NCT02281331

Brief Summary

As we age we tend to lose muscle mass and strength. These losses contribute to the increased incidence of falls and fractures, metabolic diseases such as type 2 diabetes, loss of independence and reduced quality of life in the elderly. As the number of seniors increases worldwide, it is becoming more and more important to develop strategies to counteract this loss of muscle mass and strength, and promote healthy aging. Fortunately, relatively simple lifestyle modifications are the most potent defense strategies. Exercises such as weight lifting and high-intensity interval exercise (HIIT), which consists of short, repeated bouts of vigorous aerobic exercise interspersed with period of rest, are the most effective in promoting gains in muscle mass and strength. Additionally, components of foods like whey (a protein found in milk), creatine (found in meat), calcium and vitamin D have been shown to independently increase strength. In this study, we are looking to determine how much we can increase muscle strength in older men who are put on an 12 week exercise training program that combines weight lifting and HIIT, and who consume a daily supplement that contains whey protein, creatine, calcium and vitamin D.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

2.2 years

First QC Date

October 8, 2014

Last Update Submit

August 14, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Muscle mass

    DXA, ultrasound

    12 weeks

Secondary Outcomes (4)

  • Muscle protein synthesis

    12 weeks

  • Satellite cell number, density, type I/type II fibre specific satellite cells and myonuclear domain

    12 weeks

  • Glycemic control

    12 weeks

  • Cognitive function

    12 weeks

Study Arms (2)

Supplement

ACTIVE COMPARATOR

Each day, participants in this group will receive a supplement that provides a total of protein, creatine monohydrate, calcium, vitamin D and carbohydrate. This supplement will be provided to participants in beverage format, twice daily.

Dietary Supplement: Supplement

Placebo

PLACEBO COMPARATOR

The placebo will provide participants with maltodextrin (carbohydrate) and sucrose.

Dietary Supplement: Supplement

Interventions

SupplementDIETARY_SUPPLEMENT

supplement/placebo plus exercise training

PlaceboSupplement

Eligibility Criteria

Age60 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sedentary (no participation in a structured exercise training program in past 6 months)
  • BMI between 18.5-30.0 kg/m2
  • Weight stable for past 6 months
  • Normal resting blood pressure, or stage I hypertension

You may not qualify if:

  • Smoking
  • Use of simvastatin or atorvastatin
  • Use of non-steroidal anti-inflammatory drugs
  • Injuries that prevent safe-participation in an exercise training program
  • Prescription blood thinners
  • Diabetes or other metabolic disorders
  • Cardiac or gastro-intestinal problems
  • Infectious disease or cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster Univeristy

Hamilton, Ontario, L8S 4K1, Canada

Location

Related Publications (4)

  • Bell KE, Fang H, Snijders T, Allison DJ, Zulyniak MA, Chabowski A, Parise G, Phillips SM, Heisz JJ. A Multi-Ingredient Nutritional Supplement in Combination With Resistance Exercise and High-Intensity Interval Training Improves Cognitive Function and Increases N-3 Index in Healthy Older Men: A Randomized Controlled Trial. Front Aging Neurosci. 2019 May 9;11:107. doi: 10.3389/fnagi.2019.00107. eCollection 2019.

  • Bell KE, Brook MS, Snijders T, Kumbhare D, Parise G, Smith K, Atherton PJ, Phillips SM. Integrated Myofibrillar Protein Synthesis in Recovery From Unaccustomed and Accustomed Resistance Exercise With and Without Multi-ingredient Supplementation in Overweight Older Men. Front Nutr. 2019 Apr 11;6:40. doi: 10.3389/fnut.2019.00040. eCollection 2019.

  • Snijders T, Bell KE, Nederveen JP, Saddler NI, Mazara N, Kumbhare DA, Phillips SM, Parise G. Ingestion of a Multi-Ingredient Supplement Does Not Alter Exercise-Induced Satellite Cell Responses in Older Men. J Nutr. 2018 Jun 1;148(6):891-899. doi: 10.1093/jn/nxy063.

  • Bell KE, Snijders T, Zulyniak M, Kumbhare D, Parise G, Chabowski A, Phillips SM. A whey protein-based multi-ingredient nutritional supplement stimulates gains in lean body mass and strength in healthy older men: A randomized controlled trial. PLoS One. 2017 Jul 18;12(7):e0181387. doi: 10.1371/journal.pone.0181387. eCollection 2017.

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stuart Phillips, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 8, 2014

First Posted

November 3, 2014

Study Start

October 1, 2014

Primary Completion

December 1, 2016

Study Completion

May 1, 2018

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations