search
Back to results

The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ginger
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Loma Linda Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Regular Exercise Group

Non Regular Exercise Group

Arm Description

at least 30 minutes of moderate to vigorous activity at least 3 times per week. Will recieve 3 grams of ginger for 8 weeks.

at least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 27, 2017
Last Updated
June 20, 2018
Sponsor
Loma Linda University
search

1. Study Identification

Unique Protocol Identification Number
NCT03219463
Brief Title
The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
Official Title
The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 21, 2017 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Exercise Group
Arm Type
Experimental
Arm Description
at least 30 minutes of moderate to vigorous activity at least 3 times per week. Will recieve 3 grams of ginger for 8 weeks.
Arm Title
Non Regular Exercise Group
Arm Type
Active Comparator
Arm Description
at least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger
Intervention Description
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.
Primary Outcome Measure Information:
Title
SF-36 Questionnaire
Description
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.
Time Frame
Change from baseline to end of 8 weeks.
Secondary Outcome Measure Information:
Title
Inflammatory Bio Markers
Description
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.
Time Frame
A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JeJe Noval, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effects of Ginger Supplementation on Inflammation in Exercising Individuals

We'll reach out to this number within 24 hrs