The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Study Overview
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Brief Summary
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The purpose of our graduate student research study is to observe the effects of ginger on hsCRP, IL-6, and TNF-α levels in exercising individuals based on their level of activity.

Detailed Description
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Participants will fill out a demographic questionnaire and a quality of life survey, (SF-36). Take a 3g supplement of ginger in powder form with meals once/day (preferably in the morning) for 8 weeks. By end of week 4 (halfway through the study), subjects will do another blood test for mid-intervention CRP, IL-6, and TNF-α values. By end of week 8, participants will do a final blood test for CRP values and fill out the SF-36 survey for post-intervention levels.

Official Title
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The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Ginger


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30 - 70 years of age Various levels of activity outlined by the General Physical Activities Defined by Level of Intensity by the American College of Sports Medicine (ACSM) and the Centers for Disease Control and Prevention (CDC). Regular Exercisers- at least 30 minutes of moderate to vigorous activity at least 3 times per week. Non-regular Exercisers- at least 30 minutes of moderate to vigorous activity 1-2 times per week. Exclusion Criteria: Individuals currently taking... Vit D Aspirin Coumadin Ginger supplements more than 1x/week within the last month Heparin NSAIDs Pain meds Individuals with chronic inflammatory conditions such as Cancer, CVD, Diabetes, Gastroesophageal reflux disease (GERD), Ginger allergies, Metabolic Syndrome, and/or autoimmune diseases such as Rheumatoid Arthritis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular Exercise Group<br>at least 30 minutes of moderate to vigorous activity at least 3 times per week. Will recieve 3 grams of ginger for 8 weeks. | Dietary Supplement: Ginger<br>* 3g ginger powder supplement once a day with meals (preferably in the morning) for a duration of 8 weeks. Powder can be mixed with juice or water.<br>|
| Active Comparator: Non Regular Exercise Group<br>at least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks. | Dietary Supplement: Ginger<br>* 3g ginger powder supplement once a day with meals (preferably in the morning) for a duration of 8 weeks. Powder can be mixed with juice or water.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36 Questionnaire | Quality of life will be assessed using the 36-item Short Form Survey Instrument (SF-36). It was developed by the RAND corporation. The SF-36 is a well accepted and valid survey used to assess overall health measuring 8 different dimensions including physical and social functionality and limitations, mental health, vitality, pain, general health perception, and health change.20 It is a self-administered survey that takes about 10 minutes to complete. | Change from baseline to end of 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Bio Markers | Inflammation will be measured using the biomarkers Interleukin-6 (IL-6), Tumor Necrosis Factor Alpha (TNF-α), and C-reactive Protein (CRP) using a venipuncture blood draw. Venous blood will be drawn from the antecubital vein using a standard venipuncture protocol for a total of 8 mL or 0.5 tablespoons of blood. | A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks. |