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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~0,1,2,3,4,5,6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0,1,2,3,4,5,6 months for reporting.

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 more

VALOR-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
1,609 Previous Clinical Trials
3,306,498 Total Patients Enrolled
40 Trials studying Obesity
9,982 Patients Enrolled for Obesity
Connie W Bales, PhD RDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Media Library

Foods rich in high quality protein (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03835416 — N/A
Obesity Research Study Groups: WL-Control, WL-Protein
Obesity Clinical Trial 2023: Foods rich in high quality protein Highlights & Side Effects. Trial Name: NCT03835416 — N/A
Foods rich in high quality protein (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835416 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is this trial enrolling participants?

"Correct. According to the data hosted on clinicaltrials.gov, this medical trial is currently in search of participants and was first published on November 15th 2019. The study wishes to enrol 240 patients from one location with its last edit being made April 20th 2022."

Answered by AI

Are individuals still able to enroll in this clinical experiment?

"According to the clinicaltrials.gov database, this research project is actively searching for participants and has been since November 15th 2019; it was last updated on April 20th 2022."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Ive been overweight and considered obese for nearly my entire life. The highest I've ever been is about 280-290lbs. during pregnancy 2020. Since then the weight has been even harder to remove, I have a basic lazy diet. Coffee, water, carbs and dairy. I'm more of a drinker than eater. So drinking multiple cups of coffee a day is easy. We're talking 3-5cups a day. But have a routinely active daily schedule. I grab handfuls of nuts during the day or rice crackers.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein
2019. "Veterans Achieving Weight Loss and Optimizing Resilience-Using Protein". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03835416.
~19 spots leftby Apr 2025
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