Elderly PersonLEUCINCT04345237
Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine
A study testing dietary supplement consumption in people with Elderly Person and Body Composition, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly Person, Body Composition, Physical Exercise
- What is being tested?
- dietary supplement consumption
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSpain
- Study dates
- 15 Nov 2019to 30 Apr 2020
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
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.
Read the 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.
- Conditions
- Elderly Person, Body Composition, Physical Exercise
- Being tested
- dietary supplement consumption
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary supplement consumptionDietary supplement
Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).
In addition, 5 of the arms perform physical activity training
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 (TS + placebo) | Experimental | Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits.
Daily consumption for 3 months of placebo milk. Receives: Dietary Supplement: dietary supplement consumption |
| Experimental group 2 (TS + leucine) | Experimental | Training twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits.
Daily consumption for 3 months of milk enriched with leucine. Receives: Dietary Supplement: dietary supplement consumption |
| Experimental group 3 (HRC + placebo) | Experimental | Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits.
Daily consumption for 3 months of placebo milk. Receives: Dietary Supplement: dietary supplement consumption |
| Experimental group 4 (HRC + leucine) | Experimental | Training twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits.
Daily consumption for 3 months of milk enriched with leucine. Receives: Dietary Supplement: dietary supplement consumption |
| Experimental group 5 (no physical exercise + leucine) | Experimental | The subjects will not carry out any type of physical activity.
Daily consumption for 3 months of milk enriched with leucine. Receives: Dietary Supplement: dietary supplement consumption |
| Control (no physical exercise + placebo) | No intervention | The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Total fat mass
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Total fat free mass
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Fat free mass on upper limb
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Upper limb fat mass
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Fat-free mass in the lower limb
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Lower limb fat mass
Dual X-ray absorptiometry (DEXA)
Measured: Change of this measurement at 3 months.
Secondary outcomes (6)
Elbow extension
Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
Measured: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Elbow flexion
Upper limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
Measured: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee extension
Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
Measured: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee flexion
Lower limb isokinetic dynamometry. The angular velocities used were 60 ° · s-1 and 270 ° · s-1. The variables measured for each of them were maximum isokinetic torque, maximum isokinetic torque in relation to body weight, total work and average power.
Measured: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Blood samples: Glycid metabolism and lipid metabolism.
Basic glucemia, total cholesterol, cholesterol HDL, cholesterol LDL, , triglycerides.
Measured: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
Liver safety variables
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver.
Measured: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start15 Nov 2019
- Primary completion15 Feb 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PersonStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier López Román, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345237
- Sponsor's protocol ID
- UCAMCFE-00013
- Acronym
- LEUCI
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial on Changes in Body Composition When Ingesting a Dairy Compound Enriched With Leucine Daily for 3 Months
- ClinicalTrials.gov ID
- NCT04345237
- Acronym / sponsor ID
- LEUCI / UCAMCFE-00013
- Conditions
- Elderly Person, Body Composition, Physical Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 14 Apr 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 (TS + placebo) | Experimental | Dietary Supplement: dietary supplement consumptionTraining twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
| Experimental group 2 (TS + leucine) | Experimental | Dietary Supplement: dietary supplement consumptionTraining twice a week, with wave periodization. Traditional training (TS) in two circuits. Each exercise is separated by a rest period of 3 minutes and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
| Experimental group 3 (HRC + placebo) | Experimental | Dietary Supplement: dietary supplement consumptionTraining twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of placebo milk. |
| Experimental group 4 (HRC + leucine) | Experimental | Dietary Supplement: dietary supplement consumptionTraining twice a week, with wave periodization. High intensity training (HRC) on two circuits. Each exercise is separated by a rest period of 35 seconds and 5 minutes between circuits. Daily consumption for 3 months of milk enriched with leucine. |
| Experimental group 5 (no physical exercise + leucine) | Experimental | Dietary Supplement: dietary supplement consumptionThe subjects will not carry out any type of physical activity. Daily consumption for 3 months of milk enriched with leucine. |
| Control (no physical exercise + placebo) | No intervention | –The subjects will not carry out any type of physical activity. Daily consumption for 3 months of placebo milk. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| dietary supplement consumptionConsumption of the product under study for 3 months, milk placebo or experimental product (leucine milk). In addition, 5 of the arms perform physical activity training | Dietary supplement | Experimental group 1 (TS + placebo), Experimental group 2 (TS + leucine), Experimental group 3 (HRC + placebo), Experimental group 4 (HRC + leucine), Experimental group 5 (no physical exercise + leucine) |
Primary outcome
Muscle mass
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Total fat mass
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Total fat free mass
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Fat free mass on upper limb
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Upper limb fat mass
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Fat-free mass in the lower limb
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
Lower limb fat mass
Time frame: Change of this measurement at 3 months.
Dual X-ray absorptiometry (DEXA)
6 secondary outcomes
Elbow extension
Time frame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Elbow flexion
Time frame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee extension
Time frame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Knee flexion
Time frame: This measurement is carried out in each of the groups, at the beginning (baseline) and at 3 months (end).
Blood samples: Glycid metabolism and lipid metabolism.
Time frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
Liver safety variables
Time frame: Blood samples will be taken twice, once at baseline, at the beginning of the trial and once at the end after 3 months.
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 21 May 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary supplement consumption in people with Elderly Person and Body Composition, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
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 3 inclusion and 6 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 21 May 2020. 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 Spain. 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. 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?
Muscle mass (time frame: Change of this measurement at 3 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2020; AzTrials last refreshed its copy on 30 Oct 2026.