The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Ginger

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular Exercise Group; 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; 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.
Active Comparator: Non Regular Exercise Group; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: JeJe Noval, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (Actual): July 17, 2017

Study Record Updates

• Last Update Posted (Actual): June 25, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 5170187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No