Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein

Obesity Clinical Trial

— VALOR-UP  

Official title:

Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835416
• Other study ID #: E2843-R
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: March 29, 2024

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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 55 + 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) 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: March 29, 2024
• Est. primary completion date: March 26, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 55 Years and older

Eligibility

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 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

--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

Related Conditions & MeSH terms

• Obesity
• Prediabetes

Intervention

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).

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Short Physical Performance Battery (SPPB)	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	0, 3 and 6 months
Primary	Change in Short Physical Performance Battery (SPPB)	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	0, 3, 6 months
Primary	Change in Short Physical Performance Battery (SPPB)	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	0, 3, 6 months
Secondary	Change in Body Weight	Same scale, light clothing and no shoes, measured to nearest 0.1 kg	0, 3 and 6 months
Secondary	Change in 6 Minutes Walk Test (aerobic endurance)	As many walking laps as possible in six minutes between cones placed 40 meters apart	0, 3 and 6 months
Secondary	Change in 8-ft Up and Go (agility/dynamic balance)	Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated.	0,3, and 6 months
Secondary	Change in 30 second chair stands (lower body strength)	With arms across chest, stand up completely, returns to seated as many times as possible in 30 seconds.	0, 3, and 6 months
Secondary	Change in Isokinetic knee extension peak torque (muscle strength)	Knee extensor at 60 degrees with a dynamometer (HUMAC NORM Isokinetic Extremity System). Average peak torque for three trials will be recorded.	0, 3, and 6 months
Secondary	Change in Computerized Axial Tomography (CAT) scan	Cross sectional area of the thigh without contrast to determine muscle mass.	0, 3, and 6 months
Secondary	Change in Isometric hand grip (upper body strength)	Jamar Hand Dynamometer (Sammons Preston Rolyan). Highest of three trials/hand.	0, 3, and 6 months
Secondary	Change in Minimal Waist Circumference	At smallest horizontal circumference above umbilicus and below xiphoid process.	0, 3, and 6 months
Secondary	Change in Body Composition: BodPod	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.	0, 3, and 6 months
Secondary	Change in number of falls and fear of falling	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?"	0, 3, 6 months
Secondary	Mini-Cog	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.	Baseline
Secondary	Change in Short Form-36 (SF-36) Health Survey	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	0, 3, 6, 9, 12 months
Secondary	Change in Profile of Mood States (POMS)	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).	0, 3, 6, 9, 12 months
Secondary	Change in Center for Epidemiologic Studies Depression Scale (CES-D)	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).	0, 3, 6, 9, 12 months
Secondary	Change in Perceived Stress Scale (PSS)	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.	0, 3, 6, 9, 12 months
Secondary	Change in Pittsburgh Sleep Quality Index (PSQI)	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.	0, 3, 6, 9, 12 months
Secondary	Change in Satisfaction with Life Scale (SWLS)	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.	0, 3, 6, 9, 12 months
Secondary	Change in 3-day diet record	3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research);	0, 3, 6, [9, 12] months
Secondary	Change in Protein Checklist Form	RedCap analysis for protein they have consumed	0,1,2,3,4,5,6 months
Secondary	Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity)	Actigraph WGT3X-BT activity counts at 1-s epoch from three orthogonal axes at 30 Hz sampling frequency.	0, 3, 6 months (7 days each time point)
Secondary	Change in Metabolic Panel (LabCorp)- A Blood Draw and testing	Routine chemistries, blood testing	0, 3, 6 months
Secondary	Change in Glucose Tolerance Test (OGTT) (78-80), blood	Ingestion of a 75 g glucose load with blood draws at 0, 10, 20, 30, 60, 90, 120, 150 and 180 minutes.	0, 3, 6 months
Secondary	Change in Daily food journal (Adherence)	Daily food journal assessed by RD every week	we will collect the daily food journal Up to 36 weeks through study completation