The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Healthy Clinical Trial

Official title:

The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03219463
• Other study ID #: 5170187
• Status: Completed
• Phase: N/A
• Start date: August 21, 2017
• Est. completion date: June 1, 2018

Study information

• Verified date: June 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2018
• Est. primary completion date: June 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Inflammation

Intervention

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.

Locations

Country	Name	City	State
United States	Loma Linda Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inflammatory Bio Markers	Inflammation will be measured using the biomarkers Interleukin-6 (IL-6), Tumor Necrosis Factor Alpha (TNF-a), 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.