Effects of Grape Consumption on Immune and Gut Health in the Setting of Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Gut microbial diversity
研究概览
简要总结
This study is investigating the benefits of whole freeze-dried grape powder consumption on the immune-gut axis in adults with obesity.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Study food allergies
- •Regular consumption of grapes or grape-derived products
- •Gastrointestinal disease and/or bariatric surgery
- •Uncontrolled hypertension and blood pressure >180/110
- •Illicit drug use
- •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
研究组 & 干预措施
Sequence 1: Grape then Placebo
Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks.
干预措施: Freeze-dried grape powder (Other)
Sequence 1: Grape then Placebo
Whole freeze-dried grape powder for 4 weeks, 4-week washout, then isocaloric placebo powder for 4 weeks.
干预措施: Placebo powder (Other)
Sequence 2: Placebo then Grape
Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks.
干预措施: Freeze-dried grape powder (Other)
Sequence 2: Placebo then Grape
Isocaloric placebo powder for 4 weeks, 4-week washout, then whole freeze-dried grape powder for 4 weeks.
干预措施: Placebo powder (Other)
结局指标
主要结局
Gut microbial diversity
时间窗: Baseline, Week 4, Week 8, Week 12
Assessed via 16s rRNA sequencing
LPS-binding protein concentration
时间窗: Baseline, Week 4, Week 8, Week 12
Intestinal permeability marker
Cytokine concentrations following PBMC stimulation
时间窗: Baseline, Week 4, Week 12
IL-6, IL-10
Perceived stress score
时间窗: 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.
次要结局
- Gut microbiome abundance(Baseline, Week 4, Week 8, Week 12)
- Inflammatory Markers(Baseline, Week 4, Week 8, Week 12)
- Body mass(Baseline, Week 4, Week 8, Week 12)
- Body composition(Baseline, Week 4, Week 8, Week 12)
- Anthropometrics(Baseline, Week 4, Week 8, Week 12)
- Glucoregulation(Baseline, Week 4, Week 8, Week 12)
- Insulinemic biomarker concentrations(Baseline, Week 4, Week 8, Week 12)
- Lipid profile(Baseline, Week 4, Week 8, Week 12)
- Blood pressure(Baseline, Week 4, Week 8, Week 12)
- Dietary intake using 24-hour recalls(Every week)
- Physical activity(Baseline, Week 4, Week 8, Week 12)
- Sleep indices from Actigraphs(Baseline, Week 4, Week 8, Week 12)
- 24-hour appetite ratings(Baseline, Week 4, Week 8, Week 12)
- Palatability rating of foods(Every week)
- Acceptance rating of foods(Every week)
- Dietary Intake over past month(Baseline, Week 4, Week 8, Week 12)
- IPAQ Score(Baseline, Week 4, Week 8, Week 12)
- Sleep indices from sleep diary(Baseline, Week 4, Week 8, Week 12)
研究者
Jaapna Dhillon
Assistant Professor
University of Missouri-Columbia