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Amino Acid-based Nutritional Formulation

Amino Acid Supplements for Weight Loss After Bariatric Surgery

N/A
Recruiting
Led By Nancy Puzziferri, MD MSCS
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Roux-en-Y gastric bypass or sleeve gastrectomy
Be between 18 and 65 years old
Must not have
Cardiac disease such as Left Ventricular Assist Device requirement
Refusal to consume study formula
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after bariatric surgery
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether an amino acid supplement can help people who have had bariatric surgery to lose fat and maintain muscle mass.

Who is the study for?
This trial is for individuals planning to undergo bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) and who are not over 450 pounds. It's not suitable for those with renal failure, liver disease, uncontrolled diabetes, cardiac disease, or pregnant women. Participants must be willing to consume the study formula.
What is being tested?
The trial is examining if a nutritional supplement rich in Essential Amino Acids can help maintain muscle mass while promoting fat loss after bariatric surgery. The focus is on whether this supplement affects the body's protein synthesis and metabolic rate post-surgery.
What are the potential side effects?
While specific side effects are not detailed here, potential risks may include digestive discomfort from the protein supplement or allergic reactions to its ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a Roux-en-Y gastric bypass or sleeve gastrectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need a device to help my heart pump blood.
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I refuse to take the study's specific formula.
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I am on dialysis for kidney failure.
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My liver is not functioning well, indicated by high bilirubin or a high Fibrosis-4 score.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after bariatric surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after bariatric surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Lean body mass
Muscle mass
Total energy expenditure
Secondary study objectives
Diet induced thermogenesis
Dietary intake (Objective)
Essential amino acids
+12 more
Other study objectives
Dietary Intake (Subjective)
Physical activity (Subjective)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Proprietary Essential Amino Acid Protein SupplementExperimental Treatment1 Intervention
Essential amino acid protein supplement; 15 grams (one packet) dissolved in 8 ounces of water twice daily for 6 months.
Group II: Commercially-available whey protein supplement - Beneprotein®Active Control1 Intervention
Beneprotein® whey protein supplement; 15 grams (one packet) dissolved in 8 ounces of water twice daily for 6 months.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,414,072 Total Patients Enrolled
2 Trials studying Weight Loss
210 Patients Enrolled for Weight Loss
The Amino Company, LLCUNKNOWN
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,455 Previous Clinical Trials
4,335,068 Total Patients Enrolled
103 Trials studying Weight Loss
19,177 Patients Enrolled for Weight Loss
Nancy Puzziferri, MD MSCSPrincipal InvestigatorOregon Health and Science University

Media Library

Beneprotein® (Amino Acid-based Nutritional Formulation) Clinical Trial Eligibility Overview. Trial Name: NCT04751916 — N/A
Weight Loss Research Study Groups: Proprietary Essential Amino Acid Protein Supplement, Commercially-available whey protein supplement - Beneprotein®
Weight Loss Clinical Trial 2023: Beneprotein® Highlights & Side Effects. Trial Name: NCT04751916 — N/A
Beneprotein® (Amino Acid-based Nutritional Formulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04751916 — N/A
~8 spots leftby Dec 2025
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