N/A N=64 Randomized Single-blind Prevention

Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

Prediabetes · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT03835416 ↗

Enrolled (actual)

Serious AEs

1.0%

Results posted

Jun 2025

Primary outcome: Primary: Total Short Physical Performance Battery (SPPB) Score at Baseline — 9.5; 9.6 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Foods rich in high quality protein (Dietary_supplement)
Age: Adult, Older Adult · 55+ yrs
Sex: Male
Sponsor: VA Office of Research and Development
Primary completion: Mar 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Short Physical Performance Battery (SPPB) Score at Baseline	9.5; 9.6	—
PRIMARY Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months	1.22; 1.48	—
PRIMARY Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months	1.00; 1.85	—
SECONDARY Percent Change in Body Weight at 3 Months	-3.1; -4.7	—
SECONDARY Percent Change in Body Weight at 6 Months	-6.5; -6.2	—
SECONDARY Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months	34.32; 63.29	—
SECONDARY Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months	68.10; 65.90	—
SECONDARY Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months	-1.58; -1.90	—
SECONDARY Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months	-2.10; -2.12	—
SECONDARY Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months	—	—
SECONDARY Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months	—	—
SECONDARY Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months	-5.02; 4.66	—
SECONDARY Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months	-7.20; -3.98	—
SECONDARY Change in Isometric Hand Grip (Upper Body Strength) at 3 Months	0.85; 3.69	—
SECONDARY Change in Isometric Hand Grip (Upper Body Strength) at 6 Months	1.21; 3.01	—
SECONDARY Change in Minimal Waist Circumference at 3 Months	-2.64; -4.12	—
SECONDARY Change in Minimal Waist Circumference at 6 Months	-4.95; -4.81	—
SECONDARY Change in Body Composition: Percent Lean Mass at 3 Months	1.11; 2.37	—
SECONDARY Change in Body Composition: Percent Lean Mass at 6 Months	2.95; 3.31	—
SECONDARY Change in Body Composition: Percent Fat Mass at 3 Months	-1.11; -2.37	—
SECONDARY Change in Body Composition: Percent Fat Mass at 6 Months	-2.95; -3.31	—
SECONDARY Mini-Cog at Baseline Only	3.97; 4.06	—
SECONDARY Change in Computerized Axial Tomography (CAT) Scan at 3 Months	1.68; 4.65	—
SECONDARY Change in Computerized Axial Tomography (CAT) Scan at 6 Months	7.22; 2.43	—
SECONDARY Change in Short Form-36 (SF-36) Health Survey at 3 Months	—	—
SECONDARY Change in Short Form-36 (SF-36) Health Survey at 6 Months	—	—
SECONDARY Change in Profile of Mood States (POMS) at 3 Months	—	—
SECONDARY Change in Profile of Mood States (POMS) at 6 Months	—	—
SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months	—	—
SECONDARY Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months	—	—
SECONDARY Change in Perceived Stress Scale (PSS) at 3 Months	—	—
SECONDARY Change in Perceived Stress Scale (PSS) at 6 Months	—	—
SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months	—	—
SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months	—	—
SECONDARY Change in Satisfaction With Life Scale (SWLS) at 3 Months	—	—
SECONDARY Change in Satisfaction With Life Scale (SWLS) at 6 Months	—	—
SECONDARY Change in Hemoglobin A1c at 3 Months	—	—
SECONDARY Change in Hemoglobin A1c at 6 Months	—	—
SECONDARY Change in Fear of Falling at 3 Months	—	—
SECONDARY Change in Fear of Falling at 6 Months	—	—
SECONDARY Change in Number of Falls at 3 Months	—	—
SECONDARY Change in Number of Falls at 6 Months	—	—
SECONDARY Change in 3-day Diet Record, Calories, at 3 Months	—	—
SECONDARY Change in 3-day Diet Record, Calories, at 6 Months	—	—
SECONDARY Change in 3-day Diet Record, Protein, at 3 Months	—	—
SECONDARY Change in 3-day Diet Record, Protein, at 6 Months	—	—
SECONDARY Number of Participants Measured Using an Axis Accelerometer (Actigraph)	12; 20	—
SECONDARY Number of Participants Measured Using an Axis Accelerometer (Actigraph)	12; 20	—
SECONDARY Number of Participants Measured Using an Axis Accelerometer (Actigraph)	12; 20	—
SECONDARY Change in Glucose Tolerance Test (OGTT) (78-80), Blood	—	—
SECONDARY Change in Glucose Tolerance Test (OGTT) (78-80), Blood	—	—
SECONDARY Percent Attendance at Weekly Diet Class Between Baseline and 3 Months	—	—
SECONDARY Percent Attendance at Weekly Diet Class Between Baseline and 6 Months	—	—

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".

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03835416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.