Genepro Gen2 Absorption and Protein Value Clinical Trial.

Absorption Comparison on Equivalency Value of Genepro Gen2

Analysis, Event History

Absorption; Disorder, Protein

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.

Genepro Protein

Whey Protein

Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.

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

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.

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.

Absorption Comparison on Equivalency Value of Genepro Gen2

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?