Obesity &Amp; OverweightNCT07231484
Effects of Grape Consumption on the Immune-Gut Axis in Obesity
A study testing Freeze-dried grape powder in people with Obesity &Amp; Overweight, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity &Amp; Overweight
- What is being tested?
- Freeze-dried grape powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years
- Obesity with BMI of 30-45 kg/m2
- Willingness to consume study foods
- Consistent diet and activity patterns for 4 weeks
- Weight stable (<5kg change over last 3 months)
- Non-smoker > 1 year or more
- Not currently consuming an extremely healthy diet
Who cannot join
- Study food allergies
- Regular consumption of grapes or grape-derived products
- Gastrointestinal disease and/or bariatric surgery
- Uncontrolled hypertension and blood pressure >180/110
- Diabetes
- Illicit drug use
Show all 13Show fewer
- History of alcohol or drug abuse
- Recent use of medications that affect immune function (e.g., corticosteroids)
- Recent consumption of antibiotics, prebiotics, probiotics, symbiotics, or dietary supplements containing fiber or phytochemicals
- Pregnant or lactating individuals
- HIV positivity
- Recent start of medications that affect metabolism or appetite
- Drug therapy for coronary artery disease, peripheral artery disease, congestive
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri-Columbia
Columbia, Missouri, 65211
Caitlyn Winn, MS, 2072108049, cawq6x@umsystem.edu
Jaapna Dhillon, PhD
About this study
Official title: Effects of Grape Consumption on Immune and Gut Health in the Setting of Obesity
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Read the detailed description
The study is a 12-wk randomized, controlled, crossover trial. Participants will be randomized to one of two intervention sequences, either consuming 48g/day of whole freeze-dried grape powder followed by an isocaloric placebo powder or consuming the placebo powder followed by the whole freeze-dried grape powder. Active intervention phases will be 4 weeks in duration followed by a 4-week washout period between treatments.
- Conditions
- Obesity &Amp; Overweight
- Being tested
- Freeze-dried grape powder, Placebo powder
- Keywords
- Obesity, Immunity, Microbiome, Gut, Grape, Stress
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried grape powderOther
48 g/day oral consumption during the 4-week active period.
Placebo powderOther
Isocaloric placebo matched to grape powder; oral consumption during the 4-week active period.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Grape then Placebo | Experimental | Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks. Receives: Other: Freeze-dried grape powder; Other: Placebo powder |
| Sequence 2: Placebo then Grape | Experimental | Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks. Receives: Other: Freeze-dried grape powder; Other: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbial diversity
Assessed via 16s rRNA sequencing
Measured: Baseline, Week 4, Week 8, Week 12
LPS-binding protein concentration
Intestinal permeability marker
Measured: Baseline, Week 4, Week 8, Week 12
Cytokine concentrations following PBMC stimulation
IL-6, IL-10
Measured: Baseline, Week 4, Week 12
Perceived stress score
Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (18)
Gut microbiome abundance
Assessed via 16s rRNA sequencing
Measured: Baseline, Week 4, Week 8, Week 12
Inflammatory Markers
IL-6, IL-10, TNF-alpha, IFN-gamma
Measured: Baseline, Week 4, Week 8, Week 12
Body mass
Measured in kg
Measured: Baseline, Week 4, Week 8, Week 12
Body composition
Fat mass and fat-free mass
Measured: Baseline, Week 4, Week 8, Week 12
Anthropometrics
Waist circumference, hip circumference, thigh circumference
Measured: Baseline, Week 4, Week 8, Week 12
Glucoregulation
Fasting glucose concentrations
Measured: Baseline, Week 4, Week 8, Week 12
Insulinemic biomarker concentrations
Insulin concentrations
Measured: Baseline, Week 4, Week 8, Week 12
Lipid profile
LDL, HDL, triglycerides, total cholesterol
Measured: Baseline, Week 4, Week 8, Week 12
Blood pressure
Diastolic and systolic blood pressure
Measured: Baseline, Week 4, Week 8, Week 12
Dietary intake using 24-hour recalls
24-hour diet recall using Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA-24).
Measured: Every week
Physical activity
Activity assessment using Actigraphs
Measured: Baseline, Week 4, Week 8, Week 12
Sleep indices from Actigraphs
Assessed using Actigraphs
Measured: Baseline, Week 4, Week 8, Week 12
24-hour appetite ratings
24-hour appetite ratings assessed using Visual Analog Scale. For each question scores range from 0-100 with higher scores indicating "extremely" and lower scores indicating "not at all."
Measured: Baseline, Week 4, Week 8, Week 12
Palatability rating of foods
Hedonic general labelled magnitude scale (gLMS). Scores range from 0 to 100.
Measured: Every week
Acceptance rating of foods
9-point food action rating scale (1-9) with higher scores indicating a higher food rating.
Measured: Every week
Dietary Intake over past month
Assessed using Food Frequency Questionnaires
Measured: Baseline, Week 4, Week 8, Week 12
IPAQ Score
Measured using the International Physical Activity Questionnaire (IPAQ). Activity levels categorized as high, moderate, or low based on IPAQ scoring procedure.
Measured: Baseline, Week 4, Week 8, Week 12
Sleep indices from sleep diary
Assessed using sleep diary
Measured: Baseline, Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start19 Dec 2025
- Primary completion20 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity &Amp; OverweightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Principal investigator, Jaapna Dhillon, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231484
- Sponsor's protocol ID
- 2128808
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Grape Consumption on Immune and Gut Health in the Setting of Obesity
- ClinicalTrials.gov ID
- NCT07231484
- Acronym / sponsor ID
- 2128808
- Conditions
- Obesity &Amp; Overweight
- Keywords
- Obesity, Immunity, Microbiome, Gut, Grape, Stress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Nov 2025 (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.
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
Detailed description
The study is a 12-wk randomized, controlled, crossover trial. Participants will be randomized to one of two intervention sequences, either consuming 48g/day of whole freeze-dried grape powder followed by an isocaloric placebo powder or consuming the placebo powder followed by the whole freeze-dried grape powder. Active intervention phases will be 4 weeks in duration followed by a 4-week washout period between treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Grape then Placebo | Experimental | Other: Freeze-dried grape powder, Other: Placebo powderWhole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks. |
| Sequence 2: Placebo then Grape | Experimental | Other: Freeze-dried grape powder, Other: Placebo powderIsocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: 18-60 years
- Obesity with BMI of 30-45 kg/m2
- Willingness to consume study foods
- Consistent diet and activity patterns for 4 weeks
- Weight stable (<5kg change over last 3 months)
Key exclusion criteria (13 listed)
- Study food allergies
- Regular consumption of grapes or grape-derived products
- Gastrointestinal disease and/or bariatric surgery
- Uncontrolled hypertension and blood pressure >180/110
- Diabetes
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 |
|---|---|---|
| Freeze-dried grape powder48 g/day oral consumption during the 4-week active period. | Other | Sequence 1: Grape then Placebo, Sequence 2: Placebo then Grape |
| Placebo powderIsocaloric placebo matched to grape powder; oral consumption during the 4-week active period. | Other | Sequence 1: Grape then Placebo, Sequence 2: Placebo then Grape |
Primary outcome
Gut microbial diversity
Time frame: Baseline, Week 4, Week 8, Week 12
Assessed via 16s rRNA sequencing
LPS-binding protein concentration
Time frame: Baseline, Week 4, Week 8, Week 12
Intestinal permeability marker
Cytokine concentrations following PBMC stimulation
Time frame: Baseline, Week 4, Week 12
IL-6, IL-10
Perceived stress score
Time frame: Baseline, Week 4, Week 8, Week 12
Assessed using validated Cohen's Perceived Stress Scale. Scores range from 0-56 with higher scores indicating greater stress perceptions.
18 secondary outcomes
Gut microbiome abundance
Time frame: Baseline, Week 4, Week 8, Week 12
Inflammatory Markers
Time frame: Baseline, Week 4, Week 8, Week 12
Body mass
Time frame: Baseline, Week 4, Week 8, Week 12
Body composition
Time frame: Baseline, Week 4, Week 8, Week 12
Anthropometrics
Time frame: Baseline, Week 4, Week 8, Week 12
Glucoregulation
Time frame: Baseline, Week 4, Week 8, Week 12
Insulinemic biomarker concentrations
Time frame: Baseline, Week 4, Week 8, Week 12
Lipid profile
Time frame: Baseline, Week 4, Week 8, Week 12
Blood pressure
Time frame: Baseline, Week 4, Week 8, Week 12
Dietary intake using 24-hour recalls
Time frame: Every week
Physical activity
Time frame: Baseline, Week 4, Week 8, Week 12
Sleep indices from Actigraphs
Time frame: Baseline, Week 4, Week 8, Week 12
24-hour appetite ratings
Time frame: Baseline, Week 4, Week 8, Week 12
Palatability rating of foods
Time frame: Every week
Acceptance rating of foods
Time frame: Every week
Dietary Intake over past month
Time frame: Baseline, Week 4, Week 8, Week 12
IPAQ Score
Time frame: Baseline, Week 4, Week 8, Week 12
Sleep indices from sleep diary
Time frame: Baseline, Week 4, Week 8, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried grape powder in people with Obesity &Amp; Overweight, run by University of Missouri-Columbia 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 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaapna Dhillon PhD, PhD (573-884-2103, jdhillon@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbial diversity (time frame: Baseline, Week 4, Week 8, Week 12). The study lists 4 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 31 Jul 2026.