NCT07219706进行中（未招募）不适用
Examining the Independent and Combined Effects of Dietary Fiber and Time Restricted Eating on Indicators of Cancer Risk: the Fiber and Time Restricted Eating (F.I.T.) Study
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Dietary fiber intake
研究概览
简要总结
This study is seeking to examine combinations of two different dietary interventions on cancer risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥30 kg/m2
- •Dietary fiber intake ≤15 g/day
- •Compatible cell phone for use of ecological momentary assessment app
排除标准
- •Self-reported diagnosis that precludes fiber intake (e.g., inflammatory bowel disease)
- •Food allergies or intolerances that limit ability to engage with the intervention
- •Positive screen on the SCOFF eating disorder screener39
- •Current self-reported use of GLP-1 receptor agonists
- •Currently pregnant or breastfeeding, or planning to become pregnant
研究组 & 干预措施
Fiber for Improvement of Behavior, Eating, and Risk (FIBER)
Experimental
干预措施: Group education (Behavioral)
FIBER and TRE
Experimental
干预措施: Group education (Behavioral)
FIBER and TRE
Experimental
干预措施: Counseling (Behavioral)
Fiber for Improvement of Behavior, Eating, and Risk (FIBER)
Experimental
干预措施: Counseling (Behavioral)
Time Restricted Eating (TRE)
Experimental
干预措施: Time Restricted Eating (Behavioral)
FIBER and TRE
Experimental
干预措施: Time Restricted Eating (Behavioral)
结局指标
主要结局
Dietary fiber intake
时间窗: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Dietary fiber intake as reported on 3-day diet records and analyzed according to Nutrition Data System for Research; reported as a mean intake over three days in grams per day
次要结局
- Body mass/weight(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood pressure(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood-based measures of inflammation(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood-based measures of oxidative stress(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Affect(Daily for three months)
- Sleep(Daily for three months)
- Body mass/weight(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood pressure(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood-based measures of inflammation(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood-based measures of oxidative stress(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Blood-based measures of insulin resistance(Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months))
- Affect(Daily for three months)
- Sleep(Daily for three months)
- Physical Activity(Daily for three months)
研究者
研究点 (1)
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