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Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons

Primary Purpose

Aging, Sarcopenia

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Immunocal

Casein

About this trial

This is an interventional health services research trial for Aging focused on measuring Elderly persons, Muscle function and strength, Body composition, Inflammatory cytokine levels, Cognitive functions, Cysteine-rich whey protein isolate, Immunocal, Resistance training, Improved muscle function, Improved quality of life, Aging processes, Quality of life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 65 or older
Estimated GFR above 45ml/min
Total bilirubin in the normal range (0.2 to 1.2 mg/dl) AST (10-35 U/L for women and 10-50 U/L for men). ALT equal to or less than 2.5 times the upper limit of normal
BMI between 18.5-29.9 (kg)/m2
Sedentary (< 2 hours of structured exercise)in the last 2 or 3 months
Based on investigator judgment according to current Canadian guidelines, medical conditions such as hypertension, diabetes and hyperlipidemia have to be stable and optimally controlled before the subject starts the study.

Exclusion Criteria:

History of angioedema or allergic reactions to any compound used in this study.
Milk protein intolerance
Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements.
Major surgery in the year prior to testing
Acute coronary or vascular event within the last year or progressive angina
Stroke within the past 2 years
Neurologist and/or orthopedic limitations
Uncontrolled thyroid or pituitary disease
Medication which has a major affect on cognitive function
Signs of early dementia as assessed by Mini-Mental State Examination
Weight loss of more than 4kg(or more than 5% body weight) over last 6 months
Alcohol abuse
Medication which interferes with muscle mass i.e. (corticosteroids)
Any life threatening conditions based on Investigator judgment.
Subjects with allergies/intolerance to soya.
Subjects currently undergoing immunosuppressive therapy.

Sites / Locations

Institut de recherches cliniques de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Immunocal

Casein

Arm Description

20g of Immunocal

20g of Casein

Outcomes

Primary Outcome Measures

The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment

Secondary Outcome Measures

The mean of percent change in muscle strength based on hand-grip dynamometer

Percent change in lean body mass evaluated by DEXA.

The change in the plasma concentrations of Tumor Necrosis Factor-alpha (TNF-alpha), interleukin-6 (IL-6), C-reactive protein (CRP), glutathione, cysteine, asparagine, leucine and albumin

The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).

Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).

The % change in body weight.

Bone mass density

6-min walk test

Full Information

NCT ID

NCT00935610

First Posted

July 7, 2009

Last Updated

February 8, 2021

Sponsor

Immunotec Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00935610

Brief Title

Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons

Official Title

Effect of the Cysteine-rich Whey Protein Isolate (Immunocal®) in Combination With Physical Exercise on Muscle Function, Body Composition and Inflammatory Cytokine Levels in Elderly Persons: A Randomized, Double-blind Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunotec Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Aging is typically associated with a decrease in skeletal muscle mass and muscle function, which contributes decisively to disability in old age and to the loss of quality of life.Resistance exercise can increase muscle strength, function and mass in older adults. The primary aim of this study is to determine whether the combination of resistance training with a supplementation of a cysteine- rich whey protein isolate (Immunocal) compared to combination of resistance training with casein used as control (casein contains little cysteine) could have the potential to provide a synergic beneficial impact on muscle mass and function which could translate to an improved quality of life in elderly persons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aging, Sarcopenia

Keywords

Elderly persons, Muscle function and strength, Body composition, Inflammatory cytokine levels, Cognitive functions, Cysteine-rich whey protein isolate, Immunocal, Resistance training, Improved muscle function, Improved quality of life, Aging processes, Quality of life

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

99 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunocal

Arm Type

Active Comparator

Arm Description

20g of Immunocal

Arm Title

Casein

Arm Type

Placebo Comparator

Arm Description

20g of Casein

Intervention Type

Dietary Supplement

Intervention Name(s)

Immunocal

Intervention Description

20 grams per day of Immunocal for 135 days.

Intervention Type

Dietary Supplement

Intervention Name(s)

Casein

Intervention Description

20 grams per day for 135 days

Primary Outcome Measure Information:

Title

The mean of percent change in muscle strength based on leg press and chest press evaluation assessed by resistance training equipment

Time Frame

45, 90, 135 days

Secondary Outcome Measure Information:

Title

The mean of percent change in muscle strength based on hand-grip dynamometer

Time Frame

45, 90 and 135 days

Title

Percent change in lean body mass evaluated by DEXA.

Time Frame

40, 90 and 135 days

Title

The change in the plasma concentrations of Tumor Necrosis Factor-alpha (TNF-alpha), interleukin-6 (IL-6), C-reactive protein (CRP), glutathione, cysteine, asparagine, leucine and albumin

Time Frame

40, 90 and 135 days

Title

The clinical assessment of subject performance status (Quality of life and cognition, Physical Performance Test (PPT)).

Time Frame

40, 90 and 135 days

Title

Insulin sensitivity evaluated by fasting plasma glucose and insulin (HOMA-IR model).

Time Frame

40, 90 and 135 days

Title

The % change in body weight.

Time Frame

40, 90 and 135 days

Title

Bone mass density

Time Frame

40, 90 and 135 days

Title

6-min walk test

Time Frame

40, 90 and 135 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 65 or older Estimated GFR above 45ml/min Total bilirubin in the normal range (0.2 to 1.2 mg/dl) AST (10-35 U/L for women and 10-50 U/L for men). ALT equal to or less than 2.5 times the upper limit of normal BMI between 18.5-29.9 (kg)/m2 Sedentary (< 2 hours of structured exercise)in the last 2 or 3 months Based on investigator judgment according to current Canadian guidelines, medical conditions such as hypertension, diabetes and hyperlipidemia have to be stable and optimally controlled before the subject starts the study. Exclusion Criteria: History of angioedema or allergic reactions to any compound used in this study. Milk protein intolerance Subjects currently using N-acetylcysteine, alpha-lipoic acid supplements, or dry whey protein supplements. Major surgery in the year prior to testing Acute coronary or vascular event within the last year or progressive angina Stroke within the past 2 years Neurologist and/or orthopedic limitations Uncontrolled thyroid or pituitary disease Medication which has a major affect on cognitive function Signs of early dementia as assessed by Mini-Mental State Examination Weight loss of more than 4kg(or more than 5% body weight) over last 6 months Alcohol abuse Medication which interferes with muscle mass i.e. (corticosteroids) Any life threatening conditions based on Investigator judgment. Subjects with allergies/intolerance to soya. Subjects currently undergoing immunosuppressive therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Remi Rabasa-Lhoret, MD. Ph.D.

Organizational Affiliation

Institut de Recherches Cliniques de Montreal

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de recherches cliniques de Montréal

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1R7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25923482

Citation

Karelis AD, Messier V, Suppere C, Briand P, Rabasa-Lhoret R. Effect of cysteine-rich whey protein (immunocal(R)) supplementation in combination with resistance training on muscle strength and lean body mass in non-frail elderly subjects: a randomized, double-blind controlled study. J Nutr Health Aging. 2015 May;19(5):531-6. doi: 10.1007/s12603-015-0442-y.

Results Reference

derived

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Effect of Immunocal® With Exercise Versus Casein With Exercise on Aging Processes in Elderly Persons

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