Analysis, Event History Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening
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