Essential Amino Acid Protein Supplement for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weight LossEssential Amino Acid Protein Supplement - DietarySupplement
Eligibility
18 - 60
All Sexes
What conditions do you have?
Select

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.

Treatment Effectiveness

Study Objectives

3 Primary · 15 Secondary · Reporting Duration: 6 months after bariatric surgery

Month 6
Diet induced thermogenesis
Dietary Intake (Subjective)
Dietary intake (Objective)
Essential amino acids
Glucose
Insulin
Lean body mass
Liver fat mass
Muscle mass
Muscle protein fractional synthetic rate
Muscle protein synthetic rate
Percent muscle fat
Physical activity (Objective)
Physical activity (Subjective)
Resting energy expenditure
Subcutaneous fat mass
Total energy expenditure
Visceral fat mass
Weight
Whole body fat mass

Trial Safety

Trial Design

2 Treatment Groups

Commercially-available whey protein supplement - Beneprotein®
1 of 2
Proprietary Essential Amino Acid Protein Supplement
1 of 2

Active Control

Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Essential Amino Acid Protein Supplement · No Placebo Group · N/A

Proprietary Essential Amino Acid Protein Supplement
DietarySupplement
Experimental Group · 1 Intervention: Essential Amino Acid Protein Supplement · Intervention Types: DietarySupplement
Commercially-available whey protein supplement - Beneprotein®
DietarySupplement
ActiveComparator Group · 1 Intervention: Beneprotein® · Intervention Types: DietarySupplement

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after bariatric surgery

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,142 Previous Clinical Trials
4,064,465 Total Patients Enrolled
90 Trials studying Weight Loss
17,560 Patients Enrolled for Weight Loss
The Amino Company, LLCUNKNOWN
Oregon Health and Science UniversityLead Sponsor
893 Previous Clinical Trials
6,829,334 Total Patients Enrolled
2 Trials studying Weight Loss
210 Patients Enrolled for Weight Loss
Nancy Puzziferri, MD MSCSPrincipal InvestigatorOregon Health and Science University

Eligibility Criteria

Age 18 - 60 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been evaluated by a bariatric surgeon and you have been determined to be a suitable candidate for bariatric surgery.
You have undergone a Roux-en-Y gastric bypass or sleeve gastrectomy.
You have no exclusion.

Who else is applying?

What state do they live in?
Missouri25.0%
Texas25.0%
California25.0%
Other25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Oregon Health and Science University100.0%
What portion of applicants met pre-screening criteria?
Met criteria25.0%
Did not meet criteria75.0%
References