- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835416
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein (VALOR-UP)
Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Connie W Bales, PhD RD
- Phone Number: 6780 (919) 286-0411
- Email: connie.bales@va.gov
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27705-3875
- Durham VA Medical Center, Durham, NC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male Veterans
- African American or Caucasian
- Obese (BMI > 30 kg/m2)
- Age 55+ years
- Pre-diabetes (confirmed fasting plasma glucose 100 and <126 mg/dL) or HbA1c 5.7-6.4%
- Short Physical Performance Battery score of 4 to 10 units
- Age-normal renal function
- English speaking
- Able to record dietary intake or has a proxy who can record dietary intake
- Willing and able to be randomized to either intervention group
Exclusion Criteria:
- Presence of unstable or symptomatic life-threatening illness
Glomerular filtration rates (GFR) less than 45 mL/min
- A GFR of 45-59 requires bi-monthly testing per the investigators' established algorithm
- Those with a GFR <45 mL/min are excluded
Mini Cog score of <3
--Vegetarian
Neurological conditions causing functional impairments, including:
- Parkinson's Disease
- multiple sclerosis
- permanent disability due to stroke
- Inability to complete physical function assessment
- History of significant weight instability
- Contraindicated medications, including narcotic mail-outs and active substance abuse
- Any psychiatric condition that would prevent the subject from participating in a group intervention setting, including diagnosed personality disorders
- Primary care provider disapproves participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WL-Control
0.8 g protein per kg body weight.
Seven servings of whey protein powder (15 g/serving) per week will be provided to participants to support diet affordability.
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Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description).
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Experimental: WL-Protein
>30 g of high quality protein per meal, 1.2 g protein/kg body weight/day.
Fourteen servings of high quality (30 g/serving) protein (lean meats, low fat dairy products) provided to participants each week to increase compliance.
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Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Short Physical Performance Battery (SPPB)
Time Frame: 0, 3 and 6 months
|
Three different Balance test-(side-by-side, semi-tandem, tandem). They hold each position for 10 seconds Possible Score for Balance Test: 0-4 Possible Score for whole SPPB Test 0-12 |
0, 3 and 6 months
|
Change in Short Physical Performance Battery (SPPB)
Time Frame: 0, 3, 6 months
|
Gait speed (4-meter timed walk)- we are measuring there normal walk speed. Possible Score for Gait Speed: 0-4 Possible Score for whole SPPB Test 0-12 |
0, 3, 6 months
|
Change in Short Physical Performance Battery (SPPB)
Time Frame: 0, 3, 6 months
|
Lower Body Strength-5 Chair Stand as fast as they can do. Chair Stand- With arms across chest, stand up completely, returns to seated Possible Score for Chair Stands: 0-4 Possible Score for whole SPPB Test 0-12 |
0, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: 0, 3 and 6 months
|
Same scale, light clothing and no shoes, measured to nearest 0.1 kg
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0, 3 and 6 months
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Change in 6 Minutes Walk Test (aerobic endurance)
Time Frame: 0, 3 and 6 months
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As many walking laps as possible in six minutes between cones placed 40 meters apart
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0, 3 and 6 months
|
Change in 8-ft Up and Go (agility/dynamic balance)
Time Frame: 0,3, and 6 months
|
Begins seated.
On word 'go' stands, walks around a cone 8 feet away, returns to seated.
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0,3, and 6 months
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Change in 30 second chair stands (lower body strength)
Time Frame: 0, 3, and 6 months
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With arms across chest, stand up completely, returns to seated as many times as possible in 30 seconds.
|
0, 3, and 6 months
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Change in Isokinetic knee extension peak torque (muscle strength)
Time Frame: 0, 3, and 6 months
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Knee extensor at 60 degrees with a dynamometer (HUMAC NORM Isokinetic Extremity System).
Average peak torque for three trials will be recorded.
|
0, 3, and 6 months
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Change in Computerized Axial Tomography (CAT) scan
Time Frame: 0, 3, and 6 months
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Cross sectional area of the thigh without contrast to determine muscle mass.
|
0, 3, and 6 months
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Change in Isometric hand grip (upper body strength)
Time Frame: 0, 3, and 6 months
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Jamar Hand Dynamometer (Sammons Preston Rolyan).
Highest of three trials/hand.
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0, 3, and 6 months
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Change in Minimal Waist Circumference
Time Frame: 0, 3, and 6 months
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At smallest horizontal circumference above umbilicus and below xiphoid process.
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0, 3, and 6 months
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Change in Body Composition: BodPod
Time Frame: 0, 3, and 6 months
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Air displacement plethysmography method (Life Measurement, Inc., Concord, CA).
The Cardio Pulmonary, Metabolic and Body Composition (COSMED) BodPod has excellent sensitivity and test-to-test reliability, ease of use, and non-invasive nature, which is important for full participation from this population.
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0, 3, and 6 months
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Change in number of falls and fear of falling
Time Frame: 0, 3, 6 months
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In-person interview with questionnaire.
This is a open ended questionnaire to see the change in number of times a person falls between time points.
Yes or no response to the question, "Do you have a fear of falling?"
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0, 3, 6 months
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Mini-Cog
Time Frame: Baseline
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Screens for cognitive impairment with minimal language content, reduces cultural and educational bias. A 3-item recall component plus a Clock Drawing Test. The items recall component Score: 3 The Normal Clock Drawing Score: 2 Eligible score to be in study is 3. |
Baseline
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Change in Short Form-36 (SF-36) Health Survey
Time Frame: 0, 3, 6, 9, 12 months
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Quality of Life Questionnaires The SF-36 measures 8 QOL domains which are dichotomized into physical (functioning, role limitations-physical, pain, general health) and mental health (vitality, social functioning, role limitations-emotional, and emotional/mental health).
Item scores were converted to a 0-100 point scale; domain scores were derived by averaging individual items within the subscale; and physical composite and mental health composite scores were derived by averaging the four component domains of each.
Higher values are indicative of better QOL
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0, 3, 6, 9, 12 months
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Change in Profile of Mood States (POMS)
Time Frame: 0, 3, 6, 9, 12 months
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Mood Questionnaires The 30-item POMS measures mood and mood changes, has low respondent burden, and includes 6 subscales: tension, depression, anger, fatigue, confusion and vigor (all with range 0-20).
Total mood disturbance (TMD) is derived from POMS using the following formula, TMD = (Sum of all subscales except vigor) - vigor (range -20 - 100).
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0, 3, 6, 9, 12 months
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Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 0, 3, 6, 9, 12 months
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Depression Questionnaires Individuals were coded as positive for depression if they had a CES-D score of 16 and/or had self-report of depression diagnosis at baseline.
In addition to the total score, the CES-D includes 4 subscales: depressed affect (range 0-21), positive affect (range 0-12), somatic (range 0-21), and interpersonal (range 0-6).
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0, 3, 6, 9, 12 months
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Change in Perceived Stress Scale (PSS)
Time Frame: 0, 3, 6, 9, 12 months
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Stress Questionnaires The PSS assesses the degree to which situations in one's life are considered stressful (range 0-40). Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
0, 3, 6, 9, 12 months
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Change in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 0, 3, 6, 9, 12 months
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Quality of sleep Questionnaires Reported PSQI values include only these six component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, and use of sleeping medication (all with a range 0-3). The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality. |
0, 3, 6, 9, 12 months
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Change in Satisfaction with Life Scale (SWLS)
Time Frame: 0, 3, 6, 9, 12 months
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Life Satisfaction Questionnaires The SWLS evaluates global life satisfaction, an important component of subjective well-being (range 5-35). The SWLS is a 7-point Likert scale style response scale. The possible range of scores is 5-35, with a score of 20 representing a neutral point on the scale. Scores between 5-9 indicate the respondent is extremely dissatisfied with life, whereas scores between 31-35 indicate the respondent is extremely satisfied. |
0, 3, 6, 9, 12 months
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Change in 3-day diet record
Time Frame: 0, 3, 6, [9, 12] months
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3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research);
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0, 3, 6, [9, 12] months
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Change in Protein Checklist Form
Time Frame: 0,1,2,3,4,5,6 months
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RedCap analysis for protein they have consumed
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0,1,2,3,4,5,6 months
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Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity)
Time Frame: 0, 3, 6 months (7 days each time point)
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Actigraph WGT3X-BT activity counts at 1-s epoch from three orthogonal axes at 30 Hz sampling frequency.
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0, 3, 6 months (7 days each time point)
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Change in Metabolic Panel (LabCorp)- A Blood Draw and testing
Time Frame: 0, 3, 6 months
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Routine chemistries, blood testing
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0, 3, 6 months
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Change in Glucose Tolerance Test (OGTT) (78-80), blood
Time Frame: 0, 3, 6 months
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Ingestion of a 75 g glucose load with blood draws at 0, 10, 20, 30, 60, 90, 120, 150 and 180 minutes.
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0, 3, 6 months
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Change in Daily food journal (Adherence)
Time Frame: we will collect the daily food journal Up to 36 weeks through study completation
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Daily food journal assessed by RD every week
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we will collect the daily food journal Up to 36 weeks through study completation
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Collaborators and Investigators
Investigators
- Principal Investigator: Connie W Bales, PhD RD, Durham VA Medical Center, Durham, NC
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E2843-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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