Absorption Comparison on Equivalency Value of Genepro Gen2

NCT02919657 | Completed Phase 4 Results DMC

• 1 other identifier: Genepro Gen 2
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Genepro Gen2 Absorption and Protein Value Clinical Trial.

Conditions

Analysis, Event History; Absorption; Disorder, Protein

Outcome Measures

Primary Outcomes (1)

• Weekly Blood Draws to Measure Blood Protein Levels

  Each week the 20 participants will have blood drawn to measure their blood protein levels. Each participant was required to give blood weekly to determine the blood protein levels. The results show the average over each six week period of testing for each row. Each participant was examined to see if they achieved the average range as set fourth by the dieticians of greater than 6.1 and less than 8.7 within a 10% variable as acceptable. 10 Participants will be given Genepro Gen2 for the first six weeks of the study and whey protein for the final 6. 10 Participants will be given when protein for the first six weeks of the study and Genepro Gen2 for the final 6. These measurements will read in g/dl

  6 weeks per intervention

Study Arms (2)

Genepro Gen2 Protein

ACTIVE COMPARATOR

1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject. Intervention: Weekly blood draws will determine the effect on blood protein levels.

Dietary Supplement: Genepro Protein

Whey Protein Isolate

ACTIVE COMPARATOR

30g Serving of Whey Isolate Protein will be used daily in each subject. Intervention: Weekly blood draws will determine the effect on blood protein levels.

Dietary Supplement: Whey Protein

Interventions

Genepro Protein DIETARY_SUPPLEMENT

weekly blood draws to measure blood protein levels

Also known as: Genepro

Genepro Gen2 Protein

Whey Protein DIETARY_SUPPLEMENT

weekly blood draws to measure blood protein levels

Also known as: Whey Protein Isolate

Whey Protein Isolate

Eligibility Criteria

• Age: 30 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Any digestive distress disorder (IBS, Crones, etc).

Sponsors & Collaborators

• Musclegen Research, Inc.: lead

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

Results Point of Contact

• Title: David Michael
• Organization: Medfit Rx

dmichael@medfitrx.net

9196109893

Study Officials

• David Michael, RN

  Musclegen Research, Inc.

  PRINCIPAL INVESTIGATOR

• Brian M Parks, PHD

  MedFit Rx, Inc.

  STUDY DIRECTOR

• Tony R Parks, BS

  MedFit Rx, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 29, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 24, 2017
• Results First Posted: December 1, 2016

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share