Genepro Generation 3 Protein Bioavailability Compared to Whey Protein (Gen3)

November 9, 2020 updated by: Musclegen Research, Inc.

Genepro Generation 3 Bioavailability Compared to Whey Protein (12g Genepro vs 30g Whey)

Objective of Clinical Trial: To test, in a blinded study the bioavailability of Genepro Generation 3 (GEN3) Protein as compared to whey protein. This study is intended to show the equivalent value of Genepro Gen3 as compared to whey protein (1scoop (12g) Genepro Generation 3 (GEN3) compared to 30g serving of whey protein). Total Serum Protein levels will be tested every other week to evaluate blood protein levels in each participant

Study Overview

Detailed Description

Detailed Description:

Condition or Disease: Analysis, Event History. Absorption; Disorder, protein

Objective of Clinical Trial: To test, in a blinded study the bioavailability of Genepro Generation 3 (GEN3) Protein as compared to whey protein. This study is intended to show the equivalent value of Genepro Gen3 as compared to whey protein (1scoop (12g) Genepro Generation 3 (GEN3) compared to 30g serving of whey protein). Total Serum Protein levels will be tested every other week to evaluate blood protein levels in each participant.

Parameters: This study encompasses a 6-week program that follows 40 gastric bypass patients that have undergone weight loss surgery. We will establish a baseline blood analysis prior to the start of the study and subsequently we will take bi-weekly blood work to chart and register the findings (weeks 2, 4 and 6). For this study we will only be doing the bi-weekly analysis on blood protein levels by utilizing Spectrophotometry with total serum protein. The target blood protein range is 6.1-8.7 g/dL this test is administered without fasting.

Participants: 40 Post Op Gastric Bypass patients. 20 men, 20 women. All participants were between the ages of 25-80 years of age. All participants have been post operation from their weight loss surgery for a minimum of 6 months prior to the start of the study and no longer than 8 months at the start of the study. Participants will be randomly selected, blindly, by the study sponsor. The selection will utilize participants files with names and ethnicity removed. Selection will be randomized into Group A and Group B. One group will be assigned Genepro while the other group will be assigned a leading whey protein powder. Participants will be assigned a Identification Code/Number for the duration of the study. Results will be posted using this identification number as well as stating the age and gender of the participant. Participant names will be held in confidence. Participants must maintain a daily log that will be shared with study investigators. This log will contain daily lists of food and beverage consumed as well as personal thoughts on taste and ease of use of protein supplements as well as a daily synopsis of overall general emotional and physical feelings.

Participant Compensation: Three (3) thirty serving units of Genepro Generation 3 at the conclusion of the study.

Gathering Results: 40 subjects will receive Genepro Generation 3 protein (12g serving) for one week prior to the study as well as all 6 weeks of the study. In conjunction the other group of 20 subjects will receive 30g whey protein for one week prior to the study as well as all 6 weeks of the study. Bi-Weekly blood analysis will determine blood protein levels. Blood draws are to be conducted at a WakeMed facility (Cary, NC or Raleigh, NC - determined by the proximity to the patient for their convenience). Results will be submitted for review and entry from WakeMed to the sponsor oversight POC every 2 weeks. To ensure proper transfer of data, WakeMed will keep and store all lab reports/results for a minimum of 2 years after the conclusion of the study. Soft copies will be inserted into a virtual storage center to be maintained and accessible by both, the sponsor as well as the medical partners.

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. 20 subjects will utilize a 30g serving of whey protein for 1 week prior to the study as well as 6 weeks of the study. The other group of 20 subjects will use a single serving (12g) of Genepro Gen3 Protein over the same duration.

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.

Storage and Distribution of Protein Powder: WakeMed Clinical Oversight Manager and Principal Investigator, Marina Maddaloni, will be provided with a lockable storage container to be positioned in her personal office. WakeMed will be provided white and black containers. One color will house either Genepro or regular Whey protein. WakeMed will not have knowledge of which color container holds which protein powder to ensure that the distribution to participants is totally blinded. Participants will be given enough protein supplementation, either regular whey or Genepro Generation 3 protein, to last the duration of the study.

Peer Reviewer 1: Dr. Brian M. Parks Peer Reviewer 2: Zac Cain Non-Peer Review: Dr. Jon Bruce

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Recruiting
        • WakeMed Bariatric Surgery Center
        • Contact:
          • Lamonica Daniel
        • Contact:
          • Marina Maddaloni
        • Sub-Investigator:
          • Marina Maddaloni
        • Principal Investigator:
          • John Bruce, MD
        • Principal Investigator:
          • LaMonica Daniel
      • Raleigh, North Carolina, United States, 27610
        • Not yet recruiting
        • WakeMed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

INCLUSION CRITERIA:

  • Participants will be solicited to volunteer through WakeMed Bariatric Surgery Center (current patients)
  • All participants must have normal blood protein levels prior to the study
  • All participants must be six months post op (bariatric surgery)
  • All participants must avoid any other protein supplementation during the trial period
  • All participants are required to maintain a daily nutrition log
  • All participants must have no milk/dairy allergies
  • Age Eligibility: 25 years to 80 years (Adult)
  • Sexes Eligibility for Study: ALL
  • Only Accepts Healthy Volunteers

EXCLUSION CRITERIA:

  • No candidates with prior digestive distress disorders (IBS, Crones, etc.)
  • Participants with any negative GI score, they will be excluded from the study
  • Participants with abnormal blood protein levels at the time of study
  • Unhealthy Volunteers
  • Volunteers with compromised immune systems
  • Volunteers younger than 25 years of age
  • Volunteers older than 80 years of age
  • Allergies to milk or lactose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Genepro Generation 3
1 scoop, 11g, Genepro Generation 3 Protein daily will be used by Group A (20 participants) 10 male, 10 female participants 6 months post bariatric surgery.
Generation 3 Genepro Protein. Micronized protein. Zero lactose. No gluten. All Natural. No flavor. No Sugar. FODMAP Certified protein. 11g in weight, scoop.
ACTIVE_COMPARATOR: Whey Protein
1 scoop, 30g, Whey Protein daily will be used by Group B (20 participants) 10 male, 10 female participants 6 months post bariatric surgery.
Nutrition industries number 1 selling whey protein powder. No flavor. Gluten Free. 30g scoop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Protein Levels
Time Frame: 6 weeks
Each participant in each group will have blood protein levels checked via blood draw at a WakeMed facility (based on participants geographic location). The target blood protein range is 6.1-8.7 g/dL this test is administered without fasting.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Marina Maddaloni, WakeMed Bariatric Surgery Center
  • Study Chair: Zac Cain, Genepro Protein, Inc.
  • Study Director: Brian Parks, PHD, Genepro Protein, Inc.
  • Principal Investigator: John Bruce, MD, WakeMed Bariatric Surgery Center
  • Study Chair: LaMonica Daniel, WakeMed Health & Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2020

Primary Completion (ANTICIPATED)

January 26, 2021

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (ACTUAL)

November 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Genepro Gen3
  • 033300391 (OTHER: US DOD)
  • Patent Pending (OTHER: USPTO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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