Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04615858 |
| Other study ID # |
Genepro Gen3 |
| Secondary ID |
033300391Patent |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
February 1, 2021 |
Study information
| Verified date |
November 2020 |
| Source |
Musclegen Research, Inc. |
| Contact |
Brian M Parks, PHD |
| Phone |
9196109893 |
| Email |
bparks[@]geneproprotein.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
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
