All > Prediabetes

Foods rich in high quality protein for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Durham VA Medical Center, Durham, NC, Durham, NCObesity+1 MoreFoods rich in high quality protein - DietarySupplement
Eligibility
18+
Male
What conditions do you have?
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Study 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.

Eligible Conditions
  • Obesity
  • Prediabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 23 Secondary · Reporting Duration: 0,1,2,3,4,5,6 months

Month 6
Change in 6 Minutes Walk Test (aerobic endurance)
Change in Body Weight
0, 3, 6 months
Change in Glucose Tolerance Test (OGTT) (78-80), blood
Change in Metabolic Panel (LabCorp)- A Blood Draw and testing
Change in Short Physical Performance Battery (SPPB)
Change in number of falls and fear of falling
Month 6
Change in Actigraph, Axis accelerometer (activity counts, step counts, physical activity intensity)
Month 12
Change in Center for Epidemiologic Studies Depression Scale (CES-D)
Change in Perceived Stress Scale (PSS)
Change in Pittsburgh Sleep Quality Index (PSQI)
Change in Profile of Mood States (POMS)
Change in Satisfaction with Life Scale (SWLS)
Change in Short Form-36 (SF-36) Health Survey
0, 3, 6, [9, 12] months
Change in 3-day diet record
Month 6
Change in 30 second chair stands (lower body strength)
Change in Body Composition: BodPod
Change in Computerized Axial Tomography (CAT) scan
Change in Isokinetic knee extension peak torque (muscle strength)
Change in Isometric hand grip (upper body strength)
Change in Minimal Waist Circumference
0,1,2,3,4,5,6 months
Change in Protein Checklist Form
0,3, and 6 months
Change in 8-ft Up and Go (agility/dynamic balance)
Baseline
Mini-Cog
Week 36
Change in Daily food journal (Adherence)

Trial Safety

Safety Progress

1 of 3

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1
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1
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Trial Design

2 Treatment Groups

WL-Control
1 of 2
WL-Protein
1 of 2

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: Foods rich in high quality protein · No Placebo Group · N/A

WL-Control
DietarySupplement
Experimental Group · 1 Intervention: Foods rich in high quality protein · Intervention Types: DietarySupplement
WL-Protein
DietarySupplement
Experimental Group · 1 Intervention: Foods rich in high quality protein · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0,1,2,3,4,5,6 months

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,494 Previous Clinical Trials
2,724,074 Total Patients Enrolled
38 Trials studying Obesity
9,959 Patients Enrolled for Obesity
Connie W Bales, PhD RDPrincipal InvestigatorDurham VA Medical Center, Durham, NC

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study is only open to male veterans.
Your physical performance score is between 4 and 10 units on a specific test.
You are considered medically obese with a body mass index (BMI) over 30 kg/m2.
Participants of African American or Caucasian ethnicity.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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