Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students (FTGP2025)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale -14
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
freeze-dried table grape powder (FTGP)
Drink a daily supplement containing FTGP for 4 weeks
干预措施: freeze-dried table grape powder (Dietary Supplement)
Placebo
Drink a daily supplement containing a placebo for 4 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Hamilton Anxiety Scale -14
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- fecal short chain fatty acid(baseline (1st), week 4 (2nd) and week5 (3rd))
- Shannon Index of gut microbiota(baseline (1st), week 4 (2nd) and week5 (3rd))
- Beta diversity of gut microbiota(baseline (1st), week 4 (2nd) and week 5 (3rd))
研究者
Guojun Wu, Ph.D.
Assistant Research Professor
Rutgers, The State University of New Jersey