The Role of Lean-pork Within a Plant-based Dietary Pattern for Improving Iron Reserve, Muscle-fitness, and Markers of Health Span in Older Adults: A Multi-disciplinary Randomized Controlled Feeding Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Concentration of Fasting insulin in blood
研究概览
简要总结
The central hypothesis is that the addition of minimally processed lean pork to a healthy plant-forward low ultra-processed diet will enhance nutrient adequacy, promote muscular fitness, and maintain metabolic functions for improved healthspan. A well-designed, randomized, controlled, crossover, feeding study with clinical and molecular mechanistic endpoints is proposed to provide the most definitive level of evidence logistically possible in humans and to establish the role of minimally processed lean pork in healthspan promotion. Utilizing an all-food-provided (dine-in and take-out) design over 18 weeks (rolling recruitment, 8+8, 2w washout), a comprehensive assessment of metabolomics, system biology, physical, and physiological markers that indicate the risk of age-related comorbidities-critical micronutrient deficiency, frailty, metabolic dysfunctions, and cognitive decline, is proposed in upper Midwesterners 65 years and older. A minimally processed plant-forward diet with or without added pork will be compared for over 250 outcome measures using mixed-effects modeling adjusting for covariates in R. n=15/diet/arm i.e., a total starting sample size of n=30 is proposed for 90% power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Blinding will be implemented to the extent possible. A researcher, unaware of the study goals and not involved with downstream data analyses will use a 1:1 block randomization to allocate participants to the diets in the first arm. Food service personnel (care provider) will not be aware of study goals and allocations. Metabolomic assays will be run in a blinded manner.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Generally good health status based on one routine physical in the past 15 months
- •Normal HbA1C, weigh 110 lb or more
- •Age 65 years or more, generally healthy, all races and both sexes
- •Generally practicing a meat-based dietary pattern, do not have any special dietary requirement
- •Willingness to comply with the study protocol, including on-site meal consumption and sample/data collection.
- •Willing to consume pork as sole meat source during the feeding study.
排除标准
- •Tobacco/drug/alcohol use
- •Not on any special diet within 3 months of recruitment, and do not have any intention to lose weight.
- •Active history of cancer, diabetes, heart, liver, and kidney diseases
- •major gastrointestinal disorders in the past 3 months
- •history of heart attacks or stroke
- •Unable to meet in-person visit requirements for dining, picking up meals, and tests
- •Any mental health condition that would affect the ability to provide written informed consent.
- •If they were unwilling to abstain from taking certain nutritional supplements, alcohol, or non-study foods during the study period.
结局指标
主要结局
Concentration of Fasting insulin in blood
时间窗: Time frame: 16 weeks
Using Microplate assay
Concentration of Ferritin in blood
时间窗: Time frame: 16 weeks
Using Microplate assay
Concentration of Homocysteine in blood
时间窗: Time frame: 16 weeks
Using Microplate assay
Frequency of Sit-to-stand for strength assessment
时间窗: Time frame: 16 weeks
Functional assessment test
次要结局
- Body Weight in kg(Time frame:16 weeks)
- Blood pressure in mm Hg(Time frame: 16 weeks)
- Grip force per kg mass(Time frame: 16 weeks)
- Fasting blood glucose concentration in blood(Time frame: 16 weeks)
- Concentration of FGF21 in blood(Time frame: 16 weeks)
- HOMA-IR index using insulin and glucose concentration in blood(Time frame: 16 weeks)
- Concentration of ApoB in blood(Time frame: 16 weeks)
- Concentration of Lipid panel in blood(Time frame: 16 weeks)
- Concentration of IGF-1 in blood(Time frame: 16 weeks)
- Concentration of Complex lipids panel in blood(Time frame: 16 weeks)
- Concentration of C-peptide(Time frame: 16 weeks)
- Concentration of HsCRP in blood(Time frame: 16 weeks)
- Height in cm(Time frame: 16 weeks)
- heart rate in beats per minute(Time frame: 16 weeks)
研究者
Moul Dey
Professor
South Dakota State University