PrediabetesVALOR-UPNCT03835416
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
A study testing Foods rich in high quality protein in people with Prediabetes and Obesity, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Prediabetes, Obesity
- What is being tested?
- Foods rich in high quality protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2019to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: 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 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".
Read the 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.
- Conditions
- Prediabetes, Obesity
- Being tested
- Foods rich in high quality protein
- Keywords
- obesity, prediabetic state, older person, diet, reducing, protein, muscle function
- Medical subject headings
- Prediabetic State, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foods rich in high quality proteinDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Foods rich in high quality protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 months
Secondary outcomes (50)
Percent Change in Body Weight at 3 Months
Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 3 months from weight at baseline, dividing by weight at baseline, and multiplying by 100.
Measured: Baseline and 3 months
Percent Change in Body Weight at 6 Months
Body weight was measured on the same scale, with light clothing and no shoes, measured to nearest 0.1 lbs. Percent change in body weight was calculated by subtracting weight at 6 months from weight at baseline, dividing by weight at baseline, and multiplying by 100.
Measured: Baseline and 6 months
Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months
Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 3 months from meters walked at baseline.
Measured: Baseline and 3 months
Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months
Meters walked in six minutes on a designated course. Change in meters walked was calculated by subtracting meters walked at 6 months from meters walked at baseline.
Measured: 6 months
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months
Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 3 months from time walked at baseline.
Measured: Baseline and 3 months
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months
Begins seated. On word 'go' stands, walks around a cone 8 feet away, returns to seated. Timing starts on 'go' and ends when seated. Change in time walked was calculated by subtracting time walked at 6 months from time walked at baseline.
Measured: Baseline and 6 months
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months
With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 3 months from number of chair stands at baseline.
Measured: Baseline and 3 months
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months
With arms across chest, stand up completely and return to seated as many times as possible in 30 seconds. Change in number of chair stands was calculated by subtracting number of chair stands at 6 months from number of chair stands at baseline.
Measured: Baseline and 6 months
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months
Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 3 months from peak torque at baseline.
Measured: Baseline and 3 months
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months
Knee extensor at 60 degrees with a dynamometer. Average peak torque for three trials will be recorded. Change in peak torque was calculated by subtracting peak torque at 6 months from peak torque at baseline.
Measured: Baseline and 6 months
Change in Isometric Hand Grip (Upper Body Strength) at 3 Months
Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 3 months from the highest value at baseline.
Measured: Baseline and 3 months
Change in Isometric Hand Grip (Upper Body Strength) at 6 Months
Using the Jamar Hand Dynamometer, the amount of pressure placed when squeezing the instrument as hard as possible was measured. Two trials per hand were measured. Change in hand grip was calculated by subtracting the highest value at 6 months from the highest value at baseline.
Measured: Baseline and 6 months
Change in Minimal Waist Circumference at 3 Months
Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 3 months from the measurement at baseline.
Measured: Baseline and 3 months
Change in Minimal Waist Circumference at 6 Months
Minimal waist circumference was measured at smallest horizontal circumference above umbilicus and below xiphoid process. Change in minimal waist circumference was calculated by subtracting the measurement at 6 months from the measurement at baseline.
Measured: Baseline and 6 months
Change in Body Composition: Percent Lean Mass at 3 Months
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. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 3 months from the percent lean mass at baseline.
Measured: Baseline and 3 months
Change in Body Composition: Percent Lean Mass at 6 Months
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. Percent lean mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent lean mass was calculated by subtracting the percent lean mass at 6 months from the percent lean mass at baseline.
Measured: Baseline and 6 months
Change in Body Composition: Percent Fat Mass at 3 Months
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. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 3 months from the percent fat mass at baseline.
Measured: Baseline and 3 months
Change in Body Composition: Percent Fat Mass at 6 Months
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. Percent fat mass was calculated by the BodPod machine and entered into a REDCap database. Then, change in percent fat mass was calculated by subtracting the percent fat mass at 6 months from the percent fat mass at baseline.
Measured: Baseline and 6 months
Mini-Cog at Baseline Only
To assess for cognitive impairment, the mini cog was used to screen for eligibility at baseline only. The mini cog includes two components - a 3-item recall and a clock drawing. You can score 0-3 points for the 3-item recall, and 0-2 points for the clock drawing. These subscale scores are summed for a total possible score of 5. Subscale scores were not reported, only the total score. The total score is a range of 0-5. The max total score is 5 with 5 being the best score. To be eligible for the study, the total item recall and clock score needed to be 3 or higher.
Measured: Baseline only
Change in Computerized Axial Tomography (CAT) Scan at 3 Months
Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 3 months from area at baseline.
Measured: Baseline and 3 months
Change in Computerized Axial Tomography (CAT) Scan at 6 Months
Cross sectional area of the thigh to determine thigh muscle mass. Change in area calculated by subtracting area at 6 Months from area at baseline.
Measured: Baseline and 6 months
Change in Short Form-36 (SF-36) Health Survey at 3 Months
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. Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Short Form-36 (SF-36) Health Survey at 6 Months
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. Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Profile of Mood States (POMS) at 3 Months
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). Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Profile of Mood States (POMS) at 6 Months
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). Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months
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). Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months
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). Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Perceived Stress Scale (PSS) at 3 Months
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.
Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Perceived Stress Scale (PSS) at 6 Months
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.
Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months
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.
Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months
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. Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Satisfaction With Life Scale (SWLS) at 3 Months
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. Change in score calculated by subtracting score at 3 months from score at baseline.
Measured: Baseline and 3 months
Change in Satisfaction With Life Scale (SWLS) at 6 Months
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. Change in score calculated by subtracting score at 6 months from score at baseline.
Measured: Baseline and 6 months
Change in Hemoglobin A1c at 3 Months
Blood assay (LabCorp). Change in value calculated by subtracting value at 3 months from value at baseline.
Measured: Baseline and 3 months
Change in Hemoglobin A1c at 6 Months
Blood assay (LabCorp). Change in value calculated by subtracting value at 6 months from value at baseline.
Measured: Baseline and 6 months
Change in Fear of Falling at 3 Months
"Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 3 months. Change was calculated by subtracting the number of "yes" answers at 3 months from the number of "yes" answers at baseline.
Measured: Baseline and 3 months
Change in Fear of Falling at 6 Months
"Yes" responses to the question, "Do you have a fear of falling?" Change in number of "yes" answers from baseline to 6 months. Change was calculated by subtracting the number of "yes" answers at 6 months from the number of "yes" answers at baseline.
Measured: Baseline and 6 months
Change in Number of Falls at 3 Months
This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 3 months from value at baseline.
Measured: Baseline and 3 months
Change in Number of Falls at 6 Months
This is an open-ended questionnaire to see the change in number of times a person falls between time points. Change in value calculated by subtracting value at 6 months from value at baseline.
Measured: Baseline and 6 months
Change in 3-day Diet Record, Calories, at 3 Months
3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 3 months from average daily calories at baseline.
Measured: Baseline and 3 months
Change in 3-day Diet Record, Calories, at 6 Months
3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in calories calculated by subtracting average daily calories at 6 months from average daily calories at baseline.
Measured: Baseline and 6 months
Change in 3-day Diet Record, Protein, at 3 Months
3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 3 months from average daily protein in grams at baseline.
Measured: Baseline and 3 months
Change in 3-day Diet Record, Protein, at 6 Months
3-day diet record by multiple pass; analyzed Food Processor (Version 10.13, 2013; ESHA Research). Change in protein in grams calculated by subtracting average daily protein in grams at 6 months from average daily protein in grams at baseline.
Measured: Baseline and 6 months
Number of Participants Measured Using an Axis Accelerometer (Actigraph)
Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at baseline.
Measured: Baseline
Number of Participants Measured Using an Axis Accelerometer (Actigraph)
Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 3 months.
Measured: 3 months
Number of Participants Measured Using an Axis Accelerometer (Actigraph)
Actigraph WGT3X-BT is a wearable accelerometer that measures activity counts, step counts, and physical activity intensity. This outcome is the number of participants who participated in this measurement at 6 months.
Measured: 6 months
Change in Glucose Tolerance Test (OGTT) (78-80), Blood
Ingestion of a 75 g glucose load
Measured: 3 months
Change in Glucose Tolerance Test (OGTT) (78-80), Blood
Ingestion of a 75 g glucose load
Measured: 6 months
Percent Attendance at Weekly Diet Class Between Baseline and 3 Months
Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100.
Measured: Baseline and 3 months
Percent Attendance at Weekly Diet Class Between Baseline and 6 Months
Attendance counted if in person or virtual. Percentage calculated by dividing number of classes attended by number of classes held and multiplying by 100.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start12 Dec 2019
- Primary completion26 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Connie W Bales, PhD RD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835416
- Sponsor's protocol ID
- E2843-R
- Acronym
- VALOR-UP
- Status last verified
- May 2025
- First submitted
- 29 Jan 2019
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bales CW, Miller MG, McDonald SR, Wallis JT, Yeager LA, Sloane RJ, Porter Starr KN. Influence of Protein Intake during Obesity Reduction on Physical Function and Body Habitus in Older Males with Prediabetes: A Pilot Study. Curr Dev Nutr. 2026 Jul 25;10(9):109460. doi: 10.1016/j.cdnut.2026.109460. eCollection 2026 Sep.
PubMed 42701496
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Protein Intake During Obesity Reduction in Older Male Veterans: Differences in Physical Function and Muscle Quality Responses by Race
- ClinicalTrials.gov ID
- NCT03835416
- Acronym / sponsor ID
- VALOR-UP / E2843-R
- Conditions
- Prediabetes, Obesity
- Keywords
- obesity, prediabetic state, older person, diet, reducing, protein, muscle function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| WL-Control | Experimental | Dietary Supplement: Foods rich in high quality protein0.8 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. |
| WL-Protein | Experimental | Dietary Supplement: Foods rich in high quality protein>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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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%
Key exclusion criteria (15 listed)
- Presence of unstable or symptomatic life-threatening illness
- Glomerular filtration rates (GFR) less than 45 mL/min
- Mini Cog score of <3
- --Vegetarian
- Neurological conditions causing functional impairments, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foods rich in high quality proteinAlong 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). | Dietary supplement | WL-Control, WL-Protein |
Primary outcome
Total Short Physical Performance Battery (SPPB) Score at Baseline
Time frame: 0 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.
Change in Total Short Physical Performance Battery (SPPB) Score at 3 Months
Time frame: Baseline and 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.
Change in Total Short Physical Performance Battery (SPPB) Score at 6 Months
Time frame: Baseline and 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.
50 secondary outcomes
Percent Change in Body Weight at 3 Months
Time frame: Baseline and 3 months
Percent Change in Body Weight at 6 Months
Time frame: Baseline and 6 months
Change in 6 Minute Walk Test (Aerobic Endurance) at 3 Months
Time frame: Baseline and 3 months
Change in 6 Minute Walk Test (Aerobic Endurance) at 6 Months
Time frame: 6 months
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 3 Months
Time frame: Baseline and 3 months
Change in Timed 8-ft Up and Go (Agility/Dynamic Balance) at 6 Months
Time frame: Baseline and 6 months
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 3 Months
Time frame: Baseline and 3 months
Change in Number of Chair Stands in 30 Seconds (Lower Body Strength) at 6 Months
Time frame: Baseline and 6 months
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 3 Months
Time frame: Baseline and 3 months
Change in Isokinetic Knee Extension Peak Torque (Muscle Strength) at 6 Months
Time frame: Baseline and 6 months
Change in Isometric Hand Grip (Upper Body Strength) at 3 Months
Time frame: Baseline and 3 months
Change in Isometric Hand Grip (Upper Body Strength) at 6 Months
Time frame: Baseline and 6 months
Change in Minimal Waist Circumference at 3 Months
Time frame: Baseline and 3 months
Change in Minimal Waist Circumference at 6 Months
Time frame: Baseline and 6 months
Change in Body Composition: Percent Lean Mass at 3 Months
Time frame: Baseline and 3 months
Change in Body Composition: Percent Lean Mass at 6 Months
Time frame: Baseline and 6 months
Change in Body Composition: Percent Fat Mass at 3 Months
Time frame: Baseline and 3 months
Change in Body Composition: Percent Fat Mass at 6 Months
Time frame: Baseline and 6 months
Mini-Cog at Baseline Only
Time frame: Baseline only
Change in Computerized Axial Tomography (CAT) Scan at 3 Months
Time frame: Baseline and 3 months
Change in Computerized Axial Tomography (CAT) Scan at 6 Months
Time frame: Baseline and 6 months
Change in Short Form-36 (SF-36) Health Survey at 3 Months
Time frame: Baseline and 3 months
Change in Short Form-36 (SF-36) Health Survey at 6 Months
Time frame: Baseline and 6 months
Change in Profile of Mood States (POMS) at 3 Months
Time frame: Baseline and 3 months
Change in Profile of Mood States (POMS) at 6 Months
Time frame: Baseline and 6 months
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 3 Months
Time frame: Baseline and 3 months
Change in Center for Epidemiologic Studies Depression Scale (CES-D) at 6 Months
Time frame: Baseline and 6 months
Change in Perceived Stress Scale (PSS) at 3 Months
Time frame: Baseline and 3 months
Change in Perceived Stress Scale (PSS) at 6 Months
Time frame: Baseline and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI) and 3 Months
Time frame: Baseline and 3 months
Change in Pittsburgh Sleep Quality Index (PSQI) and 6 Months
Time frame: Baseline and 6 months
Change in Satisfaction With Life Scale (SWLS) at 3 Months
Time frame: Baseline and 3 months
Change in Satisfaction With Life Scale (SWLS) at 6 Months
Time frame: Baseline and 6 months
Change in Hemoglobin A1c at 3 Months
Time frame: Baseline and 3 months
Change in Hemoglobin A1c at 6 Months
Time frame: Baseline and 6 months
Change in Fear of Falling at 3 Months
Time frame: Baseline and 3 months
Change in Fear of Falling at 6 Months
Time frame: Baseline and 6 months
Change in Number of Falls at 3 Months
Time frame: Baseline and 3 months
Change in Number of Falls at 6 Months
Time frame: Baseline and 6 months
Change in 3-day Diet Record, Calories, at 3 Months
Time frame: Baseline and 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42701496Bales CW, Miller MG, McDonald SR, Wallis JT, Yeager LA, Sloane RJ, Porter Starr KN. Influence of Protein Intake during Obesity Reduction on Physical Function and Body Habitus in Older Males with Prediabetes: A Pilot Study. Curr Dev Nutr. 2026 Jul 25;10(9):109460. doi: 10.1016/j.cdnut.2026.109460. eCollection 2026 Sep.
- Individual participant dataSharing planned: No
Related trials for Prediabetes
Active, not recruiting
Metabolic and Inflammatory Outcomes of the Ketogenic Diet Comparing Saturated and Unsaturated Fat Sources
PreDiabetes, Diabetes Mellitus, Type 2
Active, not recruitingEarly Phase 1
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Prostate Cancer
Not yet recruitingPhase 4
Effect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance
MAFLD in Prediabetes and Diabetes
Not yet recruiting
Trial of CGM Technology in Persons Living With Prediabetes
Prediabetes
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie W Bales, PhD RD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foods rich in high quality protein in people with Prediabetes and Obesity, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Short Physical Performance Battery (SPPB) Score at Baseline (time frame: 0 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03835416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.