Genepro Protein
Dietary Supplementweekly blood draws to measure blood protein levels
Other names: Genepro
NCT Number: NCT02919657
Genepro Gen2 Absorption and Protein Value Clinical Trial.
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Notify Me30 year–46 year
All sexes
Interventional
Phase 4
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Exclusion criteria
weekly blood draws to measure blood protein levels
Other names: Genepro
weekly blood draws to measure blood protein levels
Other names: Whey Protein Isolate
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
Musclegen Research, Inc.
Other
Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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