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Absorption Comparison on Equivalency Value of Genepro Gen2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02919657
Recruitment Status : Completed
First Posted : September 29, 2016
Results First Posted : December 1, 2016
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Musclegen Research, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Analysis, Event History
Absorption; Disorder, Protein
Interventions Dietary Supplement: Genepro Protein
Dietary Supplement: Whey Protein
Enrollment 20
Recruitment Details Open call for bariatric patients via social media and direct mail marketing.
Pre-assignment Details  
Arm/Group Title Genepro Gen2 Protein Then Whey Protein Whey Protein Isolate Then Genepro Gen2 Protein
Hide Arm/Group Description

1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.

30g Serving of Whey Isolate Protein will be used daily in each subject.

30g Serving of Whey Isolate Protein will be used daily in each subject.

1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.

Period Title: Overall Study
Started 10 [1] 10 [1]
Completed 10 [2] 10 [2]
Not Completed 0 0
[1]
10 Participants
[2]
completed with the same initial 10 participants
Arm/Group Title All Participants
Hide Arm/Group Description All participants were given a baseline blood analysis
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
20 Post Op Gastric Bypass patients. 10 men, 10 women. All participants were between the ages of 30-46 years of age. All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
39  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
10
  50.0%
Male
10
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
Protein blood levels   [1] 
Mean (Standard Deviation)
Unit of measure:  G/dl
Genepro Gen2 first Number Analyzed 10 participants
7.1  (.4)
Whey Isolate first Number Analyzed 10 participants
6.9  (.4)
All Participants Number Analyzed 20 participants
7.0  (.4)
[1]
Measure Analysis Population Description: Participants assessed separately for each sequence.
1.Primary Outcome
Title Weekly Blood Draws to Measure Blood Protein Levels
Hide Description

Each week the 20 participants will have blood drawn to measure their blood protein levels.

Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable.

10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6.

10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6.

These measurements will read in g/dl

Time Frame 6 weeks per intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Genepro Gen2 Protein Whey Protein Isolate
Hide Arm/Group Description:

1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.

Intervention: Weekly blood draws will determine the effect on blood protein levels.

Genepro Protein: weekly blood draws to measure blood protein levels

30g Serving of Whey Isolate Protein will be used daily in each subject.

Intervention: Weekly blood draws will determine the effect on blood protein levels.

Whey Protein: weekly blood draws to measure blood protein levels

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: grams per deciliter
Female Age 37 7.23  (.4) 6.86  (.4)
Male Age 34 7.43  (.7) 7.21  (.3)
Male Age 30 7.1  (.5) 7.28  (.2)
Female Age 32 7.16  (.3) 6.95  (.1)
Female Age 40 7.2  (.3) 6.86  (.2)
Male Age 40 7.11  (.8) 6.08  (1.1)
Male B Age 34 7.05  (.6) 6.95  (.5)
Female Age 34 6.6  (.2) 6.46  (.3)
Female B Age 37 6.55  (.2) 6.65  (.2)
Male Age 39 7.18  (1.1) 6.88  (.3)
Female Age 30 6.81  (.5) 6.58  (.2)
Male Age 46 6.81  (.5) 6.58  (.2)
Female Age 39 6.76  (.3) 6.03  (.5)
Male Age 36 6.81  (.5) 6.48  (.2)
Female B Age 32 6.88  (.6) 6.26  (.4)
Male Age 38 7.18  (.5) 6.83  (.8)
Female Age 36 6.73  (.9) 6.31  (.4)
Male C Age 34 7.13  (.4) 7  (.4)
Female B Age 36 6.13  (.8) 6  (.8)
Male Age 41 7  (.5) 6.95  (.3)
Time Frame [Not Specified]
Adverse Event Reporting Description No adverse events were monitored
 
Arm/Group Title Genepro Gen2 Protein Whey Protein Isolate
Hide Arm/Group Description

1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.

Intervention: Weekly blood draws will determine the effect on blood protein levels.

Genepro Protein: weekly blood draws to measure blood protein levels

30g Serving of Whey Isolate Protein will be used daily in each subject.

Intervention: Weekly blood draws will determine the effect on blood protein levels.

Whey Protein: weekly blood draws to measure blood protein levels

All-Cause Mortality
Genepro Gen2 Protein Whey Protein Isolate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Genepro Gen2 Protein Whey Protein Isolate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Genepro Gen2 Protein Whey Protein Isolate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Michael
Organization: Medfit Rx
Phone: 9196109893
EMail: dmichael@medfitrx.net
Layout table for additonal information
Responsible Party: Musclegen Research, Inc.
ClinicalTrials.gov Identifier: NCT02919657    
Other Study ID Numbers: Genepro Gen 2
First Submitted: September 19, 2016
First Posted: September 29, 2016
Results First Submitted: October 4, 2016
Results First Posted: December 1, 2016
Last Update Posted: April 24, 2017