Clinical trial NCT03835416: Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
Official title: Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Obesity
Keywords: obesity
prediabetic state
older person
diet, reducing
protein
muscle function
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-02-08
Enrollment: 105
Sex: MALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 (1.4 g/kg bw/d) weight loss diet with balanced protein at each meal.
Primary purpose: PREVENTION

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 quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, 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 VA mission to "maximize the physical and social autonomy of Veterans".

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 64 obese (BMI 30 kg/m2) male Veterans aged 55 + yrs, with mild to moderate functional impairments (Short Physical Performance Battery score of 4 to 11 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) 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 quantity and composition, glucose handling, lean body mass, recent falls and fear of falling, 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 randomized controlled trial of a balanced, higher-protein diet during a metabolic challenge (caloric restriction) in those with prediabetes also considers 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 and glucose handling, and explore racial differences in responses to obesity interventions.

Eligibility criteria: 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 11 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

Primary outcomes:
measure: Total Short Physical Performance Battery (SPPB) Score at Baseline
timeFrame: 0 months
measure: Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Percent Change in Body Weight at 3 Months
timeFrame: Baseline and 3 months
measure: Percent Change in Body Weight at 6 Months
timeFrame: Baseline and 6 months
measure: Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months
timeFrame: 6 months
measure: Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Isometric Hand Grip (Upper Body Strength) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Isometric Hand Grip (Upper Body Strength) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Minimal Waist Circumference at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Minimal Waist Circumference at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Body Composition: Percent Lean Mass at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Body Composition: Percent Lean Mass at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Body Composition: Percent Fat Mass at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Body Composition: Percent Fat Mass at 6 Months
timeFrame: Baseline and 6 months
measure: Mini-Cog at Baseline Only
timeFrame: Baseline only
measure: Change in Computerized Axial Tomography (CAT) Scan at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Computerized Axial Tomography (CAT) Scan at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Short Form-36 (SF-36) Health Survey at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Short Form-36 (SF-36) Health Survey at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Profile of Mood States (POMS) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Profile of Mood States (POMS) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Perceived Stress Scale (PSS) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Perceived Stress Scale (PSS) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months
timeFrame: Baseline and 3 months
measure: Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months
timeFrame: Baseline and 6 months
measure: Change in Satisfaction With Life Scale (SWLS) at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Satisfaction With Life Scale (SWLS) at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Hemoglobin A1c at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Hemoglobin A1c at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Fear of Falling at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Fear of Falling at 6 Months
timeFrame: Baseline and 6 months
measure: Change in Number of Falls at 3 Months
timeFrame: Baseline and 3 months
measure: Change in Number of Falls at 6 Months
timeFrame: Baseline and 6 months
measure: Change in 3-day Diet Record, Calories, at 3 Months
timeFrame: Baseline and 3 months
measure: Change in 3-day Diet Record, Calories, at 6 Months
timeFrame: Baseline and 6 months
measure: Change in 3-day Diet Record, Protein, at 3 Months
timeFrame: Baseline and 3 months
measure: Change in 3-day Diet Record, Protein, at 6 Months
timeFrame: Baseline and 6 months
measure: Number of Participants Measured Using an Axis Accelerometer (Actigraph)
timeFrame: Baseline
measure: Number of Participants Measured Using an Axis Accelerometer (Actigraph)
timeFrame: 3 months
measure: Number of Participants Measured Using an Axis Accelerometer (Actigraph)
timeFrame: 6 months
measure: Change in Glucose Tolerance Test (OGTT) (78-80), Blood
timeFrame: 3 months
measure: Change in Glucose Tolerance Test (OGTT) (78-80), Blood
timeFrame: 6 months
measure: Percent Attendance at Weekly Diet Class Between Baseline and 3 Months
timeFrame: Baseline and 3 months
measure: Percent Attendance at Weekly Diet Class Between Baseline and 6 Months
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Connie W Bales, PhD RD
role: PRINCIPAL_INVESTIGATOR
References: