InflammationNCT04467372
Tart Cherry Supplementation & Gut Microbiome and Inflammation
A study testing Tart cherry juice concentrate and Freeze dried tart cherry powder in people with Inflammation and Glucose Regulation, run by Ohio University at 1 site in United States.
Trial summary
There has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. Many formulations of cherry supplements exist, however there has been no comparison between these different types. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Glucose Regulation, Sleep
- What is being tested?
- Tart cherry juice concentrate and Freeze dried tart cherry powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2019to 1 Jul 2021
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-55 years old
- participate in 150 minutes of exercise per week
- non-smoker
- have no known allergy to cherries or cherry juice
- are not taking food supplements (turmeric/curcumin, cherry products, greens, etc.). -You must have access to the internet and be willing to record your food intake, physical activity and sleep quality/duration during the study.
Who cannot join
- not 18-55 years old.
- have quit smoking less than one year ago.
- have been diagnosed with a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.
- are currently being treated for arthritis or an inflammatory condition, such as arthritis, gout, lupus or Sjogren's syndrome.
- are currently being treated for cardiovascular disease, high blood pressure, fibromyalgia, or irritable bowel syndrome.
- are pregnant.
Show all 13Show fewer
- regularly consume cherries or are allergic to cherries.
- currently use anti-inflammatory medications.
- have used corticosteroids in the last two months.
- are not willing to follow a low polyphenol diet.
- are not willing to have blood drawn on 4 occasions.
- are not willing to provide a stool sample on 3 occasions.
- do not have access to the internet.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio University Exercise Physiology Lab
Athens, Ohio, 45701
About this study
Official title: The Effects Supplementation of Tart Cherry or Placebo on the Gut Microbiome, Inflammation, Oxidative Stress, and Health-related Outcomes.
There has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. Many formulations of cherry supplements exist, however there has been no comparison between these different types. This is particularly important in the realm of inflammation research because sugar is known to increase the inflammatory response. The pill form of cherry supplementation has no added sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar. Recent work indicates tart cherry consumption can change gut microbiota, which may modify inflammation. The purpose of this study is to look at the effects of taking a cherry supplement, either in capsule or juice form, on the gut microbiome, inflammation, and health-related variables such as blood pressure, glucose regulation and sleep quality.
Read the detailed description
Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online survey for which the link will be emailed. Participants will maintain normal diet and exercise routine and to track these for the duration of the study.
- Conditions
- Inflammation, Glucose Regulation, Sleep
- Being tested
- Tart cherry juice concentrate, Juice placebo, Freeze dried tart cherry powder, Capsule placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart cherry juice concentrateDietary supplement
Two 8oz bottles of tart cherry juice concentrate daily for 30 days
Juice placeboDietary supplement
Two 8oz bottles of placebo juice daily for 30 days
Freeze dried tart cherry powderDietary supplement
Two freeze dried tart cherry powder capsules daily for 30 days
Capsule placeboDietary supplement
Two placebo capsules daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Tart cherry juice concentrate | Experimental | tart cherry juice Receives: Dietary Supplement: Tart cherry juice concentrate |
| Freeze dried tart cherry powder | Experimental | tart cherry capsules Receives: Dietary Supplement: Freeze dried tart cherry powder |
| Juice placebo | Experimental | kool-aid Receives: Dietary Supplement: Juice placebo |
| Capsule placebo | Experimental | maltodextrin Receives: Dietary Supplement: Capsule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via plasma glucose (mg/dL)
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via insulin (mIU/L)
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via glycated albumin (%).
Measured: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in sleep quantity (hours and minutes) assessed via daily survey.
Measured: daily for 30 days
Changes in sleep quality measured via 100mm visual analogue scale.
Measured: daily for 30 days
Changes in gut microbiome bacterial counts
Measured: baseline, 14 days, and 30 days post supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start18 Mar 2019
- Primary completion16 Oct 2019
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Hillman, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467372
- Sponsor's protocol ID
- 18-F-13
- Status last verified
- Sep 2021
- First submitted
- 30 Jun 2020
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available by request
Publications
Hillman AR, Chrismas BCR. Thirty Days of Montmorency Tart Cherry Supplementation Has No Effect on Gut Microbiome Composition, Inflammation, or Glycemic Control in Healthy Adults. Front Nutr. 2021 Sep 16;8:733057. doi: 10.3389/fnut.2021.733057. eCollection 2021.
PubMed 34604282
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Supplementation of Tart Cherry or Placebo on the Gut Microbiome, Inflammation, Oxidative Stress, and Health-related Outcomes.
- ClinicalTrials.gov ID
- NCT04467372
- Acronym / sponsor ID
- 18-F-13
- Conditions
- Inflammation, Glucose Regulation, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 13 Jul 2020 (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.
There has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. Many formulations of cherry supplements exist, however there has been no comparison between these different types. This is particularly important in the realm of inflammation research because sugar is known to increase the inflammatory response. The pill form of cherry supplementation has no added sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar. Recent work indicates tart cherry consumption can change gut microbiota, which may modify inflammation. The purpose of this study is to look at the effects of taking a cherry supplement, either in capsule or juice form, on the gut microbiome, inflammation, and health-related variables such as blood pressure, glucose regulation and sleep quality.
Detailed description
Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online survey for which the link will be emailed. Participants will maintain normal diet and exercise routine and to track these for the duration of the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tart cherry juice concentrate | Experimental | Dietary Supplement: Tart cherry juice concentratetart cherry juice |
| Freeze dried tart cherry powder | Experimental | Dietary Supplement: Freeze dried tart cherry powdertart cherry capsules |
| Juice placebo | Experimental | Dietary Supplement: Juice placebokool-aid |
| Capsule placebo | Experimental | Dietary Supplement: Capsule placebomaltodextrin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-55 years old
- participate in 150 minutes of exercise per week
- non-smoker
- have no known allergy to cherries or cherry juice
- are not taking food supplements (turmeric/curcumin, cherry products, greens, etc.). -You must have access to the internet and be willing to record your food intake, physical activity and sleep quality/duration during the study.
Key exclusion criteria (13 listed)
- not 18-55 years old.
- have quit smoking less than one year ago.
- have been diagnosed with a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.
- are currently being treated for arthritis or an inflammatory condition, such as arthritis, gout, lupus or Sjogren's syndrome.
- are currently being treated for cardiovascular disease, high blood pressure, fibromyalgia, or irritable bowel syndrome.
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 |
|---|---|---|
| Tart cherry juice concentrateTwo 8oz bottles of tart cherry juice concentrate daily for 30 days | Dietary supplement | Tart cherry juice concentrate |
| Juice placeboTwo 8oz bottles of placebo juice daily for 30 days | Dietary supplement | Juice placebo |
| Freeze dried tart cherry powderTwo freeze dried tart cherry powder capsules daily for 30 days | Dietary supplement | Freeze dried tart cherry powder |
| Capsule placeboTwo placebo capsules daily for 30 days | Dietary supplement | Capsule placebo |
Primary outcome
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via plasma glucose (mg/dL)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via insulin (mIU/L)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via glycated albumin (%).
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in sleep quantity (hours and minutes) assessed via daily survey.
Time frame: daily for 30 days
Changes in sleep quality measured via 100mm visual analogue scale.
Time frame: daily for 30 days
Changes in gut microbiome bacterial counts
Time frame: baseline, 14 days, and 30 days post supplementation.
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 9 Sep 2021.
- Derived from this study: PubMed 34604282Hillman AR, Chrismas BCR. Thirty Days of Montmorency Tart Cherry Supplementation Has No Effect on Gut Microbiome Composition, Inflammation, or Glycemic Control in Healthy Adults. Front Nutr. 2021 Sep 16;8:733057. doi: 10.3389/fnut.2021.733057. eCollection 2021.
- Individual participant dataSharing planned: No. Available by request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart cherry juice concentrate and Freeze dried tart cherry powder in people with Inflammation and Glucose Regulation, run by Ohio 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 5 inclusion and 13 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 9 Sep 2021. 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?
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL) (time frame: baseline, 7 days, 14 days, and 30 days post supplementation.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04467372, which also lists 1 linked publication.
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 9 Sep 2021.