Investigating the Effects of Milk Protein Versus Soy Protein on Essential Omega-3 Fatty Acid Metabolism: A Randomized Parallel-arm Human Trial in Healthy Canadian Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Change in plasma EPA and DHA content from baseline
研究概览
简要总结
Dairy products provide macronutrients, vitamins, and minerals that are important for health and development. Despite this, many Canadians now eat fewer dairy products and are instead consuming more non-dairy alternatives, such as soy. Some of this is because of misconceptions about the effects of dairy on health. However, the study investigators hypothesize that, compared to soy, dairy may actually improve a person's health due to its effects on the enzymes in the body that make omega-3 fatty acids, such as EPA and DHA. The goal of this study is to examine omega-3 metabolism in men and women consuming either milk or soy protein. Briefly, this study will determine if the consumption of milk or soy protein differentially impacts blood EPA and DHA levels, the synthesis of EPA and DHA, fatty acid oxidation, and omega-3 fat absorption from the gut. It is anticipated that the findings from this novel and innovative research project will provide high quality evidence to support a previously unappreciated protective effect of dairy for human health and development.
详细描述
Direct comparisons between dairy and non-dairy plant-based alternatives on metabolic processes in humans are limiting. The study investigators recently completed a cross-sectional analysis in over 1000 young Canadian adult men and women and reported that the consumption of soy beverages/foods was associated with a reduction in estimated fatty acid desaturase pathway activity compared to milk and dairy food consumption (PMID: 34444977). The fatty acid desaturase pathway controls the endogenous synthesis of beneficial long-chain omega-3 polyunsaturated fatty acids (n3-LCPUFA), such as eicosapentaenoic and docosahexaenoic acids (EPA and DHA), from the essential fatty acid, alpha-linolenic acid (ALA). Epidemiological and clinical studies have reported that higher levels of EPA and DHA in the body are associated with reduced CVD risk. Thus, this prior work identified a previously unrecognized cardio-protective role for dairy that could help to counter consumer misconceptions about dairy increasing cardiovascular disease (CVD) risk.
The primary outcome of this research proposal is to determine if the consumption of dairy protein supports n3-LCPUFA synthesis compared to soy protein. The investigators hypothesize that study participants consuming dairy protein will show a greater conversion of ALA into EPA and DHA via the fatty acid desaturase pathway compared to study participants consuming soy protein. To test this hypothesis, the investigators will conduct a randomized, parallel-arm clinical trial in healthy adult men and women who are consuming either a diet containing milk protein isolate (and no soy) or a diet containing soy protein isolate (and no dairy).
Additional secondary outcomes of interest to further advance understanding of how milk and soy proteins affect acute and chronic ALA metabolism will include:
- Whole blood gene expression analysis of fatty acid desaturases and elongases to determine if milk and soy proteins influence n3-LCPUFA synthesis through a transcriptional mechanism.
- Breath sample analysis to determine if milk and soy proteins influence ALA degradation through β-oxidation.
- An oral fat tolerance test (OFTT) to examine if milk and soy proteins modify ALA absorption from the gut.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men and pre-menopausal women
- •Must be able to consume soy and dairy beverages and foods
- •Sufficient level of education to understand study procedures and be able to communicate with clinical staff
排除标准
- •Body mass index greater than 35 kg/m2
- •Pregnant or lactating
- •Neuropsychiatric disorders (major depression, schizophrenia)
- •Digestive disorders
- •Inflammatory disease
- •Cardiovascular disease
- •Use of omega-3 supplements within the last 3 months
- •Regular consumption of oily fish
- •Allergies/sensitivities to dairy and/or soy food products
- •Use of lipid-lowering or digestive medication
结局指标
主要结局
Change in plasma EPA and DHA content from baseline
时间窗: Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31
The change in plasma EPA and DHA content from baseline will be determined by using gas chromatography at multiple time points during the 31-day dietary intervention in which study participants consume 2 smoothies per day containing either a milk protein isolate (MPI) or a soy protein isolate (SPI).
次要结局
- Change in EPA and DHA synthesis from baseline(Measured on days: 0 (baseline), 15, 17, 19, 22, 24, 26, 29, 30, and 31)
- Change in ALA absorption from balance(Measured on days: 0 (baseline) and 31)
- Change in whole blood gene expression from baseline(Measured on days: 0 (baseline) and 31)
- Change in fatty acid oxidation from baseline(Measured on days: 0 (baseline), 15, 30, and 31)
研究者
David M Mutch
Professor
University of Guelph