Gut Microbiota, Psychological Distress
Conditions
Keywords
Table grape, Gut Microbiota, psychological distress
Brief 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 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.
Interventions
DIETARY_SUPPLEMENTfreeze-dried table grape powder
48g freeze-dried table grape powder/day for 4 weeks
DIETARY_SUPPLEMENTPlacebo
48g placebo/day for 4 weeks
Sponsors
Rutgers, The State University of New Jersey
California Table Grape Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Anxiety Scale -14 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shannon Index of gut microbiota | baseline (1st), week 4 (2nd) and week5 (3rd) | 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. |
| Beta diversity of gut microbiota | baseline (1st), week 4 (2nd) and week 5 (3rd) | 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. |
| fecal short chain fatty acid | baseline (1st), week 4 (2nd) and week5 (3rd) | fecal short chain fatty acid will be measured by GC-MS |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGuojun Wu
Rutgers, The State University of New Jersey
Outcome results
None listed