The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2017
CompletedFirst Posted
Study publicly available on registry
July 17, 2017
CompletedStudy Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 25, 2018
June 1, 2018
9 months
June 27, 2017
June 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Inflammatory Bio Markers
A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.
Study Arms (2)
Regular Exercise Group
EXPERIMENTALat 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
ACTIVE COMPARATORat least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Loma Linda Health
Loma Linda, California, 92350, United States
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
JeJe Noval, PhD
Loma Linda University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 27, 2017
First Posted
July 17, 2017
Study Start
August 21, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
June 25, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share