NCT07043712进行中（未招募）不适用
Human Pulse Consumption, the Microbiome, and Meal Satiety
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
- 44
- 试验地点
- 1
- 主要终点
- gut microbial change
研究概览
简要总结
The purpose of the study is to investigate the effects of pulse consumption versus no pulse consumption on the gut microbiome, meal satiety, and short-chain fatty acid metabolomics.
详细描述
- Investigate the acute and chronic effects of pulse consumption on the microbiome and plasma SCFA metabolomics in overweight subjects fed a high pulse (n=22) diet versus a no pulse containing diet (n=22).
- Furthermore, we will quantitate the rate of production of plasma SCFA, markers of satiety (PYY, GLP-1 and ghrelin), blood lipids, and carbohydrate (CHO) metabolism (glucose levels and oxidation) during a standardized meal to determine the effects of consuming pulses on appetite and satiety after acute and chronic dietary consumption.
- We will conduct subjective appetite assessments to investigate appetite control over the short- and long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women (premenopausal only)
- •Age 20-55y (we will attempt to start baseline testing at the same time of the menstrual cycle (luteal) for the women
- •BMI ≥25 or ≤40 kg/m2 (most at risk for metabolic abnormalities and will benefit from a pulse intervention-2/3 of Americans are overweight or obese)
- •Weight stable (no fluctuations in body weight of greater than 4 kg in the last 3 months)
- •Willing to consume a research diet
- •Willing to provide blood and fecal samples
- •Sedentary to low active physical activity status (less than 7200 steps per day)
- •Stably treated with statin drugs, anti-hypertensives, and anti-depressants. These are acceptable as long as the drug category does not alter appetite, body weight, or the microbiome (if known)
- •Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c < 6.5%)
- •At least one characteristic of the metabolic syndrome (but not diabetic)
- •A large waistline: 35 inches or more for women 40 inches or more for men
- •High triglycerides: 150 mg/dL or higher
- •Low HDLc level: <50 mg/dL for women <40 mg/dL for men
- •High blood pressure ≥130/85 mmHg
- •Fasting blood sugar ≥100 mg/dL - Pre-diabetes acceptable (glucose <125 mg/dL or HbA1c <6.5%) -
排除标准
- •Pregnant or lactating
- •Postmenopausal (evidence suggests an interplay between the gut microbiome)
- •BMI of <25 or >40 kg/m2
- •Use of medications that affect the gut microbiome (e.g. antibiotics)
- •Taking medications known to affect appetite (e.g., phentermine) or gastrointestinal function (e.g., metformin)
- •On a special diet or undergoing weight loss, vegetarian, or other restricted dietary patterns
- •Ad libitum intake of fiber above 25g/day (mean intake in the US population is 17g/day) and < 10g/d
- •History of disease (example colon cancer, HIV, cardiovascular disease, psychiatric disorders, etc.)
- •Use of tobacco products
研究组 & 干预措施
High pulse consumption
Experimental
Subjects are provided a high pulse diet for 4-weeks. Tests include: blood biochemistries, a meal tolerance test, body composition measured via DEXA, surveys, fecal sample
干预措施: High pulse consumption (Dietary Supplement)
No pulse consumption
No Intervention
Subjects are provided a diet that has no pulses for 4-weeks. Tests include: blood biochemistries, a meal tolerance test, body composition measured via DEXA, surveys, fecal sample
结局指标
主要结局
gut microbial change
时间窗: baseline to 4 weeks
assessed via 16s rRNA gene sequencing from fecal samples collection
Change in appetite hormones
时间窗: baseline to 4 weeks
GLP-1 measurement in plasma samples
次要结局
- cardiometabolic risk factors(baseline to 4 weeks)
- Change in subjective appetite(baseline to 4 weeks)
- short chain fatty acid metabolomics(baseline to 4 weeks)
- Body composition(baseline to 4 weeks)
研究者
Katherene Anguah
Associate Professor, Nutrition and Exercise Physiology
University of Missouri-Columbia
研究点 (1)
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