Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 3/9/2019 |
| Start Date: | June 3, 2019 |
| End Date: | March 31, 2023 |
| Contact: | Connie W Bales, PhD RD |
| Email: | connie.bales@va.gov |
| Phone: | (919) 286-0411 |
Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
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".
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".
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.
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.
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
We found this trial at
1
site
Durham, North Carolina 27705
Principal Investigator: Connie W Bales, PhD RD
Phone: 919-286-0411
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