Effect of Whey Protein Supplementation and Resistance Exercise on Muscle Parameters in Older Adults

• Sponsor: Tufts University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00635739
• Collaborator: National Dairy Council (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This research study is looking at the effects of a whey protein nutritional supplement on changes in muscle mass, strength and physical function in response to a 6 month program of strength training exercise.

Condition or Disease	Intervention/Treatment	Phase
Mobility Limitation	Dietary Supplement: Whey protein; Dietary Supplement: Maltodextrin placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of Whey Protein Supplementation on Resistance Exercise-Induced Changes in Muscle Strength, Fat Free Mass, and Function in Mobility-Limited Older Adults
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A, 1	Dietary Supplement: Whey protein; powdered, 46g supplement dissolved in fluids, twice daily
Placebo Comparator: A, 2	Dietary Supplement: Maltodextrin placebo; powdered, 46g supplement dissolved in fluids, twice daily

Outcome Measures

Primary Outcome Measures

1. 1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press [Baseline and follow up (6 months)]

   The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.

Secondary Outcome Measures

1. Lean Mass [Baseline and follow up (6 months)]

   Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male and Females 70-85 yrs

• Community dwelling

• Short Physical Performance Battery score < 10

• BMI = 21-32.5

Exclusion Criteria:

• Acute or terminal illness

• Mini Mental State Exam < 23

• Myocardial infarction in previous 6 months, symptomatic coronary artery disease, or congestive heart failure

• Upper or lower extremity fracture in previous 6 months

• Uncontrolled hypertension (>150/90 mm Hg).

• Neuromuscular diseases and drugs which affect neuromuscular function.

• Hormone replacement therapy

• eGFR <30 mL/min/1.73m2

• Types I and II Diabetes Mellitus

• Dietary protein intake < 0.8 g.kg-1.day-1

• Disorders of nutrient absorption

• Milk, or whey allergy

• Sulfa drugs and allergy to PABA-containing sunscreens

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jean Mayer USDA Human Nutrition Research Center on Aging	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts University
• National Dairy Council

Investigators

• Principal Investigator: Roger A Fielding, Ph.D., Jean Mayer USDA Human Nutrition Research Center on Aging

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roger A Fielding, Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging., Tufts University
• ClinicalTrials.gov Identifier: NCT00635739
• Other Study ID Numbers: 1493
• First Posted: Mar 14, 2008
• Last Update Posted: Mar 18, 2019
• Last Verified: Dec 1, 2018

• Keywords provided by Roger A Fielding, Director and Senior Scientist, Professor of Nutrition, Jean Mayer USDA Human Nutrition Research Center on Aging., Tufts University: Whey protein; Resistance exercise; Physical activity; Mobility disability; Physical function; Muscle mass; Muscle strength; Older Adults; Mobility-Limited
• Additional relevant MeSH terms: Mobility Limitation

Study Results

Participant Flow

Arm/Group Title	Whey Protein	Placebo
Arm/Group Description	Whey protein: powdered, 46g supplement dissolved in fluids, twice daily	Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Period Title: Overall Study
STARTED	42	38
COMPLETED	39	36
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	A,1 (Intervention)	A,2 (Control)	Total
Arm/Group Description	Whey protein: powdered, 46g supplement dissolved in fluids, twice daily	Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily	Total of all reporting groups
Overall Participants	42	38	80
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	42 100%	38 100%	80 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	78.0 (4.0)	77.3 (3.9)	77.7 (4.0)
Sex: Female, Male (Count of Participants)
Female	25 59.5%	22 57.9%	47 58.8%
Male	17 40.5%	16 42.1%	33 41.3%
Region of Enrollment (participants) [Number]
United States	42 100%	38 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	1 Repetition Maximum Muscle Strength 1-RM (N) Double Leg Press
Description	The maximum muscle strength of the leg extensor muscles as measured by pneumatic strength training equipment.
Time Frame	Baseline and follow up (6 months)

Outcome Measure Data

Analysis Population Description

5 subjects were not included in follow up analysis

Arm/Group Title	Whey Protein	Placebo
Arm/Group Description	Whey protein: powdered, 46g supplement dissolved in fluids, twice daily	Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Measure Participants	42	38
Baseline	1223 (380)	1256 (461)
Follow up	1483 (517)	1465 (528)

2. Secondary Outcome

Title	Lean Mass
Description	Whole body lean mass (kg) as measured by dual energy x-ray absorptiometry.
Time Frame	Baseline and follow up (6 months)

Outcome Measure Data

Analysis Population Description

5 subjects were not included in follow up analysis

Arm/Group Title	Whey Protein	Placebo
Arm/Group Description	Whey protein: powdered, 46g supplement dissolved in fluids, twice daily	Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
Measure Participants	42	38
Baseline	46.7 (8.6)	46.4 (8.4)
Follow up	47.3 (8.6)	46.7 (8.4)

Adverse Events

Time Frame	6 months
Arm/Group Title	Whey Protein		Placebo
Arm/Group Description	Whey protein: powdered, 46g supplement dissolved in fluids, twice daily		Maltodextrin placebo: powdered, 46g supplement dissolved in fluids, twice daily
All Cause Mortality
	Whey Protein		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Whey Protein		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/42 (14.3%)		3/38 (7.9%)
Cardiac disorders
Cardiovascular	2/42 (4.8%)		1/38 (2.6%)
General disorders
fall	1/42 (2.4%)		1/38 (2.6%)
hospitalization	3/42 (7.1%)		1/38 (2.6%)
Other (Not Including Serious) Adverse Events
	Whey Protein		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/42 (33.3%)		19/38 (50%)
Gastrointestinal disorders
GI distress	4/42 (9.5%)	4	2/38 (5.3%)	2
General disorders
Laboratory	3/42 (7.1%)	3	1/38 (2.6%)	1
Illness	5/42 (11.9%)	5	6/38 (15.8%)	6
Musculoskeletal and connective tissue disorders
Fall	0/42 (0%)	0	2/38 (5.3%)	2
Musculoskeletal	1/42 (2.4%)	1	3/38 (7.9%)	3
Surgical and medical procedures
Surgery	1/42 (2.4%)	1	5/38 (13.2%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.