← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after bariatric surgery

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have had a Roux-en-Y gastric bypass or sleeve gastrectomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after bariatric surgery

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lean body mass

Muscle mass

Total energy expenditure

Secondary outcome measures

Diet induced thermogenesis

Dietary intake (Objective)

Essential amino acids

+12 more

Other outcome measures

Dietary Intake (Subjective)

Physical activity (Subjective)

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor

973 Previous Clinical Trials

6,845,989 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

2,356 Previous Clinical Trials

4,315,026 Total Patients Enrolled

101 Trials studying Weight Loss

18,967 Patients Enrolled for Weight Loss

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

Frequently Asked Questions

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

To what extent has this research been populated by participants?

"Affirmative. The data on clinicaltrials.gov evidences that this trial, which was originally posted on March 9th 2021, is actively recruiting patients for participation. Forty participants need to be recruiter from a single medical centre."

Answered by AI

Is enrollment still possible for this clinical experiment?

"This clinical trial is recruiting 40 individuals with a BMI greater than 18 and less than 60. The most crucial requirements include an eagerness to undergo bariatric surgery, either Roux-en-Y gastric bypass or sleeve gastrectomy, as well as the lack of any disqualifying factors."

Answered by AI

Is this clinical trial open to geriatric participants?

"To meet the criteria to join this experiment, applicants must be aged 18 to 60. Conversely there are separate clinical trials that accept minors and those over 65 years of age with a total of 189 studies available for both groups."

Answered by AI

Are there vacancies left in this clinical trial?

"Yes, the information found on clinicaltrials.gov reveals that this medical investigation is actively seeking volunteers. It was initially created on March 9th 2021 and its most recent update occurred on September 21st 2022. A total of 40 participants will be needed from only one site."

Answered by AI

What is the main purpose of this clinical trial?

"The key metric to be monitored over a 6 month period following bariatric surgery is lean body mass. Other variables of interest include diet induced thermogenesis, blood glucose levels expressed in milligrams per deciliter, and subcutaneous fat mass in kilograms."

Answered by AI