Protein Intervention Methods

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Protein Study Intervention: Methods and Investigation Process Steps

The following are the study process steps including study enrollment procedures, study methods and evaluation plan.

Study Enrollment Procedures for participants and staff:
1. Selection of Staff Members and Recruitment: Staff Members will be recruited from a local Hospital System. A Geriatricians and Therapist will be recruited for the baseline and

follow-up measurements. The therapist must be familiar with geriatric patients. A
Statistician will be recruited Montclair State University. The timeframe for this task is first quarter, 2017.

2. Train Staff Members: Staff members will include Montclair State University undergraduate and graduate studies who will be paid per hour
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The study participants will be divided into 3 intervention groups. The 100 study participants will be randomly divided between 3 protein supplementation groups. Groups 1,2,3 will be supplemented respectively with additional .2g/kg, .4g/kg, or .6g/kg per meal of protein of their choice. Shop Rite Supermarkets committed to providing study protein supplementation food (letter is available).

7. Food Frequency Questionnaires along with Lifestyle questionnaires will be mailed to study participants. Questions from participants on questionnaires will be fielded by Montclair State Graduate students who will be trained on intent of questions. Study participants will be instructed to bring completed questionnaire. The timeframe for this task is June 2017 with a return request of July 15, 2017. The specific FFQ which will be administered was created for the European Prospective Investigation into Cancer and Nutrition Study.

8. Montclair State Graduate students will schedule participants for baseline and follow-up measurements and assist in recording all study data. All study measurements will be conducted on-site in a designated classroom at the university and set-up of room will be coordinated by project director and graduate students. This task is planned for an August 1 through August 21, 2017
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Montclair State graduate students along with project director will coordinate 3 month follow-up for all study participants which will occur December 10 through December 21, 2017 at Montclair State University campus. Phlebotomists will draw blood from all study participants at follow-up and coordinate transport of specimens to laboratory. Geriatrician will evaluate overall health of participant at follow-up. Therapist will measure knee strength. Exit interview will be conducted with each participant including questions on the number of falls which occurred for the participant during the study.

18. Project Director will ensure all data from baseline and follow-up including all study related information is entered into SPSS software. Project Director will coordinate study data evaluation by statistician. This task is planned for first quarter 2018.

19. Statistician will compile all study related data to determine study results during the first quarter of 2018.

20. Project Director will deliver study results to all interested parties and conduct study close- out and reporting activities. Reporting will include determination of changes in muscle strength in all study participants based upon study intervention. Blood biomarkers measuring inflammatory responses will be correlated against changes in study participant’s muscle

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