Dietary Incorporation of Lentils to Improve Metabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Glucose Tolerance
研究概览
简要总结
Approximately 40% of Americans are pre-diabetic or diabetic, mostly in the form of type 2 diabetes (T2D), which is heavily influenced by diet. Three interrelated factors driving the progression of T2D are large glycemic and lipidemic responses after a meal, consumption of excess calories, and increased fat within the abdominal compartment, referred to as visceral adipose tissue (VAT). Available research suggests that these problems may be attenuated with pulse consumption both at the time of consumption and at the next meal, in what is referred to as the second meal effect. Associations between pulse consumption and metabolic health have been measured in observational studies; unfortunately, randomized clinical trials data to establish cause and effect in humans are typically short in duration (≤ 4 weeks), limited to a single dose of pulse consumption (none exclusively for lentils), and not designed to strategically exploit the well-established second meal effect. We expect the impact of lentil intake will be greatest if consumed at the midday meal to offset the magnitude of the response to the large caloric intake typical in the evening. Our overarching hypothesis is that midday lentil consumption in individuals at greater risk for metabolically driven diseases will improve metabolic health. The purpose of this proposal is to determine whether eight weeks of 0, 300, or 600 grams per week of lentils by individuals with elevated VAT will improve insulin sensitivity, hepatic insulin resistance, lipid profiles (total cholesterol, triglycerides, LDL and HDL lipoproteins), inflammation, appetite and satiety, body mass, body composition, and volume of VAT.
详细描述
Investigators utilized a parallel intervention of two separate dietary lentil doses versus control (no lentils) treatments for eight weeks in adults with elevated waist circumference. Enrolled participants were randomized to LOW (300 g lentils/week), HIGH (600 g lentils/week), or CONTROL (0 g lentils/week) treatment groups using block randomization. Outcome variables were assessed before and after 8 weeks of the dietary intervention.
Procedures:
Anthropometrics. Measurements were collected from participants before and after the intervention using the validated segmental multifrequency bioelectrical impedance analysis (SECA mBCA515, Hamburg, Germany) (cite). Fat mass (%) and estimated visceral adipose (L) were used for analysis.
Glycemic Challenge. An oral glucose tolerance test (OGTT) was administered as a meal which contained white bread containing 75 g or available carbohydrate. Water was provided with the meal. Caffeinated black tea was provided for participants who identified as habitual morning caffeine consumers. Participants were instructed to avoid alcohol consumption and strenuous physical activity in the 24 hours before their visit and to complete an overnight fast (10 -12 hours) before blood collection. Fasting blood samples were collected by venipuncture by a trained phlebotomist before ingestion of the glycemic challenge meal. A fingerstick was used to obtain blood for glucose and insulin prior to ingestion of bread and every 30 minutes in the 2-hour postprandial period.
Dietary Intervention: Experimental diets were provided to participants in the form of five pre-made midday meals containing 0, 60, or 120 g per meal matched across treatment groups for total energy and protein. Midday meals were targeted in this study to exploit the second meal effect of lower caloric intake at the next meal, the evening meal. Participants were instructed to consume all of the meal provided to them at the midday meal and then proactively reduce portion sizes and not eat beyond fullness at the evening meal. Participants were instructed to eat the meals Monday through Friday, and to eat any missed meals on Saturday or Sunday. Compliance was checked with random emails once per week and verbal reporting when picking up weekly meals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI = or > than 27 kg/m^2
- •Waist circumference > 35 inches for women and > 40 inches for men
排除标准
- •Allergy to wheat
- •Taking medication that will influence glucose, cholesterol, lipids, or inflammation
- •Having a pacemaker
- •Other health conditions that may interfere with study outcomes
- •Planning a weight loss or change in exercise regimen
结局指标
主要结局
Glucose Tolerance
时间窗: Week 8
Blood glucose area under the curve during 2-h 75 g oral glucose tolerance (units = mmol/2 h)
Body Mass
时间窗: Week 8
Total body mass (units = kg)
Insulin Response During Glucose Tolerance Test
时间窗: Week 8
Serum insulin area under the curve during 2-h 75 g oral glucose tolerance test (units = pmol/2 h)
Satiety during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How satisfied do you feel?"(Ordinal scale ratings from 0 = not at all, 10 = extremely). Higher rating of satiety is a better outcome.
Gastrointestinal Comfort during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective ratings of level of flatulance, bloating, cramping, and abdominal discomfort participants experienced after eating study meals. (Ratings = none, mild, moderate, severe)
Appetite during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How much do you think you could (or would want to) eat right now?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of appetite is a better outcome.
Visceral Adipose Tissue
时间窗: Week 8
Volume of adipose tissue within the abdominal compartment (units = liters)
Fullness during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How full are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Higher rating of fullness is a better outcome.
Serum Metabolome
时间窗: Week 8
Serum metabolites (untargeted) measured from fasting serum (units can be either mmol or area under the curve)
Hunger during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How hungry are you?" (Ordinal scale ratings from 0 = not at all to 10 = extremely). Lower rating of hunger is a better outcome.
Desire to Eat during the 8-week Intervention
时间窗: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8
Subjective rating at 4:00 pm in response to the question: "How strong is your desire to eat?" (Ordinal scale ratings from 0 = nothing to 10 = very large amount). Lower rating of desire to eat is a better outcome.
次要结局
- C-reactive protein(Week 8)
- Inflammatory cytokines(Week 8)
- Fasting lipid panel(Week 8)
- Fasting glucose(Week 8)