Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

NCT03835416 | Completed Results DMC

• 1 other identifier: E2843-R
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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".

Conditions

Prediabetes; Obesity

Keywords

obesity; prediabetic state; older person; diet, reducing; protein; muscle function

Outcome Measures

Primary Outcomes (3)

• Total Short Physical Performance Battery (SPPB) Score at Baseline

  SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning.

  0 months

• Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months

  SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 3 months minus the value at baseline.

  Baseline and 3 months

• Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months

  SPPB total score is the sum of scores from 3 measures, namely balance, gait speed, and chair stands. Score scale 0-12. Higher numbers indicate higher functioning. The change score is determined by the value at 6 months minus the value at baseline.

  Baseline and 6 months

Secondary Outcomes (50)

• Percent Change in Body Weight at 3 Months

  Baseline and 3 months

• Percent Change in Body Weight at 6 Months

  Baseline and 6 months

• Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months

  Baseline and 3 months

• Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months

  6 months

• Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months

  Baseline and 3 months

Study Arms (2)

WL-Control

EXPERIMENTAL

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

WL-Protein

EXPERIMENTAL

\>30 g of high quality protein per meal, 1.4 g protein/kg body weight/day. 21 servings of high quality (30 g/serving) protein (lean meats, whey protein powder, protein drinks) provided to participants each week to increase compliance.

Dietary Supplement: Foods rich in high quality protein

Interventions

Foods rich in high quality protein DIETARY_SUPPLEMENT

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).

WL-Control; WL-Protein

Eligibility Criteria

• Age: 55 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

Location

MeSH Terms

Conditions

Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The outcomes for which data are missing have the following explanations: 1. Data were collected but the data analysis is still in progress. 2. We were unable to collect the outcome due to financial and logistical restrictions or the inability to establish satisfactory sample collection processes.

Results Point of Contact

• Title: Dr. Connie Bales, Assoc. Director, GRECC
• Organization: Durham VA Medical Center

connie.bales@va.gov

919-286-0411

Study Officials

• Connie W Bales, PhD RD

  Durham VA Medical Center, Durham, NC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Those responsible for outcomes assessment will be blinded from group treatment arm to every extent possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 8, 2019
• Study Start: December 12, 2019
• Primary Completion: March 26, 2024
• Study Completion: March 31, 2024
• Last Updated: June 6, 2025
• Results First Posted: June 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)