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Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein (VALOR-UP)

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ClinicalTrials.gov Identifier: NCT03835416
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Diabetes is a major health concern in obese older Veterans, especially in those who are African American. The negative impact of diabetes on muscle and physical function contributes to metabolic as well as physical decline and is under-studied. This randomized controlled trial compares a higher-protein, weight loss regimen previously shown to improve physical function to an Recommended Dietary Allowance (RDA) protein intervention in obese older male Veterans with pre-diabetes and functional limitations. Equal numbers of white and black male Veterans will be studied, filling gaps in the investigators' knowledge of differential responses by race as well as obesity interventions for men in general. The primary outcome is functional performance by Short Physical Performance Battery and secondary measures include muscle quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of falling, instrumental activities of daily living, and quality of life measured at 0, 3 and 6 months. The goal of this research is to accelerate functional recovery and enhance independence in obese male Veterans, which is strongly aligned with the RR&D mission to "maximize the physical and social autonomy of Veterans".

Condition or disease Intervention/treatment Phase
Prediabetes Obesity Dietary Supplement: Foods rich in high quality protein Not Applicable

Detailed Description:
This study examines an evidence-based obesity intervention as a means of reducing the impact of prediabetes on muscle function in obese older men of white and black race. A total of 168 obese (BMI 30 kg/m2) male Veterans aged 60 yrs, with mild to moderate functional impairments (Short Physical Performance Battery score of 4 to 10 units) and prediabetes, will be randomized to a higher-protein weight loss treatment (HP-WL) or an RDA-level protein control weight loss treatment (C-WL). All participants receive individualized calorie prescriptions calculated to achieve a weight loss of ~1-2 pounds per week and attend weekly group support sessions designed to enhance diet compliance with goal setting, self-monitoring, stress management, and daily diet journaling. They will also attend a weekly low impact, chair exercise class. HP-WL participants are provided a supply of chilled/frozen high-quality protein foods (lean meats, low fat dairy products, eggs) sufficient to give 30 g high quality protein for two of three meals daily to help assure diet compliance. C-WL participants are provided 1 serving per day of high quality protein to avoid unintentional bias. Treatment responses will be compared for the primary outcome of functional performance by Short Physical Performance Battery and important secondary measures, including muscle quality, insulin sensitivity, lean body mass, physical activity, recent falls and fear of falling, instrumental activities of daily living, and quality of life at 0, 3 and 6 months. An exploratory aim examines potential mediators of racial differences in treatment responses and documents the most successful intervention strategies. This will be the first randomized controlled trial of a balanced, higher-protein diet during a metabolic challenge (caloric restriction) in those with prediabetes and the first study to look at racial differences in responses of obese older men to this regimen. Study findings will fulfill the RR&D mission by advancing interventions to improve physical function in older Veterans, yield novel information about the impact of balanced, higher protein on muscle quality and insulin sensitivity, and explore racial differences in responses to obesity interventions.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-armed Randomized Controlled Trial. Control group follows RDA-level (0.8 g/kg bw/d)protein weight loss diet. Protein follows higher protein (1.2 g/kg bw/d) weight loss diet with balanced protein at each meal.
Masking: Single (Outcomes Assessor)
Masking Description: Those responsible for outcomes assessment will be blinded from group treatment arm to every extent possible.
Primary Purpose: Prevention
Official Title: Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 16, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

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.
Dietary Supplement: Foods rich in high quality protein
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).

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, whey protein, low fat dairy and egg products) provided to participants each week to increase compliance.
Dietary Supplement: Foods rich in high quality protein
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).




Primary Outcome Measures :
  1. 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


  2. 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


  3. 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



Secondary Outcome Measures :
  1. Change in Body Weight [ Time Frame: 0, 3 and 6 months ]
    Same scale, light clothing and no shoes, measured to nearest 0.1 kg

  2. Change in 6 Minutes Walk Test (aerobic endurance) [ Time Frame: 0, 3 and 6 months ]
    As many walking laps as possible in six minutes between cones placed 40 meters apart

  3. 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.

  4. Change in 30 second chair stands (lower body strength) [ Time Frame: 0, 3, and 6 months ]
    With arms across chest, stand up completely, returns to seated as many times as possible in 30 seconds.

  5. Change in Isokinetic knee extension peak torque (muscle strength) [ Time Frame: 0, 3, and 6 months ]
    Knee extensor at 60 degrees with a dynamometer (HUMAC NORM Isokinetic Extremity System). Average peak torque for three trials will be recorded.

  6. Change in Computerized Axial Tomography (CAT) scan [ Time Frame: 0, 3, and 6 months ]
    Cross sectional area of the thigh without contrast to determine muscle mass.

  7. Change in Isometric hand grip (upper body strength) [ Time Frame: 0, 3, and 6 months ]
    Jamar Hand Dynamometer (Sammons Preston Rolyan). Highest of three trials/hand.

  8. Change in Minimal Waist Circumference [ Time Frame: 0, 3, and 6 months ]
    At smallest horizontal circumference above umbilicus and below xiphoid process.

  9. Change in Body Composition: BodPod [ Time Frame: 0, 3, and 6 months ]
    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.

  10. Change in number of falls and fear of falling [ Time Frame: 0, 3, 6 months ]
    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?"

  11. Mini-Cog [ Time Frame: Baseline ]

    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.


  12. Change in Short Form-36 (SF-36) Health Survey [ Time Frame: 0, 3, 6, 9, 12 months ]
    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

  13. Change in Profile of Mood States (POMS) [ Time Frame: 0, 3, 6, 9, 12 months ]
    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).

  14. Change in Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: 0, 3, 6, 9, 12 months ]
    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).

  15. Change in Perceived Stress Scale (PSS) [ Time Frame: 0, 3, 6, 9, 12 months ]

    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.


  16. Change in Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 0, 3, 6, 9, 12 months ]

    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.


  17. Change in Satisfaction with Life Scale (SWLS) [ Time Frame: 0, 3, 6, 9, 12 months ]

    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.


  18. Change in 3-day diet record [ Time Frame: 0, 3, 6, [9, 12] months ]
    3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research);

  19. Change in Protein Checklist Form [ Time Frame: 0,1,2,3,4,5,6 months ]
    RedCap analysis for protein they have consumed

  20. Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity) [ Time Frame: 0, 3, 6 months (7 days each time point) ]
    Actigraph WGT3X-BT activity counts at 1-s epoch from three orthogonal axes at 30 Hz sampling frequency.

  21. Change in Metabolic Panel (LabCorp)- A Blood Draw and testing [ Time Frame: 0, 3, 6 months ]
    Routine chemistries, blood testing

  22. Change in Glucose Tolerance Test (OGTT) (78-80), blood [ Time Frame: 0, 3, 6 months ]
    Ingestion of a 75 g glucose load with blood draws at 0, 10, 20, 30, 60, 90, 120, 150 and 180 minutes.

  23. Change in Daily food journal (Adherence) [ Time Frame: we will collect the daily food journal Up to 36 weeks through study completation ]
    Daily food journal assessed by RD every week



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male Veterans
  • African American or Caucasian
  • Obese (BMI > 30 kg/m2)
  • Age > 60 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835416


Contacts
Contact: Connie W Bales, PhD RD (919) 286-0411 ext 6780 connie.bales@va.gov

Locations
United States, North Carolina
Durham VA Medical Center, Durham, NC Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Connie W Bales, PhD RD    919-286-0411 ext 6780    connie.bales@va.gov   
Principal Investigator: Connie W Bales, PhD RD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Connie W Bales, PhD RD Durham VA Medical Center, Durham, NC

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03835416     History of Changes
Other Study ID Numbers: E2843-R
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
obesity
prediabetic state
older person
diet, reducing
protein
muscle function

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Prediabetic State
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases