ObesityPhase 1NCT05586386
Cherries Role in Gut Microbiota-liver-brain Function
A Phase 1 study testing Cherry group in people with Obesity, run by Texas A&M University at 1 site in United States.
Trial summary
Sweet cherries (Prunus avium) are a good source of bioactive compounds including dietary fiber and phytochemicals which have been credited with multiple health benefits, including anti-inflammatory and antioxidant properties as well as preventing obesity-related metabolic disorders. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Cherry group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 20 Sep 2021
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years old;
- No history of chronic diseases or intestinal disorders.
- BMI: ≥ 30 and ≤ 40.
Who cannot join
- History of acute cardiac event, stroke, or cancer
- Alcohol or substance abuse within the last 6 months
- Recurrent admittance to the hospital (twice or more)
- Allergy, intolerance, or sensitivity to berries
- Hepatitis (B or C) or HIV
- Smoking more than 1 pack/week
Show all 13Show fewer
- Liver or renal dysfunction
- Diabetic retinopathy
- History of glaucoma, retinitis pigmentosa, optic neuropathy, retinal vascular occlusions, strabismus, macular degeneration or autoimmune disorders related to visual health
- History of dizziness/fainting during and after blood draws
- Known lactose intolerance, gluten sensitivity, or celiac disease
- Currently on medications/antibiotics
- Pregnancy or lactation (or planned pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dark Sweet Cherry (DSC) Supplementation on the Gut Microbiota-liver-brain Axis in Obese Adults
Sweet cherries (Prunus avium) are a good source of bioactive compounds including dietary fiber and phytochemicals which have been credited with multiple health benefits, including anti-inflammatory and antioxidant properties as well as preventing obesity-related metabolic disorders. However, most studies have shown such benefits using in vitro or animal models. The aim of this study was to examine the influence of DSC consumption on obesity-associated inflammation, metabolic disorders, cognitive impairment, and gut dysbiosis in obese individuals.
Read the detailed description
The duration of an individual's participation in the study was 45 days (15 days for the run-in period plus 30 days of intervention):
- Screening: Eligible participants were contacted through e-mail and invited to participate in a familiarization session in which detailed information about the study along with the consent statement form was presented. Participants who met the eligibility criteria and signed the consent were scheduled for screening visits. During the screening visits, the anthropometric (waist circumference, height, weight, and BMI) and wellness measurements (blood pressure, heart rate, and oxygen saturation) were measured.
- Run-in period: Participants were asked to complete a 2-week run-in period in which dietary supplements were removed from the diet while maintaining usual dietary patterns. During the run-in period, participants were asked to complete 24-hour dietary records for 5 days to have the baseline information related to their dietary patterns. In addition, participants were asked to reduce their intake of polyphenol and fiber-rich foods. After the completion of the 2-week run-in period, participants were allocated into cherry or placebo groups according to BMI, age, and gender and scheduled for study visits 1, 15, and 30.
- Intervention: During the 30-day cherry or placebo supplementation, participants were asked to maintain usual physical activity and diet, and to minimize the intake of foods high in polyphenol content. Nutritional habits were evaluated using 15-day dietary records collected on Myfitnesspal. Participants were instructed to drink a cherry juice or corresponding placebo twice a day for 30 days. At each study visit (study days 1, 15, and 30), wellness checks (blood pressure, heart rate, and oxygen saturation) and anthropometric measurements (body weight, height, % of body fat, body mass index (BMI), waist and hip circumference) were recorded. Biomarkers of inflammation, metabolic disorders, and liver health were assessed on blood samples collected on study days 1 and 30. Participants were instructed to fast for 12 h. before each study appointment and to drink plenty of water to facilitate blood draws. Blood fractions were aliquoted and stored at -80 C until analyses. The gut microbiota composition was assessed on stool samples collected on study days 1 and 30. Participants were given stool collection kits and instructed to avoid the use of laxatives, stool softeners, and antiacids within 48 hr. before stool collection. Participants were asked to bring their samples on study days 1 and 30 within 2 h. of collection or to freeze them if collected a day prior until transport to our facility. Stool samples received by the research personnel were immediately stored at -80 ⁰C until analysis. Intestinal permeability, which is a feature of intestinal barrier function, was evaluated through the lactulose/mannitol/sucralose test in urine samples collected on study days 1 and 30. This test was optional for participants. On study days 1 and 30, participants were given urine collection kits and instructed to collect their samples within 5 h of drinking a sugary solution containing lactulose, mannitol, and sucralose. Samples were stored at -20°C until analysis. Cognitive function was monitored on study days 1 and 30 through interviewer-administered tests that provided information on executive function skills (visual search, scanning, working memory, processing speed, and attention). In addition, visual cognitive performance was monitored during the last 15 days of the intervention using the Visual Cognitive Testing and Training: NeuroTracker™ CORE program (NT) from CogniSens Inc, which is a single-task integrative perceptual-cognitive training system.
- Conditions
- Obesity
- Being tested
- Cherry group, Placebo group
- Keywords
- dark sweet cherry, anthocyanins, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry groupOther
200 mL of DSC juice twice/day supplemented with 3g of DSC powder twice/day for 30 days
Placebo groupOther
200 mL of placebo juice twice/day
| Study group | Role | What they receive |
|---|---|---|
| Cherry group | Experimental | Obese adults were asked to consume 200 mL of DSC juice supplemented with 3g of DSC powder twice / day for 30 days. Receives: Other: Cherry group |
| Placebo group | Experimental | Obese adults were asked to consume 200 mL of placebo juice supplemented twice / day for 30 days. Receives: Other: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline intestinal microbiota composition at 30 days
16S rRNA sequencing was used to evaluate the intestinal microbiota composition in stool samples collected on day 1 (baseline) and 30.
Measured: At day 1 (baseline) and day 30
Change from baseline liver health biomarkers at 30 days
Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase) levels were measured on fasting blood samples collected on day 1 and 30.
Measured: At day 1 (baseline) and day 30
Change from cognitive function at 30 days
The trail making tests (A and B) were administered on day 1 and 30 to evaluate executive attention, and visual-spatial functions (visual search and scanning, sequencing).
Measured: At day 1 (baseline) and day 30
Change from cognitive function at 30 days
The Digit Span tests (Forward and Backward) were administered on day 1 and 30 to evaluate working memory and concentration skills.
Measured: At day 1 (baseline) and day 30
Change from cognitive function at 30 days
The Digit Span Substitution test was administered on days 1 and 30 to evaluate processing speed, sustained attention, and visual perception.
Measured: At day 1 (baseline) and day 30
Secondary outcomes (3)
Change from baseline inflammatory biomarkers at 30 days
Biomarkers of inflammation such as pro-inflammatory cytokines (interleukins IL-6, -1β, -8, interferon gamma (INFγ), and monocyte chemoattractant (MCP-1)), and C-reactive protein (CRP) were assessed on fasting blood samples collected on day 1 (baseline) and day 30.
Measured: At day 1 (baseline) and day 30.
Visual cognitive performance
The visual cognitive testing and training: NeuroTracker (NT)™ CORE program was used to evaluate attention (sustained, selective, divided, inhibition), memory (short-term and working) and information processing speed. Participants completed ten sessions between days 15 and 30.
Measured: From day 15 to day 30.
Change from baseline lipid profile biomarkers at 30 days
Cholesterol (HDL, LDL, non-HDL) and triglyceride levels were measured on fasting blood samples collected on day 1 (baseline) and day 30.
Measured: At day 1 (baseline) and day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start6 Feb 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Obese adults (BMI: 30-40): 200 mL (\~6.7 oz.) of dark sweet cherry (DSC) juice supplemented with 3g of DSC powder twice per day for 30 days. Group 2: Obese adults (BMI: 30-40): 200 mL (\~6.7 oz.) of placebo juice twice per day for 30 days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuliana Noratto, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586386
- Sponsor's protocol ID
- IRB2019-0597F
- Status last verified
- Oct 2022
- First submitted
- 4 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dark Sweet Cherry (DSC) Supplementation on the Gut Microbiota-liver-brain Axis in Obese Adults
- ClinicalTrials.gov ID
- NCT05586386
- Acronym / sponsor ID
- IRB2019-0597F
- Conditions
- Obesity
- Keywords
- dark sweet cherry, anthocyanins, obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 19 Oct 2022 (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.
Sweet cherries (Prunus avium) are a good source of bioactive compounds including dietary fiber and phytochemicals which have been credited with multiple health benefits, including anti-inflammatory and antioxidant properties as well as preventing obesity-related metabolic disorders. However, most studies have shown such benefits using in vitro or animal models. The aim of this study was to examine the influence of DSC consumption on obesity-associated inflammation, metabolic disorders, cognitive impairment, and gut dysbiosis in obese individuals.
Detailed description
The duration of an individual's participation in the study was 45 days (15 days for the run-in period plus 30 days of intervention):
- Screening: Eligible participants were contacted through e-mail and invited to participate in a familiarization session in which detailed information about the study along with the consent statement form was presented. Participants who met the eligibility criteria and signed the consent were scheduled for screening visits. During the screening visits, the anthropometric (waist circumference, height, weight, and BMI) and wellness measurements (blood pressure, heart rate, and oxygen saturation) were measured.
- Run-in period: Participants were asked to complete a 2-week run-in period in which dietary supplements were removed from the diet while maintaining usual dietary patterns. During the run-in period, participants were asked to complete 24-hour dietary records for 5 days to have the baseline information related to their dietary patterns. In addition, participants were asked to reduce their intake of polyphenol and fiber-rich foods. After the completion of the 2-week run-in period, participants were allocated into cherry or placebo groups according to BMI, age, and gender and scheduled for study visits 1, 15, and 30.
- Intervention: During the 30-day cherry or placebo supplementation, participants were asked to maintain usual physical activity and diet, and to minimize the intake of foods high in polyphenol content. Nutritional habits were evaluated using 15-day dietary records collected on Myfitnesspal. Participants were instructed to drink a cherry juice or corresponding placebo twice a day for 30 days. At each study visit (study days 1, 15, and 30), wellness checks (blood pressure, heart rate, and oxygen saturation) and anthropometric measurements (body weight, height, % of body fat, body mass index (BMI), waist and hip circumference) were recorded. Biomarkers of inflammation, metabolic disorders, and liver health were assessed on blood samples collected on study days 1 and 30. Participants were instructed to fast for 12 h. before each study appointment and to drink plenty of water to facilitate blood draws. Blood fractions were aliquoted and stored at -80 C until analyses. The gut microbiota composition was assessed on stool samples collected on study days 1 and 30. Participants were given stool collection kits and instructed to avoid the use of laxatives, stool softeners, and antiacids within 48 hr. before stool collection. Participants were asked to bring their samples on study days 1 and 30 within 2 h. of collection or to freeze them if collected a day prior until transport to our facility. Stool samples received by the research personnel were immediately stored at -80 ⁰C until analysis. Intestinal permeability, which is a feature of intestinal barrier function, was evaluated through the lactulose/mannitol/sucralose test in urine samples collected on study days 1 and 30. This test was optional for participants. On study days 1 and 30, participants were given urine collection kits and instructed to collect their samples within 5 h of drinking a sugary solution containing lactulose, mannitol, and sucralose. Samples were stored at -20°C until analysis. Cognitive function was monitored on study days 1 and 30 through interviewer-administered tests that provided information on executive function skills (visual search, scanning, working memory, processing speed, and attention). In addition, visual cognitive performance was monitored during the last 15 days of the intervention using the Visual Cognitive Testing and Training: NeuroTracker™ CORE program (NT) from CogniSens Inc, which is a single-task integrative perceptual-cognitive training system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group 1: Obese adults (BMI: 30-40): 200 mL (~6.7 oz.) of dark sweet cherry (DSC) juice supplemented with 3g of DSC powder twice per day for 30 days. Group 2: Obese adults (BMI: 30-40): 200 mL (~6.7 oz.) of placebo juice twice per day for 30 days.
| Arm | Type | Receives |
|---|---|---|
| Cherry group | Experimental | Other: Cherry groupObese adults were asked to consume 200 mL of DSC juice supplemented with 3g of DSC powder twice / day for 30 days. |
| Placebo group | Experimental | Other: Placebo groupObese adults were asked to consume 200 mL of placebo juice supplemented twice / day for 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female at least 18 years old;
- No history of chronic diseases or intestinal disorders.
- BMI: ≥ 30 and ≤ 40.
Key exclusion criteria (13 listed)
- History of acute cardiac event, stroke, or cancer
- Alcohol or substance abuse within the last 6 months
- Recurrent admittance to the hospital (twice or more)
- Allergy, intolerance, or sensitivity to berries
- Hepatitis (B or C) or HIV
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 |
|---|---|---|
| Cherry group200 mL of DSC juice twice/day supplemented with 3g of DSC powder twice/day for 30 days | Other | Cherry group |
| Placebo group200 mL of placebo juice twice/day | Other | Placebo group |
Primary outcome
Change from baseline intestinal microbiota composition at 30 days
Time frame: At day 1 (baseline) and day 30
16S rRNA sequencing was used to evaluate the intestinal microbiota composition in stool samples collected on day 1 (baseline) and 30.
Change from baseline liver health biomarkers at 30 days
Time frame: At day 1 (baseline) and day 30
Liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase) levels were measured on fasting blood samples collected on day 1 and 30.
Change from cognitive function at 30 days
Time frame: At day 1 (baseline) and day 30
The trail making tests (A and B) were administered on day 1 and 30 to evaluate executive attention, and visual-spatial functions (visual search and scanning, sequencing).
Change from cognitive function at 30 days
Time frame: At day 1 (baseline) and day 30
The Digit Span tests (Forward and Backward) were administered on day 1 and 30 to evaluate working memory and concentration skills.
Change from cognitive function at 30 days
Time frame: At day 1 (baseline) and day 30
The Digit Span Substitution test was administered on days 1 and 30 to evaluate processing speed, sustained attention, and visual perception.
3 secondary outcomes
Change from baseline inflammatory biomarkers at 30 days
Time frame: At day 1 (baseline) and day 30.
Visual cognitive performance
Time frame: From day 15 to day 30.
Change from baseline lipid profile biomarkers at 30 days
Time frame: At day 1 (baseline) and day 30
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 19 Oct 2022.
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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 Phase 1 study testing Cherry group in people with Obesity, run by Texas A&M 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 3 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 19 Oct 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline intestinal microbiota composition at 30 days (time frame: At day 1 (baseline) and day 30). The study lists 5 primary outcomes in all. 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 19 Oct 2022.