Trial Outcomes & Findings for Absorption Comparison on Equivalency Value of Genepro Gen2 (NCT NCT02919657)
NCT ID: NCT02919657
Last Updated: 2017-04-24
Results Overview
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
COMPLETED
PHASE4
20 participants
6 weeks per intervention
2017-04-24
Participant Flow
Open call for bariatric patients via social media and direct mail marketing.
Participant milestones
| Measure |
Genepro Gen2 Protein Then Whey Protein
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.
|
Whey Protein Isolate Then Genepro Gen2 Protein
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants assessed separately for each sequence.
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
All participants were given a baseline blood analysis
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 1 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
|
Protein blood levels
Genepro Gen2 first
|
7.1 g/dl
STANDARD_DEVIATION .4 • n=10 Participants • Participants assessed separately for each sequence.
|
|
Protein blood levels
Whey Isolate first
|
6.9 g/dl
STANDARD_DEVIATION .4 • n=10 Participants • Participants assessed separately for each sequence.
|
|
Protein blood levels
All Participants
|
7.0 g/dl
STANDARD_DEVIATION .4 • n=20 Participants • Participants assessed separately for each sequence.
|
PRIMARY outcome
Timeframe: 6 weeks per interventionEach 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
Outcome measures
| Measure |
Genepro Gen2 Protein
n=20 Participants
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
|
Whey Protein Isolate
n=20 Participants
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
|
|---|---|---|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female B Age 32
|
6.88 grams per deciliter
Standard Deviation .6
|
6.26 grams per deciliter
Standard Deviation .4
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 30
|
7.1 grams per deciliter
Standard Deviation .5
|
7.28 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 32
|
7.16 grams per deciliter
Standard Deviation .3
|
6.95 grams per deciliter
Standard Deviation .1
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 40
|
7.2 grams per deciliter
Standard Deviation .3
|
6.86 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 40
|
7.11 grams per deciliter
Standard Deviation .8
|
6.08 grams per deciliter
Standard Deviation 1.1
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male B Age 34
|
7.05 grams per deciliter
Standard Deviation .6
|
6.95 grams per deciliter
Standard Deviation .5
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 34
|
6.6 grams per deciliter
Standard Deviation .2
|
6.46 grams per deciliter
Standard Deviation .3
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female B Age 37
|
6.55 grams per deciliter
Standard Deviation .2
|
6.65 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 30
|
6.81 grams per deciliter
Standard Deviation .5
|
6.58 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 46
|
6.81 grams per deciliter
Standard Deviation .5
|
6.58 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 39
|
6.76 grams per deciliter
Standard Deviation .3
|
6.03 grams per deciliter
Standard Deviation .5
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 36
|
6.81 grams per deciliter
Standard Deviation .5
|
6.48 grams per deciliter
Standard Deviation .2
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 38
|
7.18 grams per deciliter
Standard Deviation .5
|
6.83 grams per deciliter
Standard Deviation .8
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 36
|
6.73 grams per deciliter
Standard Deviation .9
|
6.31 grams per deciliter
Standard Deviation .4
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male C Age 34
|
7.13 grams per deciliter
Standard Deviation .4
|
7 grams per deciliter
Standard Deviation .4
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female B Age 36
|
6.13 grams per deciliter
Standard Deviation .8
|
6 grams per deciliter
Standard Deviation .8
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 41
|
7 grams per deciliter
Standard Deviation .5
|
6.95 grams per deciliter
Standard Deviation .3
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Female Age 37
|
7.23 grams per deciliter
Standard Deviation .4
|
6.86 grams per deciliter
Standard Deviation .4
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 34
|
7.43 grams per deciliter
Standard Deviation .7
|
7.21 grams per deciliter
Standard Deviation .3
|
|
Weekly Blood Draws to Measure Blood Protein Levels
Male Age 39
|
7.18 grams per deciliter
Standard Deviation 1.1
|
6.88 grams per deciliter
Standard Deviation .3
|
Adverse Events
Genepro Gen2 Protein
Whey Protein Isolate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER