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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Texas A&M University

    College Station, Texas, 77845

Other trials in United States

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 groups in NCT05586386
Study groupRoleWhat they receive
Cherry groupExperimentalObese 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 groupExperimentalObese 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)
  1. 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.

  2. 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.

  3. 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.

  1. First posted19 Oct 2022
  2. Study start6 Feb 2020
  3. Primary completion20 Sep 2021
  4. Study completion20 Sep 2021

Resources

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)
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

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.

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