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| Name | Class |
|---|---|
| California Table Grape Commission | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| freeze-dried table grape powder (FTGP) | Experimental | Drink a daily supplement containing FTGP for 4 weeks |
|
| Placebo | Placebo Comparator | Drink a daily supplement containing a placebo for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| freeze-dried table grape powder | Dietary Supplement | 48g freeze-dried table grape powder/day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | baseline (1st), week 4 (2nd) and week5 (3rd) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline (1st), week 4 (2nd) and week5 (3rd) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guojun Wu | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Biochemistry and Microbiology, School of Environmental and Biological Sciences, Rutgers, The State University of New Jersey | New Brunswick | New Jersey | 08901 | United States |
IPD might not be shared according to the consent form.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2025 | Jan 5, 2026 | ICF_000.pdf |
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| Placebo | Dietary Supplement | 48g placebo/day for 4 weeks |
|
| 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. |
| 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 | baseline (1st), week 4 (2nd) and week5 (3rd) |