Effects of Proportioning Meat and Plant-based Protein-rich Foods Within the U.S. Healthy Eating Pattern on Cardiovascular Disease Risk Factors (S58)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Risk factors for cardiovascular disease
研究概览
简要总结
This project will assess the effects of consuming different proportions of red meat (RM) and plant-based, protein-rich foods (nuts, seeds, and soy products - NSS) incorporated into a U.S. Healthy Eating Pattern (HEP) on cardiovascular disease risk factors in adults at high risk of developing a heart-related disease.
详细描述
Using a randomized, cross-over (balanced incomplete block) experimental design, Forty-eight middle-aged adults who are overweight and have high blood total cholesterol and LDL-C concentrations will be recruited. Participants will consume a HEP - all foods provided - during 5-week controlled feeding periods. The three HEP interventions will be: high RM, low NSS; moderate RM, moderate NSS; and low RM, high NSS. Each participant will complete two of the three controlled feeding periods, separated by four weeks when participants will consume their usual unrestricted diet (washout). The HEP consumed during the controlled feeding periods will be the same except for the amounts of RM (1, 5, or 9, 3-oz servings/wk) and NSS (high, moderate, and low, with amounts adjusted to isocalorically offset changes in RM energy intakes). Poultry, egg, and legume intakes will be the same among the three HEP. The investigators will measure clinically important cardiovascular disease risk factors before (usual unrestricted diet) and during the last week of each HEP intervention. The cardiovascular disease risk factors will include, but are not limited to, comprehensive lipid and lipoprotein profile (changes in low-density lipoprotein cholesterol, LDL-C; primary outcome), lipoprotein fractionation and particle numbers, and blood pressure. The investigators will compare improvements in heart disease risk factors and consumer satisfaction among the three HEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female;
- •Age 30-69 y;
- •BMI: 25.0-37 kg/m2;
- •Have hypercholesterolemia (total and LDL cholesterol 200-259 and 130-189 mg/dL, respectively),
- •Systolic/diastolic blood pressure <140/90 mm Hg;
- •Triglycerides <399 mg/dL, fasting glucose <109 mg/dL
- •Body weight stable for 3 months prior (±3 kg);
- •Stable physical activity regimen 3 months prior;
- •Medication use stable for 6 months prior;
- •Non-smoking;
- •Non-diabetic;
- •Not acutely ill;
- •Females not pregnant or lactating;
- •Participants must be willing and able to consume the prescribed diets and travel to testing facilities.
排除标准
- •BMI <25 or >37
- •Total cholesterol >259 mg/dL, low-density lipoprotein cholesterol >189 mg/dL,
- •Triglycerides >400 mg/dL, fasting glucose >110 mg/dL
- •Body weight changes in previous 3 months (±3 kg)
- •Changes in physical activity regimen in the previous 3 months
- •Medication changes in the previous 6 months
- •Acute illness
- •Pregnant or lactating
结局指标
主要结局
Risk factors for cardiovascular disease
时间窗: 5 weeks
Lipoprotein Particle Plus (LPP+) Panel. This comprehensive lipid panel will provide us with lipoprotein fractionation and particle number (VLDL, non-HDL, remnant lipoprotein, small/dense LDL III and IV, total measured HDL and LDL, and large buoyant HDL 2b), homocysteine, insulin, apolipoprotein A1, total apolipoprotein B, lipoprotein a, high sensitivity C-reactive protein, and a traditional lipid panel (total cholesterol, HDL cholesterol, calculated LDL cholesterol, triglycerides)
次要结局
- Body weight(Measures will be taken twice per week throughout the entire enrollment period (15 weeks))
- Change in consumer perception and satisfaction of the HEPs(5 weeks)
- Risk factors for cardiometabolic disease(5 weeks)
- Risk factors for cardiovascular disease(5 weeks)
研究者
Wayne Campbell
Principal Investigator
Purdue University