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Completed

NCT Number: NCT02417428

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

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 .

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Key information

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universite du Quebec a Montreal

Montreal, Quebec, H2X 1Y4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Citrulline

Dietary 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.

Placebo

Other

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.

Exercise

Behavioral

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 names: High intensity interval training (HIIT)

without exercise

Other

No exercise program will be assigned to participants.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Exploratory aims: improvements in citrate synthase

    Time frame: 12 weeks

    We will determine whether Group A improves citrate synthase (CS),compared to Group C or B or D.

  2. Exploratory aims:improvements in palmitate oxidation.

    Time frame: 12 weeks

    We will determine whether Group A palmitate oxidation, compared to Group C or B or D.

Sponsors and collaborators

Lead sponsor

Université du Québec a Montréal

Other

Collaborators

  • McGill University
  • Université de Montréal

Registry information

Official study title

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

Acronym: CITEX

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 15, 2015
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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