- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02069314
Diet and Muscle Function In Older Adults (S32)
February 19, 2014 updated by: Wayne Campbell, Purdue University
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity.
The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adults.
Study Overview
Status
Completed
Conditions
Detailed Description
This research study was conducted to investigate the effects of a high protein diet on the efficiency of energy use at rest and at low-levels of physical activity.
The hypothesis was that a high intake of dietary protein would result in a less efficient use of energy in skeletal muscle in older adult
Study Type
Interventional
Enrollment (Actual)
12
Phase
- 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
-
-
Indiana
-
West Lafayette, Indiana, United States, 47907
- Purdue 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
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 65 years and older
Exclusion Criteria:
- Diabetic
- Acute symptoms of cardiovascular disease or congestive heart failure
- uncontrolled hypertension
- supplemental oxygen consumption at rest or during exercise
- lactose intolerance
- inability to ride a stationary cycle
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
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Whey protein supplementation
50 grams of whey blended into frozen drink
|
subjects are asked to consume a smoothie with whey protein added
|
|
EXPERIMENTAL: Carbohydrate supplementation
50 grams of polycose blended into frozen drink
|
Subjects are asked to consume a beverage with polycose added
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dietary protein effects on muscle energy use
Time Frame: participants will be measured over an average of 26 days
|
gross mechanical efficiency of muscle, consuming high and low protein supplements
|
participants will be measured over an average of 26 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of protein supplements on food intake
Time Frame: participants will be measured over an average of 26 days
|
effects of high protein or high carbohydrate supplements on overall energy consumption in older adults.
|
participants will be measured over an average of 26 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
May 1, 2012
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
May 1, 2013
Study Registration Dates
First Submitted
February 12, 2014
First Submitted That Met QC Criteria
February 19, 2014
First Posted (ESTIMATE)
February 24, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
February 24, 2014
Last Update Submitted That Met QC Criteria
February 19, 2014
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1203012093
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.
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