NCT06227494进行中（未招募）不适用
Dietary Fiber: Is it the Missing Link in Achieving Long Term Behavior Change?
适应症
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
- 63
- 试验地点
- 1
- 主要终点
- Body weight
研究概览
简要总结
The overall objective of this three-arm randomized controlled trial is to compare a dietary fiber-focused behavioral intervention to standard weight loss education for improving eating-related behavior and cognition, weight, and metabolic markers of chronic disease risk in a population of adults with obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-65 years of age
- •Dietary fiber intake ≤25 grams/day
- •Self-reported BMI ≥30 kg/m2
- •Willingness to attend in-person education sessions
- •Willingness to avoid taking supplemental digestive aids (e.g., alpha-galactosidase (Beano®),
- •Willingness to provide informed consent.
排除标准
- •Metabolic, digestive, or allergic conditions or reactions that preclude consumption of whole food or food groups (e.g., irritable bowel syndrome, diverticulosis)
- •History of gastric bypass surgery
- •Currently taking glucagon like glucagon-like peptide-1 (GLP-1) Receptor Agonists
- •Self-reported history of a diagnosed eating disorder
- •Chronic disease (other than obesity)
- •Pregnancy or lactation
- •Use of tobacco or electronic smoking products
- •Taking a pre-, pro-, or syn-biotic supplement
- •Enrollment in another weight loss or diet intervention
研究组 & 干预措施
Fiber Intervention
Experimental
Individuals in this arm will be given instruction on how to increase fiber intake,
干预措施: Fiber Intervention (Behavioral)
Standard Weight Loss Education
Active Comparator
Individuals in this arm will be given standard weight loss education
干预措施: Standard Weight Loss Education (Behavioral)
Fiber Intervention + Standard Weight Loss Education
Experimental
Individuals in this arm will be given education on both fiber and standard weight loss
干预措施: Fiber Intervention (Behavioral)
Fiber Intervention + Standard Weight Loss Education
Experimental
Individuals in this arm will be given education on both fiber and standard weight loss
干预措施: Standard Weight Loss Education (Behavioral)
结局指标
主要结局
Body weight
时间窗: Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27)
Measure of body weight/mass
次要结局
- Total Cholesterol(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Fecal bacteria measured using 16S ribosomal ribonucleic acid (rRNA) sequencing(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Fasting blood glucose(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 33, month 27))
- Executive Function: Tower Test (Delis-Kaplan Executive Function System)(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Low-density lipoprotein (LDL) cholesterol(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Body composition (fat mass, lean mass)(Measured at baseline (time 1, month 0) and post-observation (time 3, month 27))
- Three-Factor Eating Questionnaire(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Implicit Association Test(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Behavioral Inhibition System/Behavioral Approach System (BIS/BAS) Scale(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Executive Function: Color-Word Interference Test (Delis-Kaplan Executive Function System)(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Skin Carotenoid scores measured via the Veggie Meter(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- High-density lipoprotein (HDL) cholesterol(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Fecal short chain fatty acids(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
- Healthy Eating Index Scores measured using Health Eating Index 2020 (HEI-2020)(Measured at baseline (time 1, month 0), post-intervention (time 2, month 15), and post-observation (time 3, month 27))
研究者
研究点 (1)
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