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

August 3, 2021 updated by: Mylène Aubertin-Leheudre, Université du Québec a Montréal

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 1Y4
        • Université du Québec a Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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).
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: without exercise
No exercise program will be assigned to participants.
PLACEBO_COMPARATOR: 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).
Other: without exercise
No exercise program will be assigned to participants.
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.
EXPERIMENTAL: Exercise
Participant that will be randomized in this arm will have an exercise program (HIIT) added to their respective dietary supplement.
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.
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 Names:
  • High intensity interval training (HIIT)
OTHER: Without exercise
Participant that will be randomized in this arm will not have an exercise program.
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 Names:
  • High intensity interval training (HIIT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université du Québec a Montréal

Collaborators

McGill University
Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

April 2, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (ESTIMATE)

April 15, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N/A with our grant

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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