Absorption Comparison on Equivalency Value of Genepro Gen2
Condition: Analysis, Event History; Absorption; Disorder, Protein
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Intervention name(s): Genepro Protein; Whey Protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): weekly blood draws to measure blood protein levels; weekly blood draws to measure blood protein levels
Other intervention name(s): Genepro; Whey Protein Isolate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening