Recruiting

Genepro vs. Whey

Sponsor:

Musclegen Research, Inc.

Code:

NCT04615858

Conditions

Absorption; Disorder, Protein

Protein Malabsorption

Protein Intolerance

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

Interventions

Genepro Generation 3 Protein

Whey Protein

Study Details

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

Study ID

NCT04615858

Start date

Dec 1, 2020

Status verified date

Nov, 2020

Completion date

Feb 1, 2021

Anticipated

Primary completion date

Jan 26, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Genepro Generation 3 Protein

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

Whey Protein

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

Primary outcome measure

  • Blood Protein Levels [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Brian M Parks, PHD

9196109893bparks@geneproprotein.net

Zac Cain

9194551374zcain@musclegenresearch.com

Locations

WakeMed Bariatric Surgery Center

Recruiting

Cary, North Carolina, United States, 27511

Principal Investigator:

John Bruce, MD

More Information

Sponsor

Musclegen Research, Inc.

Last update posted

Nov 10, 2020

Last verified

Nov, 2020

Keywords

  • protein
  • absorption

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Musclegen Research, Inc. on 2020-11-10.