HealthyNCT03219463
The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
A study testing Ginger in people with Healthy, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ginger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Individuals currently taking...
- Vit D
- Aspirin
- Coumadin
- Ginger supplements more than 1x/week within the last month
- Heparin
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Ginger
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Regular Exercise Group | Experimental | at least 30 minutes of moderate to vigorous activity at least 3 times per week. Will recieve 3 grams of ginger for 8 weeks. Receives: Dietary Supplement: Ginger |
| Non Regular Exercise Group | Active comparator | at least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks. Receives: Dietary Supplement: Ginger |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to end of 8 weeks.
Secondary outcomes (1)
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.
Measured: A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start21 Aug 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JeJe Noval, Loma Linda University
- Investigators
- JeJe Noval, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219463
- Sponsor's protocol ID
- 5170187
- Status last verified
- Jun 2018
- First submitted
- 27 Jun 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ginger Supplementation on Inflammation in Exercising Individuals
- ClinicalTrials.gov ID
- NCT03219463
- Acronym / sponsor ID
- 5170187
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular Exercise Group | Experimental | Dietary Supplement: Gingerat 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 comparator | Dietary Supplement: Gingerat least 30 minutes of moderate to vigorous activity 1-2 times per week. Will recieve 3 grams of ginger for 8 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- Individuals currently taking...
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger3g 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. | Dietary supplement | Non Regular Exercise Group, Regular Exercise Group |
Primary outcome
SF-36 Questionnaire
Time frame: 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.
1 secondary outcome
Inflammatory Bio Markers
Time frame: A composite measurement from :1) at baseline 2) mid point (at 4weeks) and at 3) end of 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JeJe Noval, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger in people with Healthy, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Questionnaire (time frame: Change from baseline to end of 8 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.