The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Ginger

• Registration Number: NCT03219463
• Lead Sponsor: Loma Linda University

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2017-08-21
• Status Verified: 2018-06
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regular Exercise Group	Ginger	at least 30 minutes of moderate to vigorous activity at least 3 times per week. Will recieve 3 grams of ginger for 8 weeks.
Non Regular Exercise Group	Ginger	at least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks.

Primary Outcome Measures

Name	Time	Method
SF-36 Questionnaire	Change from baseline to end of 8 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Bio Markers	A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.	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.

Trial Locations

Locations (1)

Loma Linda Health; 🇺🇸 Loma Linda, California, United States