(9):1001-7. doi: 10.1038/ejcn.2014.117. Epub 2014 Jun 25.
PubMed 24961545Blaum CS, Xue QL, Michelon E, Semba RD, Fried LP. The association between obesity and the frailty syndrome in older women: the Women's Health and Aging Studies. J Am Geriatr Soc. 2005 Jun;53(6):927-34. doi: 10.1111/j.1532-5415.2005.53300.x.
PubMed 15935013Baumgartner RN. Body composition in healthy aging. Ann N Y Acad Sci. 2000 May;904:437-48. doi: 10.1111/j.1749-6632.2000.tb06498.x.
PubMed 10865787Cesari M, Pahor M, Lauretani F, Zamboni V, Bandinelli S, Bernabei R, Guralnik JM, Ferrucci L. Skeletal muscle and mortality results from the InCHIANTI Study. J Gerontol A Biol Sci Med Sci. 2009 Mar;64(3):377-84. doi: 10.1093/gerona/gln031. Epub 2009 Jan 30.
PubMed 19181709Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
PubMed 12028177Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.
PubMed 18395429Prado CM, Wells JC, Smith SR, Stephan BC, Siervo M. Sarcopenic obesity: A Critical appraisal of the current evidence. Clin Nutr. 2012 Oct;31(5):583-601. doi: 10.1016/j.clnu.2012.06.010. Epub 2012 Jul 17.
PubMed 22809635Lu Y, Shu H, Zheng Y, Li C, Liu M, Chen Z, He X. Comparison of fat-free mass index and fat mass index in Chinese adults. Eur J Clin Nutr. 2012 Sep;66(9):1004-7. doi: 10.1038/ejcn.2012.86. Epub 2012 Jul 18.
PubMed 22805496Baumgartner RN, Wayne SJ, Waters DL, Janssen I, Gallagher D, Morley JE. Sarcopenic obesity predicts instrumental activities of daily living disability in the elderly. Obes Res. 2004 Dec;12(12):1995-2004. doi: 10.1038/oby.2004.250.
PubMed 15687401Rolland Y, Lauwers-Cances V, Cristini C, Abellan van Kan G, Janssen I, Morley JE, Vellas B. Difficulties with physical function associated with obesity, sarcopenia, and sarcopenic-obesity in community-dwelling elderly women: the EPIDOS (EPIDemiologie de l'OSteoporose) Study. Am J Clin Nutr. 2009 Jun;89(6):1895-900. doi: 10.3945/ajcn.2008.26950. Epub 2009 Apr 15.
PubMed 19369381Vilaca KH, Carneiro JA, Ferriolli E, Lima NK, de Paula FJ, Moriguti JC. Body composition, physical performance and muscle quality of active elderly women. Arch Gerontol Geriatr. 2014 Jul-Aug;59(1):44-8. doi: 10.1016/j.archger.2014.02.004. Epub 2014 Feb 22.
PubMed 24630334Zoico E, Di Francesco V, Guralnik JM, Mazzali G, Bortolani A, Guariento S, Sergi G, Bosello O, Zamboni M. Physical disability and muscular strength in relation to obesity and different body composition indexes in a sample of healthy elderly women. Int J Obes Relat Metab Disord. 2004 Feb;28(2):234-41. doi: 10.1038/sj.ijo.0802552.
PubMed 14708033
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Citrulline Supplementation Combined With Exercise on Muscle Function and Functional Capacity in Older Obese Men and Women
- ClinicalTrials.gov ID
- NCT02417428
- Acronym / sponsor ID
- CITEX / N/A with our grant
- Conditions
- Sarcopenia, Obesity
- Keywords
- Muscle function, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Université du Québec a MontréalUniversity, hospital or other
- Collaborators
- McGill University, Université de Montréal
- Study start
- Jun 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Citrulline | Experimental | Dietary Supplement: Citrulline, Other: without exerciseParticipants 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 comparator | Other: Placebo, Other: without exerciseParticipants 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 | Experimental | Dietary Supplement: Citrulline, Behavioral: ExerciseParticipant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement. |
| Without exercise | Other | Other: Placebo, Behavioral: ExerciseParticipant that will be randomized in this arm will not have an exercise program. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 ;
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CitrullineTwelve 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. | Dietary supplement | Citrulline, Exercise |
| PlaceboTwelve 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 | Placebo, Without exercise |
| ExerciseAlso: High intensity interval training (HIIT)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. | Behavioural | Exercise, Without exercise |
| without exerciseNo exercise program will be assigned to participants. | Other | Citrulline, Placebo |
Primary outcome
Improvement in body composition and muscle quality
Time frame: 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.
2 secondary outcomes
Exploratory aims: improvements in citrate synthase
Time frame: 12 weeks
Exploratory aims:improvements in palmitate oxidation.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 25636814Figueroa A, Alvarez-Alvarado S, Ormsbee MJ, Madzima TA, Campbell JC, Wong A. Impact of L-citrulline supplementation and whole-body vibration training on arterial stiffness and leg muscle function in obese postmenopausal women with high blood pressure. Exp Gerontol. 2015 Mar;63:35-40. doi: 10.1016/j.exger.2015.01.046. Epub 2015 Jan 28.
- Background: PubMed 17953788Moinard C, Nicolis I, Neveux N, Darquy S, Benazeth S, Cynober L. Dose-ranging effects of citrulline administration on plasma amino acids and hormonal patterns in healthy subjects: the Citrudose pharmacokinetic study. Br J Nutr. 2008 Apr;99(4):855-62. doi: 10.1017/S0007114507841110. Epub 2007 Oct 22.
- Background: PubMed 23022123Bahri S, Zerrouk N, Aussel C, Moinard C, Crenn P, Curis E, Chaumeil JC, Cynober L, Sfar S. Citrulline: from metabolism to therapeutic use. Nutrition. 2013 Mar;29(3):479-84. doi: 10.1016/j.nut.2012.07.002. Epub 2012 Sep 28.
- Background: PubMed 24961545Batsis JA, Mackenzie TA, Barre LK, Lopez-Jimenez F, Bartels SJ. Sarcopenia, sarcopenic obesity and mortality in older adults: results from the National Health and Nutrition Examination Survey III. Eur J Clin Nutr. 2014 Sep;68(9):1001-7. doi: 10.1038/ejcn.2014.117. Epub 2014 Jun 25.
- Background: PubMed 15935013Blaum CS, Xue QL, Michelon E, Semba RD, Fried LP. The association between obesity and the frailty syndrome in older women: the Women's Health and Aging Studies. J Am Geriatr Soc. 2005 Jun;53(6):927-34. doi: 10.1111/j.1532-5415.2005.53300.x.
- Background: PubMed 10865787Baumgartner RN. Body composition in healthy aging. Ann N Y Acad Sci. 2000 May;904:437-48. doi: 10.1111/j.1749-6632.2000.tb06498.x.
- Background: PubMed 19181709Cesari M, Pahor M, Lauretani F, Zamboni V, Bandinelli S, Bernabei R, Guralnik JM, Ferrucci L. Skeletal muscle and mortality results from the InCHIANTI Study. J Gerontol A Biol Sci Med Sci. 2009 Mar;64(3):377-84. doi: 10.1093/gerona/gln031. Epub 2009 Jan 30.
- Background: PubMed 12028177Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
- Background: PubMed 18395429Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.
- Background: PubMed 22809635Prado CM, Wells JC, Smith SR, Stephan BC, Siervo M. Sarcopenic obesity: A Critical appraisal of the current evidence. Clin Nutr. 2012 Oct;31(5):583-601. doi: 10.1016/j.clnu.2012.06.010. Epub 2012 Jul 17.
- Background: PubMed 22805496Lu Y, Shu H, Zheng Y, Li C, Liu M, Chen Z, He X. Comparison of fat-free mass index and fat mass index in Chinese adults. Eur J Clin Nutr. 2012 Sep;66(9):1004-7. doi: 10.1038/ejcn.2012.86. Epub 2012 Jul 18.
- Background: PubMed 15687401Baumgartner RN, Wayne SJ, Waters DL, Janssen I, Gallagher D, Morley JE. Sarcopenic obesity predicts instrumental activities of daily living disability in the elderly. Obes Res. 2004 Dec;12(12):1995-2004. doi: 10.1038/oby.2004.250.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mylene Aubertin-Leheudre, PhD principal investigator
Université du Québec a Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrulline, Exercise and without exercise in people with Sarcopenia and Obesity, run by Université du Québec a Montréal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in body composition and muscle quality (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417428, which also lists 76 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.