Genepro Generation 3 Protein Bioavailability Compared to Whey Protein

NCT04615858 | Unknown DMC

• 3 other identifiers: Genepro Gen3033300391Patent Pending
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Conditions

Absorption; Disorder, Protein; Protein Malabsorption; Protein Intolerance

Keywords

protein; absorption

Outcome Measures

Primary Outcomes (1)

• Blood Protein Levels

  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

Study Arms (2)

Genepro Generation 3

ACTIVE COMPARATOR

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.

Dietary Supplement: Genepro Generation 3 Protein

Whey Protein

ACTIVE COMPARATOR

1 scoop, 30g, Whey Protein daily will be used by Group B (20 participants) 10 male, 10 female participants 6 months post bariatric surgery.

Dietary Supplement: Whey Protein

Interventions

Genepro Generation 3 Protein DIETARY_SUPPLEMENT

Generation 3 Genepro Protein. Micronized protein. Zero lactose. No gluten. All Natural. No flavor. No Sugar. FODMAP Certified protein. 11g in weight, scoop.

Genepro Generation 3

Whey Protein DIETARY_SUPPLEMENT

Nutrition industries number 1 selling whey protein powder. No flavor. Gluten Free. 30g scoop.

Whey Protein

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Musclegen Research, Inc.: lead
• WakeMed Bariatric Surgery & Weight Loss Center: collaborator

Study Sites (2)

WakeMed Bariatric Surgery Center

Cary, North Carolina, 27511, United States

RECRUITING

WakeMed

Raleigh, North Carolina, 27610, United States

NOT YET RECRUITING

MeSH Terms

Interventions

Whey Proteins

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Marina Maddaloni

  WakeMed Bariatric Surgery Center

  STUDY CHAIR

• Zac Cain

  Genepro Protein, Inc.

  STUDY CHAIR

• Brian Parks, PHD

  Genepro Protein, Inc.

  STUDY DIRECTOR

• John Bruce, MD

  WakeMed Bariatric Surgery Center

  PRINCIPAL INVESTIGATOR

• LaMonica Daniel

  WakeMed Health & Hospitals

  STUDY CHAIR

Central Study Contacts

Brian M Parks, PHD

CONTACT

9196109893; bparks@geneproprotein.net

Zac Cain

CONTACT

9194551374; zcain@musclegenresearch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Active Comparator: Genepro Gen2 Protein 11g Serving of Genepro Gen3 Protein daily will be used in each subject. Intervention: Bi-Weekly blood draws will determine the effect on blood protein levels. Active Comparator: Whey Protein Isolate 30g Serving of Whey Protein will be used daily in each subject. Intervention:Bi-Weekly blood draws will determine the effect on blood protein levels.
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 4, 2020
• Study Start: December 1, 2020
• Primary Completion: January 26, 2021
• Study Completion: February 1, 2021
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)