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临床试验/NCT02919657
NCT02919657已完成4 期

Genepro Gen2 Equivalency Study as Compared to Whey Isolate (1 Tablespoon of Genepro Gen2 and 30g Whey Isolate.

Musclegen Research, Inc.0 个研究点目标入组 20 人开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
主要终点
Weekly Blood Draws to Measure Blood Protein Levels

研究概览

简要总结

Genepro Gen2 Absorption and Protein Value Clinical Trial.

详细描述

Objective: To prove the absorbability and usability of Genepro Gen2 Protein and compared to whey isolate. This study is intended to show the equivalent value of Genepro Gen2 as compared to whey protein isolate (1 tablespoon Genepro Gen2 compared to 30g serving of whey isolate)

Parameters: This study encompasses a 12-week program that follows 20 gastric bypass patients that have undergone weight loss surgery. We took a baseline blood analysis prior to the start of the study and subsequently we took weekly blood work to chart and register the findings. For this study we will only be doing the weekly analysis on blood protein levels by utilizing Spectrophotometry. The target blood protein range is 6.1-8.7 g/dL this test is administered while fasting.

Participants: 20 Post Op Gastric Bypass patients. 10 men, 10 women. All participants were between the ages of 30-46 years of age. All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.

Gathering Results: 10 subjects will receive Genepro Gen 2 protein (1 tablespoon serving) for the first 6 weeks of the study and for the last six weeks, they will receive 30g of Whey protein. In conjunction the other group of 10 subjects will receive 30g whey protein the first 6 weeks of the study and Genepro Gen2 protein the final six weeks. Weekly blood analysis will determine blood protein levels.

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
30 Years 至 46 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 20 Post Op Gastric Bypass patients.
  • 10 women.
  • Minimum age 30
  • Maximum age 46
  • All participants have been post operation from their weight loss surgery for a minimum of 3 months prior to the start of the study and no longer than 12 months at the start of the study.

排除标准

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

结局指标

主要结局

Weekly Blood Draws to Measure Blood Protein Levels

时间窗: 6 weeks per intervention

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

次要结局

未报告次要终点

研究者

发起方
Musclegen Research, Inc.
申办方类型
Other
责任方
Sponsor

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