Gut MicrobiotaNCT07214428
Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students
A study testing freeze-dried table grape powder in people with Gut Microbiota and Psychological Distress, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are: Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Psychological Distress
- What is being tested?
- freeze-dried table grape powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2025to 31 Dec 2026
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-30 years old
- Able to give written informed consent.
- BMI 18.5-24.9 kg/m2
- Healthy (self-reported)
- Can read and speak English
Who cannot join
- Currently taking medications that interfere with polyphenol
- Currently using or have used antibiotics continuously for >3 days within 3 months prior to enrollment
- Have had surgery involving the intestinal lumen within the last 30 days
- Have a documented diagnosis of celiac disease or/and inflammatory bowel diseases
- Are pregnant or breastfeeding
- Have prediabetes and diabetes
Show all 12Show fewer
- Have had bariatric surgery
- Are immunocompromised ( e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, or poorly controlled HIV/AIDS)
- Are unable to provide consent
- Are hospitalized,
- Have a history of or current alcohol, drug, or medication abuse (self-reported),
- Have contraindication to any substance in the investigational product or who are currently enrolled in other interventional trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Biochemistry and Microbiology, School of Environmental and Biological Sciences, Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students (FTGP2025)
The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are:
Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota.
Participants will:
Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.
- Conditions
- Gut Microbiota, Psychological Distress
- Being tested
- freeze-dried table grape powder, Placebo
- Keywords
- Table grape, Gut Microbiota, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
freeze-dried table grape powderDietary supplement
48g freeze-dried table grape powder/day for 4 weeks
PlaceboDietary supplement
48g placebo/day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| freeze-dried table grape powder (FTGP) | Experimental | Drink a daily supplement containing FTGP for 4 weeks Receives: Dietary Supplement: freeze-dried table grape powder |
| Placebo | Placebo comparator | Drink a daily supplement containing a placebo for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Scale -14
HAMA-14 is one of the earliest and most widely used clinical scales for measuring the severity of a patient's anxiety. It has 14 items, each reflecting a cluster of anxiety symptoms. Total range: 0 to 56, with higher scores indicating greater severity of anxiety
Measured: baseline (1st), week 4 (2nd) and week 5 (3rd)
17-item of Hamilton Depression Rating Scale
HAMD-17 is one of the most widely used clinician-administered scales for measuring the severity of a patient's depression. It has 17 items, each covering symptoms of depression across mood, physical, and cognitive domains. With higher scores indicating greater severity of depression.
Measured: baseline (1st), week 4 (2nd) and week5 (3rd)
10-item of Perceived Stress Scale
PSS-10 is one of the most widely used psychological instruments for measuring the perception of stress. It has 10 items, each reflecting how unpredictable, uncontrollable, and overloaded respondents find their lives during the past month. Total range: 0 to 40, with higher scores indicating greater perceived stress.
Measured: baseline (1st), week 4 (2nd) and week5 (3rd)
Secondary outcomes (3)
Shannon Index of gut microbiota
Changes in gut microbiota will be assessed from stool samples using 16S rRNA gene sequencing. Alpha diversity will be calculated using Shannon Index. This measure will characterize whether the intervention alters gut microbial diversity in each subject.
Measured: baseline (1st), week 4 (2nd) and week5 (3rd)
Beta diversity of gut microbiota
Changes in gut microbiota will be assessed from stool samples using 16S rRNA gene sequencing. Beta diversity will be calculated using Bray Curtis distance between samples. This measure will characterize whether and how the intervention alters gut microbial communities.
Measured: baseline (1st), week 4 (2nd) and week 5 (3rd)
fecal short chain fatty acid
fecal short chain fatty acid will be measured by GC-MS
Measured: baseline (1st), week 4 (2nd) and week5 (3rd)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start20 Oct 2025
- Primary completion24 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- California Table Grape Commission
- Responsible party
- Principal investigator, Guojun Wu, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Guojun Wu, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214428
- Sponsor's protocol ID
- Pro2025001394
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might not be shared according to the consent form.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students (FTGP2025)
- ClinicalTrials.gov ID
- NCT07214428
- Acronym / sponsor ID
- Pro2025001394
- Conditions
- Gut Microbiota, Psychological Distress
- Keywords
- Table grape, Gut Microbiota, psychological distress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- California Table Grape Commission
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 24 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Oct 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.
The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are:
Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota.
Participants will:
Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| freeze-dried table grape powder (FTGP) | Experimental | Dietary Supplement: freeze-dried table grape powderDrink a daily supplement containing FTGP for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDrink a daily supplement containing a placebo for 4 weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 18-30 years old
- Able to give written informed consent.
- BMI 18.5-24.9 kg/m2
- Healthy (self-reported)
- Can read and speak English
Key exclusion criteria (12 listed)
- Currently taking medications that interfere with polyphenol
- Currently using or have used antibiotics continuously for >3 days within 3 months prior to enrollment
- Have had surgery involving the intestinal lumen within the last 30 days
- Have a documented diagnosis of celiac disease or/and inflammatory bowel diseases
- Are pregnant or breastfeeding
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 table grape powder48g freeze-dried table grape powder/day for 4 weeks | Dietary supplement | freeze-dried table grape powder (FTGP) |
| Placebo48g placebo/day for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Hamilton Anxiety Scale -14
Time frame: baseline (1st), week 4 (2nd) and week 5 (3rd)
HAMA-14 is one of the earliest and most widely used clinical scales for measuring the severity of a patient's anxiety. It has 14 items, each reflecting a cluster of anxiety symptoms. Total range: 0 to 56, with higher scores indicating greater severity of anxiety
17-item of Hamilton Depression Rating Scale
Time frame: baseline (1st), week 4 (2nd) and week5 (3rd)
HAMD-17 is one of the most widely used clinician-administered scales for measuring the severity of a patient's depression. It has 17 items, each covering symptoms of depression across mood, physical, and cognitive domains. With higher scores indicating greater severity of depression.
10-item of Perceived Stress Scale
Time frame: baseline (1st), week 4 (2nd) and week5 (3rd)
PSS-10 is one of the most widely used psychological instruments for measuring the perception of stress. It has 10 items, each reflecting how unpredictable, uncontrollable, and overloaded respondents find their lives during the past month. Total range: 0 to 40, with higher scores indicating greater perceived stress.
3 secondary outcomes
Shannon Index of gut microbiota
Time frame: baseline (1st), week 4 (2nd) and week5 (3rd)
Beta diversity of gut microbiota
Time frame: baseline (1st), week 4 (2nd) and week 5 (3rd)
fecal short chain fatty acid
Time frame: baseline (1st), week 4 (2nd) and week5 (3rd)
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 11 Aug 2026.
- Individual participant dataSharing planned: No. IPD might not be shared according to the consent form.
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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.
Guojun Wu principal investigator
Rutgers, The State University of New Jersey
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 table grape powder in people with Gut Microbiota and Psychological Distress, run by Rutgers, The State University of New Jersey 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 12 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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. Some participants in this study may receive a placebo. 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?
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?
Hamilton Anxiety Scale -14 (time frame: baseline (1st), week 4 (2nd) and week 5 (3rd)). The study lists 3 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 11 Aug 2026.