Clinical trial NCT04615858: Genepro Generation 3 Protein Bioavailability Compared to Whey Protein
Official title: Genepro Generation 3 Bioavailability Compared to Whey Protein (12g Genepro vs 30g Whey)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Absorption; Disorder, Protein
Protein Malabsorption
Protein Intolerance
Keywords: protein
absorption
Lead sponsor: Musclegen Research, Inc.
Sponsor class: OTHER
Collaborators: name: WakeMed Bariatric Surgery & Weight Loss Center
First posted: 2020-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Blood Protein Levels
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cary
country: United States
facility: WakeMed Bariatric Surgery Center
state: North Carolina
city: Raleigh
country: United States
facility: WakeMed
state: North Carolina
Study officials:
affiliation: WakeMed Bariatric Surgery Center
name: Marina Maddaloni
role: STUDY_CHAIR
affiliation: Genepro Protein, Inc.
name: Zac Cain
role: STUDY_CHAIR
affiliation: Genepro Protein, Inc.
name: Brian Parks, PHD
role: STUDY_DIRECTOR
affiliation: WakeMed Bariatric Surgery Center
name: John Bruce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: WakeMed Health & Hospitals
name: LaMonica Daniel
role: STUDY_CHAIR
References: