Leucine-enriched Nutraceutical and Attenuating Muscle Loss

NCT03197402 | Completed

• 1 other identifier: 3390
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Muscle Loss

Keywords

Leucine; Protein; Supplementation

Outcome Measures

Primary Outcomes (1)

• Change from baseline molecular signalling

  protein synthetic pathway

  Through study completion, an average of 1 year

Secondary Outcomes (1)

• Change from baseline lean body mass

  Through study completion, an average of 1 year

Study Arms (2)

Comparator group

ACTIVE COMPARATOR

Milk protein gel delivery system supplementation

Dietary Supplement: Milk protein gel delivery system

Leucine-enriched protein group

EXPERIMENTAL

Leucine-enriched protein gel delivery system supplementation

Dietary Supplement: Leucine-enriched protein gel delivery system

Interventions

Leucine-enriched protein gel delivery system DIETARY_SUPPLEMENT

Leucine enriched

Leucine-enriched protein group

Milk protein gel delivery system DIETARY_SUPPLEMENT

Non-leucine enriched

Comparator group

Eligibility Criteria

• Age: 70 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• McMaster University: lead

Study Sites (4)

Exercise Metabolism Research Laboratory, McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Ivor Wynne Centre A103, McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

Location

McMaster University

Hamilton, Ontario, L8S4L8, Canada

Location

Related Publications (1)

• Sullivan DH, Sun S, Walls RC. Protein-energy undernutrition among elderly hospitalized patients: a prospective study. JAMA. 1999 Jun 2;281(21):2013-9. doi: 10.1001/jama.281.21.2013.

  PMID: 10359390 RESULT

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Stuart M Phillips, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: parallel group design (with repeated measurements within each group)

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 23, 2017
• Study Start: May 9, 2018
• Primary Completion: November 30, 2018
• Study Completion: March 1, 2019
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)