Absorption Comparison on Equivalency Value of Genepro Gen2

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02919657
• Other study ID #: Genepro Gen 2
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2016
• Last updated: November 30, 2016
• Start date: June 2016
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Musclegen Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Genepro Gen2 Absorption and Protein Value Clinical Trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 46 Years

Eligibility

• 20 Post Op Gastric Bypass patients.

• 10 men,

• 10 women.

• Minimum age 30

• Maximum age 46

• 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.

Exclusion Criteria:

• Any digestive distress disorder (IBS, Crones, etc).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Absorption; Disorder, Protein
• Analysis, Event History

Intervention

Dietary Supplement:
• Genepro Protein
weekly blood draws to measure blood protein levels
• Whey Protein
weekly blood draws to measure blood protein levels

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Musclegen Research, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks per intervention	No