Clinical trial NCT04345237: Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine
Official title: Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Person
Body Composition
Physical Exercise
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 142
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Controlled clinical trial, randomized by strata (sex and period of the study), with 6 parallel branches to the study depending on the type of product consumed and the type of physical exercise program performed, double-blind masked for the consumption of the product and single-center.

Detailed description: The subjects that meet the selection criteria will make a total of seven visits to the research laboratory (two of them to collect product) and will carry out the pre-established tests in the protocol. Subsequently, a statistical analysis will be carried out with the variables measured in the study to obtain results.

Eligibility criteria: Inclusion Criteria:

* Subjects of both sexes with age between 55-70 years.
* Body mass index less than 35.
* Subjects who have given written informed consent to participate in the study.

Exclusion Criteria:

* Consumption during the 6 months prior to the study of functional food enriched with leucine or nutritional supplement based on protein concentrate or that presents in its chemical composition leucine.
* Presence of absolute or relative contraindications ruled by the American College of Sports Medicine (ACSM, 1995), during the performance of stress tests.
* Presence of chronic diseases that prevent the performance of a physical exercise program or an exercise test (disabling arthropathies, moderate / severe chronic lung diseases, ischemic heart disease under treatment, arrhythmias, etc).
* Abuse in the ingestion of alcohol.
* Present hypersensitivity or intolerance to any of the components of the products under study.
* Inability to understand informed consent.

Primary outcomes:
measure: Muscle mass
timeFrame: Change of this measurement at 3 months.
measure: Total fat mass
timeFrame: Change of this measurement at 3 months.
measure: Total fat free mass
timeFrame: Change of this measurement at 3 months.
measure: Fat free mass on upper limb
timeFrame: Change of this measurement at 3 months.
measure: Upper limb fat mass
timeFrame: Change of this measurement at 3 months.
measure: Fat-free mass in the lower limb
timeFrame: Change of this measurement at 3 months.
measure: Lower limb fat mass
timeFrame: Change of this measurement at 3 months.
Secondary outcomes:
measure: Elbow extension
timeFrame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
measure: Elbow flexion
timeFrame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
measure: Knee extension
timeFrame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
measure: Knee flexion
timeFrame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
measure: Blood samples: Glycid metabolism and lipid metabolism.
timeFrame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
measure: Liver safety variables
timeFrame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References: