Absorption Comparison on Equivalency Value of Genepro Gen2

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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

Participant Flow

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
Arm/Group Description	1 tablespoon Serving of Genepro Gen...	30g Serving of Whey Isolate Protein...
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

Baseline Characteristics

Arm/Group Title		All Participants
Arm/Group Description		All participants were given a basel...
Arm/Group Description		All participants were given a baseline blood analysis
Overall Number of Baseline Participants		20
Baseline Analysis Population Description		...
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
United States		20
Protein blood levels ^[1] Mean (Standard Deviation) Unit of measure: G/dl
Genepro Gen2 first	Number Analyzed	10 participants
Genepro Gen2 first		7.1 (.4)
Whey Isolate first	Number Analyzed	10 participants
Whey Isolate first		6.9 (.4)
All Participants	Number Analyzed	20 participants
All Participants		7.0 (.4)
		[1] Measure Analysis Population Description: Participants assessed separately for each sequence.

Outcome Measures

1.Primary Outcome


Title	Weekly Blood Draws to Measure Blood Protein Levels
Description	Each week the 20 participants will have blood drawn to measure their b...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Genepro Gen2 Protein	Whey Protein Isolate
Arm/Group Description:	1 tablespoon Serving of Genepro Gen...	30g Serving of Whey Isolate Protein...
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	No adverse events were monitored

Arm/Group Title	Genepro Gen2 Protein	Whey Protein Isolate
Arm/Group Description	1 tablespoon Serving of Genepro Gen...	30g Serving of Whey Isolate Protein...
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	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Genepro Gen2 Protein	Whey Protein Isolate
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
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

Limitations and Caveats

[Not Specified]

More Information

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

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