Analysis, Event HistoryPhase 4NCT02919657
Absorption Comparison on Equivalency Value of Genepro Gen2
A Phase 4 study testing Genepro Protein and Whey Protein in people with Analysis, Event History and Absorption; Disorder, Protein, run by Musclegen Research, Inc..
Trial summary
Genepro Gen2 Absorption and Protein Value Clinical Trial. Read more about this study
- Who is it for?
- Ages 30 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Analysis, Event History, Absorption; Disorder, Protein
- What is being tested?
- Genepro Protein and Whey Protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Any digestive distress disorder (IBS, Crones, etc).
About this study
Official title: Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.
Genepro Gen2 Absorption and Protein Value Clinical Trial.
Read the detailed description
Objective: To prove the absorbability and usability of Genepro Gen2 Protein and compared to whey isolate. This study is intended to show the equivalent value of Genepro Gen2 as compared to whey protein isolate (1 tablespoon Genepro Gen2 compared to 30g serving of whey isolate)
Parameters: This study encompasses a 12-week program that follows 20 gastric bypass patients that have undergone weight loss surgery. We took a baseline blood analysis prior to the start of the study and subsequently we took weekly blood work to chart and register the findings. For this study we will only be doing the weekly analysis on blood protein levels by utilizing Spectrophotometry. The target blood protein range is 6.1-8.7 g/dL this test is administered while fasting.
Participants: 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.
Gathering Results: 10 subjects will receive Genepro Gen 2 protein (1 tablespoon serving) for the first 6 weeks of the study and for the last six weeks, they will receive 30g of Whey protein. In conjunction the other group of 10 subjects will receive 30g whey protein the first 6 weeks of the study and Genepro Gen2 protein the final six weeks. Weekly blood analysis will determine blood protein levels.
Diet: Diet guidelines limit the calories you consume while providing you with balanced meals to help prevent nutritional deficiencies and preserve your muscle tissue. Each patient tolerates suggested foods differently.
Daily calories should be between 600 to 700 for the duration of this study. Each subject is to follow a diet low in calories, fats and sweets. The goal for each subject is to consume a minimum of 65 to 75 grams of protein a day. High protein foods include eggs, meats, fish, seafood, tuna, poultry, tofu, milk, soy, cottage cheese, and yogurt. 30g of each daily intake of protein will be provided by a powdered protein supplement. Each subject will utilize a 30g serving of whey isolate for 6 weeks of their study and for the other 6 weeks the subject will use a single serving (1tablespoon) of Genepro Gen2 Protein.
Subject were given the following eating guidelines:
- Eat slowly and chew small bites of food thoroughly.
- Avoid rice, bread, raw vegetables, fresh fruits, and meats that are not easily chewed such as pork and steak. Ground meats are usually better tolerated.
- With soft and solid foods, take only three bites at one sitting, then wait a minimum of 20 minutes before eating more.
- Eat balanced meals with small portions.
- Avoid the use of drinking straws and carbonated beverages, chewing gum and ice because they can introduce too much air into your pouch and cause discomfort.
- Avoid sugar, sugar-containing foods and beverages, concentrated sweets, and fruit juices Alcoholic beverages will have a more profound effect and should be avoided or consumed with caution.
Exercise: Each subject is asked to exercise for 30 to 45 minutes a day, with cardio or aerobic activity three to five times a week. Initially, we recommend walking five minutes in the morning and five minutes in the late afternoon. As tolerated you should increase these intervals by five minutes until you are walking at least 15 minutes twice per day.
- Being tested
- Genepro Protein, Whey Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genepro ProteinDietary supplement
Also called Genepro
weekly blood draws to measure blood protein levels
Whey ProteinDietary supplement
Also called Whey Protein Isolate
weekly blood draws to measure blood protein levels
| Study group | Role | What they receive |
|---|---|---|
| Genepro Gen2 Protein | Active comparator | 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. Receives: Dietary Supplement: Genepro Protein |
| Whey Protein Isolate | Active comparator | 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. Receives: Dietary Supplement: Whey Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Blood Draws to Measure Blood Protein Levels
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
Measured: 6 weeks per intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Analysis, Event HistoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musclegen Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Michael, RN, Principal investigator, Musclegen Research, Inc.Brian M Parks, PHD, Study director, MedFit Rx, Inc.Tony R Parks, BS, Principal investigator, MedFit Rx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919657
- Sponsor's protocol ID
- Genepro Gen 2
- Status last verified
- Mar 2017
- First submitted
- 19 Sep 2016
- Last updated
- 24 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 10 subjects will be administered genepro for the first 6 weeks of the study and whey protein the last 6 week. The other 10 subjects will be administered whey protein for the first 6 weeks of the study and Genepro Gen2 for the last 6 weeks. Weekly blood draws will be taken from each subject to analyze blood protein levels.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.
- ClinicalTrials.gov ID
- NCT02919657
- Acronym / sponsor ID
- Genepro Gen 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Musclegen Research, Inc.University, hospital or other
- Study start
- Jun 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 1 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genepro Gen2 Absorption and Protein Value Clinical Trial.
Detailed description
Objective: To prove the absorbability and usability of Genepro Gen2 Protein and compared to whey isolate. This study is intended to show the equivalent value of Genepro Gen2 as compared to whey protein isolate (1 tablespoon Genepro Gen2 compared to 30g serving of whey isolate)
Parameters: This study encompasses a 12-week program that follows 20 gastric bypass patients that have undergone weight loss surgery. We took a baseline blood analysis prior to the start of the study and subsequently we took weekly blood work to chart and register the findings. For this study we will only be doing the weekly analysis on blood protein levels by utilizing Spectrophotometry. The target blood protein range is 6.1-8.7 g/dL this test is administered while fasting.
Participants: 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.
Gathering Results: 10 subjects will receive Genepro Gen 2 protein (1 tablespoon serving) for the first 6 weeks of the study and for the last six weeks, they will receive 30g of Whey protein. In conjunction the other group of 10 subjects will receive 30g whey protein the first 6 weeks of the study and Genepro Gen2 protein the final six weeks. Weekly blood analysis will determine blood protein levels.
Diet: Diet guidelines limit the calories you consume while providing you with balanced meals to help prevent nutritional deficiencies and preserve your muscle tissue. Each patient tolerates suggested foods differently.
Daily calories should be between 600 to 700 for the duration of this study. Each subject is to follow a diet low in calories, fats and sweets. The goal for each subject is to consume a minimum of 65 to 75 grams of protein a day. High protein foods include eggs, meats, fish, seafood, tuna, poultry, tofu, milk, soy, cottage cheese, and yogurt. 30g of each daily intake of protein will be provided by a powdered protein supplement. Each subject will utilize a 30g serving of whey isolate for 6 weeks of their study and for the other 6 weeks the subject will use a single serving (1tablespoon) of Genepro Gen2 Protein.
Subject were given the following eating guidelines:
- Eat slowly and chew small bites of food thoroughly.
- Avoid rice, bread, raw vegetables, fresh fruits, and meats that are not easily chewed such as pork and steak. Ground meats are usually better tolerated.
- With soft and solid foods, take only three bites at one sitting, then wait a minimum of 20 minutes before eating more.
- Eat balanced meals with small portions.
- Avoid the use of drinking straws and carbonated beverages, chewing gum and ice because they can introduce too much air into your pouch and cause discomfort.
- Avoid sugar, sugar-containing foods and beverages, concentrated sweets, and fruit juices Alcoholic beverages will have a more profound effect and should be avoided or consumed with caution.
Exercise: Each subject is asked to exercise for 30 to 45 minutes a day, with cardio or aerobic activity three to five times a week. Initially, we recommend walking five minutes in the morning and five minutes in the late afternoon. As tolerated you should increase these intervals by five minutes until you are walking at least 15 minutes twice per day.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genepro Gen2 Protein | Active comparator | Dietary Supplement: Genepro Protein1 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. |
| Whey Protein Isolate | Active comparator | Dietary Supplement: Whey Protein30g Serving of Whey Isolate Protein will be used daily in each subject. Intervention: Weekly blood draws will determine the effect on blood protein levels. |
Who may qualify
- Ages
- 30 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Any digestive distress disorder (IBS, Crones, etc).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genepro ProteinAlso: Geneproweekly blood draws to measure blood protein levels | Dietary supplement | Genepro Gen2 Protein |
| Whey ProteinAlso: Whey Protein Isolateweekly blood draws to measure blood protein levels | Dietary supplement | Whey Protein Isolate |
Primary outcome
Weekly Blood Draws to Measure Blood Protein Levels
Time frame: 6 weeks per intervention
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 10 subjects will be administered genepro for the first 6 weeks of the study and whey protein the last 6 week. The other 10 subjects will be administered whey protein for the first 6 weeks of the study and Genepro Gen2 for the last 6 weeks. Weekly blood draws will be taken from each subject to analyze blood protein levels.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Michael, RN principal investigator
Musclegen Research, Inc.
Brian M Parks, PHD study director
MedFit Rx, Inc.
Tony R Parks, BS principal investigator
MedFit Rx, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Genepro Protein and Whey Protein in people with Analysis, Event History and Absorption; Disorder, Protein, run by Musclegen Research, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Blood Draws to Measure Blood Protein Levels (time frame: 6 weeks per intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.