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

NCT02417428 | Completed

• 1 other identifier: N/A with our grant
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Sarcopenia; Obesity

Keywords

Muscle function; Functional capacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Exploratory aims: improvements in citrate synthase

  12 weeks

• Exploratory aims:improvements in palmitate oxidation.

  12 weeks

Study Arms (4)

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).

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).

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.

Dietary Supplement: Citrulline; Behavioral: Exercise

Without exercise

OTHER

Participant that will be randomized in this arm will not have an exercise program.

Other: Placebo; Behavioral: Exercise

Interventions

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.

Citrulline; Exercise

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.

Placebo; Without exercise

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.

Also known as: High intensity interval training (HIIT)

Exercise; Without exercise

without exercise OTHER

No exercise program will be assigned to participants.

Citrulline; Placebo

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université du Québec a Montréal: lead
• McGill University: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Universite du Quebec a Montreal

Montreal, Quebec, H2X 1Y4, Canada

Location

Related Publications (76)

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MeSH Terms

Conditions

Sarcopenia; Obesity

Interventions

Citrulline; Exercise; High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Intervention Hierarchy (Ancestors)

Amino Acids, Diamino; Amino Acids; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human

Study Officials

• Mylene Aubertin-Leheudre, PhD

  Université du Québec a Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor-Researcher

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 15, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 5, 2021

Record last verified: 2021-06

Locations

CA (1)