Leucine-enriched Nutraceutical and Attenuating Muscle Loss

June 17, 2019 updated by: Stuart Phillips, McMaster University

Efficacy of a High Quality Protein Leucine-enriched Nutraceutical in Attenuating Inactivity- and Hypo-energetic Diet-induced Muscle Loss in Older Women

This leucine-enriched protein gummy (as a gummy bar/slab) will be studied to address age-related loss of muscle mass and strength/function in older persons. The product is small volume (approximately 35 g per serve) and low energy (approximately 100 kcal per serve). It is easy to chew and swallow with the consistency of a firm Jello. In addition, it contains an effective dose of leucine in a high-quality protein matrix consisting of milk proteins. Understanding the efficacy of this product on changes in levels of blood amino acids and the molecular signaling required to enhance muscle growth will provide helpful insight for the suggestion of supplemental use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

General experimental design:

Pre-testing will require participants to become familiarized with performing maximal voluntary isometric contractions, as well as touring the laboratory facilities. Participants will be asked to complete dietary records for three days to determine habitual caloric intake. The experimental trial will be conducted in three phases. A baseline run-in phase (Phase 1) during which participants will consume a diet matching their estimated energy requirement to put them in a weight-stable phase. Energy requirements will be estimated using the Harris Benedict equation using an appropriate physical activity factor based on interview responses to a standard activity questionnaire. Participants will then be assigned to either the comparator group (n=10) or leucine-enriched protein food group (n=10). For the subsequent 10d (Phase 2), participants will undergo a period of step reduction (< 1000 steps.d-1) whilst in a 500 kcal.d-1 deficit that will be adjusted for the reduced physical activity due to the step reduction. The reason for inducing an energy deficit is to mimic a situation where older individuals will be both physically inactive and 'undernourished', such as during home-bound periods of sickness or while in hospital. After completing Phase 2, participants will then return to their normal step count (from measured habitual steps pre-intervention) under energy balanced conditions for 10d that will serve as a recovery phase, Phase 3. We will complete assessments of body composition, leg lean mass, maximal voluntary isometric strength, measures of physical performance, and rate of force development will be made. Skeletal muscle biopsies will be obtained for biochemical analysis. At these time points, maximal voluntary isometric force, maximal leg press strength, a battery of physical performance measures and body composition will once again be obtained.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster University
      • Hamilton, Ontario, Canada, L8S 4K1
        • Exercise Metabolism Research Laboratory, McMaster Univeristy
      • Hamilton, Ontario, Canada, L8S4L8
        • McMaster University
      • Hamilton, Ontario, Canada, L8S 4K1
        • Ivor Wynne Centre A103, McMaster University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females between 70 and 75 years of age (a narrow age range improved homogeneity of the sample for this proof-of-concept trial) with a body mass index (BMI) between 27 and 35, and muscle mass 1 standard deviation below that of sex- and ethnicity-matched 30 year olds (note: this has been called 'stage 1 sarcopenia' or 'pre-sarcopenia') will be recruited. In addition, participants will be non-smokers and generally healthy per responses to a standard health screening questionnaire.

Exclusion Criteria:

  • Participants who have any one of the following conditions will be excluded:

    • diabetes mellitus
    • cardiovascular disease
    • renal disease
    • gastrointestinal disease
    • musculoskeletal injuries
    • hormone replacement therapy
    • significant weight loss in the 3-month period prior to the study
    • vegan diet
    • dairy protein allergy
    • use of medications known to interfere with muscle metabolism. For example, chronically taking any analgesic or anti-inflammatory drugs(s), prescription or non-prescription
    • a history of neuromuscular problems or muscle and/or bone wasting diseases
    • any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
    • use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Comparator group
Milk protein gel delivery system supplementation
Dietary supplement: Milk protein gel delivery system
Non-leucine enriched
Experimental: Leucine-enriched protein group
Leucine-enriched protein gel delivery system supplementation
Dietary supplement: Leucine-enriched protein gel delivery system
Leucine enriched

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline molecular signalling
Time Frame: Through study completion, an average of 1 year
protein synthetic pathway
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline lean body mass
Time Frame: Through study completion, an average of 1 year
body composition
Through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

These data will not be shared with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Muscle Loss

Clinical Trials on Milk protein gel delivery system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings