Dietary Oils to Sustain Energy (DOSE) Study: Understanding How Consumption of Dietary Oils in Foods Influences Blood Fatty Acids and Body Weight
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Changes in blood fatty acid composition
研究概览
简要总结
The research study is an intervention and feasibility crossover design pilot study designed to assess if consuming 3 study foods made with either soybean oil or palm oil per day for 4 weeks can alter whole blood, plasma and erythrocyte fatty acids and body weight in overweight/obese adults. Additionally, the study will assess the adherence to consuming 3 study foods per day for 4 weeks and to assess if participant remain unaware of (or masked to) which study food group (soybean oil vs palm oil) they are consuming.
详细描述
The objectives of the study include
- To determine changes in whole blood, plasma and erythrocyte linoleic acid after 4 weeks of consuming 3 foods products made soybean oil and determine changes in plasma and erythrocyte oleic acid and palmitic acid after 4 weeks of consuming 3 food products per day made with palm oil in overweight/obese adults
- To determine changes in body weight in overweight/obese adults during four weeks of consuming 3 food products per day made with soybean oil and during four weeks of consuming 3 food products per day made with palm oil
- To determine if there is evidence of unmasking of the two food product groups (soybean oil or palm oil) during the study in participants and in study coordinators
- To determine adherence of consuming 3 food products per day made with either soybean or palm oil for 4 weeks in overweight/obese adults
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 25-80 years old
- •Nonsmokers
- •BMI 25-55 kg/m2
排除标准
- •Current or previous diagnosis of heart, kidney, and some liver diseases
- •Current or previous diagnosis some circulatory diseases and some autoimmune diseases
- •Treatment of current cancer diagnosis or current cancer diagnosis
- •Current or previous diagnosis of diabetes
- •Gastrointestinal diseases or disorders (including pancreatic) that influence nutrient digestion and absorption or gastric bypass surgery
- •Alcohol or drug abuse
- •Inability to access veins for venipuncture
- •Hypothyroidism or Hyperthyroidism diagnosis
- •Food Allergy or intolerances
- •Any dietary restriction where consumption of the study foods or any ingredient would be contraindicated
- •Use of medications where consuming the study foods would be contraindicated
- •Use of supplements or medications for weight loss or following a weight loss program
- •Use of supplements high in linoleic acid in the past 4 weeks prior to enrolling
- •Pregnancy and lactation
研究组 & 干预措施
Soybean Oil
Consumption of study foods each day made with soybean oil
干预措施: Soybean Oil Foods (Other)
Palm Oil
Consumption of study foods each day made with palm oil
干预措施: Palm Oil Foods (Other)
结局指标
主要结局
Changes in blood fatty acid composition
时间窗: Week 0, Week 2, Week 4, Week 6, Week 8, Week 10
Determine changes in whole blood, plasma and erythrocyte linoleic acid in the soybean oil arm and determine the changes in whole blood, plasma and erythrocyte oleic acid and palmitic acid in the palm oil arm. Fatty acids for all sample types are reported as percent of total identified
次要结局
- Evidence of unmasking(Week 4 and Week 10)
- Changes in body weight(Week 0, Week 2, Week 4, Week 6, Week 8, Week 10)
- Adherence to study food consumption(Week 2, Week 4, Week 8, Week 10)
研究者
Martha Belury
Associate Professor
Ohio State University