Genepro Generation 3 Bioavailability Compared to Whey Protein (12g Genepro vs 30g Whey)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Blood Protein Levels
Study Overview
Brief Summary
Objective of Clinical Trial: To test, in a blinded study the bioavailability of Genepro Generation 3 (GEN3) Protein as compared to whey protein. This study is intended to show the equivalent value of Genepro Gen3 as compared to whey protein (1scoop (12g) Genepro Generation 3 (GEN3) compared to 30g serving of whey protein). Total Serum Protein levels will be tested every other week to evaluate blood protein levels in each participant
Detailed Description
Detailed Description:
Condition or Disease: Analysis, Event History. Absorption; Disorder, protein
Objective of Clinical Trial: To test, in a blinded study the bioavailability of Genepro Generation 3 (GEN3) Protein as compared to whey protein. This study is intended to show the equivalent value of Genepro Gen3 as compared to whey protein (1scoop (12g) Genepro Generation 3 (GEN3) compared to 30g serving of whey protein). Total Serum Protein levels will be tested every other week to evaluate blood protein levels in each participant.
Parameters: This study encompasses a 6-week program that follows 40 gastric bypass patients that have undergone weight loss surgery. We will establish a baseline blood analysis prior to the start of the study and subsequently we will take bi-weekly blood work to chart and register the findings (weeks 2, 4 and 6). For this study we will only be doing the bi-weekly analysis on blood protein levels by utilizing Spectrophotometry with total serum protein. The target blood protein range is 6.1-8.7 g/dL this test is administered without fasting.
Participants: 40 Post Op Gastric Bypass patients. 20 men, 20 women. All participants were between the ages of 25-80 years of age. All participants have been post operation from their weight loss surgery for a minimum of 6 months prior to the start of the study and no longer than 8 months at the start of the study. Participants will be randomly selected, blindly, by the study sponsor. The selection will utilize participants files with names and ethnicity removed. Selection will be randomized into Group A and Group B. One group will be assigned Genepro while the other group will be assigned a leading whey protein powder. Participants will be assigned a Identification Code/Number for the duration of the study. Results will be posted using this identification number as well as stating the age and gender of the participant. Participant names will be held in confidence. Participants must maintain a daily log that will be shared with study investigators. This log will contain daily lists of food and beverage consumed as well as personal thoughts on taste and ease of use of protein supplements as well as a daily synopsis of overall general emotional and physical feelings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Masking Description
Active Comparator: Genepro Gen2 Protein 11g Serving of Genepro Gen3 Protein daily will be used in each subject. Intervention: Bi-Weekly blood draws will determine the effect on blood protein levels.
Active Comparator: Whey Protein Isolate 30g Serving of Whey Protein will be used daily in each subject. Intervention:Bi-Weekly blood draws will determine the effect on blood protein levels.
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants will be solicited to volunteer through WakeMed Bariatric Surgery Center (current patients)
- •All participants must have normal blood protein levels prior to the study
- •All participants must be six months post op (bariatric surgery)
- •All participants must avoid any other protein supplementation during the trial period
- •All participants are required to maintain a daily nutrition log
- •All participants must have no milk/dairy allergies
- •Age Eligibility: 25 years to 80 years (Adult)
- •Sexes Eligibility for Study: ALL
- •Only Accepts Healthy Volunteers
Exclusion Criteria
- •No candidates with prior digestive distress disorders (IBS, Crones, etc.)
- •Participants with any negative GI score, they will be excluded from the study
- •Participants with abnormal blood protein levels at the time of study
- •Unhealthy Volunteers
- •Volunteers with compromised immune systems
- •Volunteers younger than 25 years of age
- •Volunteers older than 80 years of age
- •Allergies to milk or lactose
Outcomes
Primary Outcomes
Blood Protein Levels
Time Frame: 6 weeks
Each participant in each group will have blood protein levels checked via blood draw at a WakeMed facility (based on participants geographic location). The target blood protein range is 6.1-8.7 g/dL this test is administered without fasting.
Secondary Outcomes
No secondary outcomes reported