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High-Protein Diet for Obesity (VALOR-UP Trial)
N/A
Waitlist Available
Led By Connie W Bales, PhD RD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 55+ years
Pre-diabetes (confirmed fasting plasma glucose 100 and <126 mg/dL) or HbA1c 5.7-6.4%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0,1,2,3,4,5,6 months
Awards & highlights
VALOR-UP Trial Summary
This trial is testing whether a higher-protein diet can help obese, older Veterans with diabetes improve their physical function. The study will compare the effects of the diet on white and black participants.
Who is the study for?
This trial is for obese male Veterans aged 55+ with prediabetes, who are either African American or Caucasian. They must have a BMI over 30, normal kidney function, and be able to track their diet (or have someone who can). Participants should also have some physical limitations but still be capable of certain activities.Check my eligibility
What is being tested?
The study compares two diets: one high in quality protein aimed at improving physical function versus a standard protein intake based on the Recommended Dietary Allowance. The main goal is to see which diet better enhances muscle performance and overall health in these Veterans.See study design
What are the potential side effects?
While not explicitly stated, potential side effects may include digestive changes due to dietary adjustments. High-protein diets sometimes lead to increased bowel movements, gas, or constipation.
VALOR-UP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or older.
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My blood sugar or HbA1c levels indicate I have pre-diabetes.
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My BMI is over 30.
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I am a male veteran.
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My physical ability score is between 4 and 10.
VALOR-UP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0,1,2,3,4,5,6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0,1,2,3,4,5,6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Short Physical Performance Battery (SPPB)
Secondary outcome measures
Change in 3-day diet record
Change in 30 second chair stands (lower body strength)
Change in 6 Minutes Walk Test (aerobic endurance)
+20 moreVALOR-UP Trial Design
2Treatment groups
Experimental Treatment
Group I: WL-ProteinExperimental Treatment1 Intervention
>30 g of high quality protein per meal, 1.2 g protein/kg body weight/day. Fourteen servings of high quality (30 g/serving) protein (lean meats, low fat dairy products) provided to participants each week to increase compliance.
Group II: WL-ControlExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Foods rich in high quality protein
2019
N/A
~110
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,301 Total Patients Enrolled
40 Trials studying Obesity
9,942 Patients Enrolled for Obesity
Connie W Bales, PhD RDPrincipal InvestigatorDurham VA Medical Center, Durham, NC
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is moderately reduced, needing tests every two months.I have a severe illness that is getting worse or causing symptoms.I have a neurological condition like Parkinson's, MS, or disability from a stroke.You follow a vegetarian diet.I am 55 years old or older.My memory and thinking test score is less than 3.I am not using drugs that are not allowed in the study and do not abuse substances.My kidney function is reduced, with a GFR under 45 mL/min.My blood sugar or HbA1c levels indicate I have pre-diabetes.I am willing and able to follow any treatment plan I am assigned.I cannot complete physical function tests.My primary care doctor does not agree with me joining this study.My BMI is over 30.You have a mental health condition or personality disorder that would make it difficult for you to participate in a group intervention program.My kidney function is normal or mildly reduced.I am a male veteran.My physical ability score is between 4 and 10.My kidney function is normal for my age.My weight has changed a lot recently.Participants of African American or Caucasian ethnicity.
Research Study Groups:
This trial has the following groups:- Group 1: WL-Control
- Group 2: WL-Protein
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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