Randomised Trial of Different Dietary Fat Sources on Blood Lipids and Other CVD Risk Factors in Health Men and Women
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- LDL-Cholesterol
研究概览
简要总结
This is a randomised trial in which healthy volunteers, men and women aged 50-75 years from the general community are randomized into one of three arms: participants will be provided with 50 gm extra virgin coconut oil, or 50 grams butter or 50 extra virgin olive oil to be eaten daily for a month. The food will be provided in the form of processed cheese to mask participants. The key outcome is blood low density lipoprotein cholesterol concentrations and secondary outcomes blood lipid profile (total cholesterol, high density lipoprotein cholesterol, triglycerides) and anthropometric measures: weight and waist circumference. This trial is powered to detect a difference of 0.5 mmol/L LDL-cholesterol difference between the trial arms.
详细描述
This is a randomized trial in which healthy volunteers from the general community are randomized into one of three arms: consumption of 50 gm of extra virgin coconut oil daily OR 50gm of butter daily OR 50gm of extra virgin olive oil daily (50gm is about 2 ounces, or 2 table spoons), to be consumed over a one month period. The food will be provided in the form of processed cheese to mask participants.
After full informed consent, participants will attend an assessment visit and have a baseline measures of weight, height, waist circumference, blood pressure, a blood sample for assessment of blood lipids and other metabolic markers, and fill in a health questionnaire and dietary questionnaire. Participants will be randomly allocated to one of three arms: coconut oil, butter or olive oil and will be given supplies of these
After one month, participants will return for follow up assessment which will include a repeat blood sample, anthropometric measures and blood pressure, and questionnaire.
Blood samples collected by venipuncture will be stored at the University of Reading.
At the end of the study, all participants will be given the individual participant results of the anthropometric measures and lipid profiles at baseline and follow up as well as the overall findings of the trial.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Fats will be embedded in processed cheese - extend of masking will be assessed in sensory study
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to participate in the trial of dietary interventions for one month within the age range
排除标准
- •No known cardiovascular disease: heart disease or stroke; no known cancer; no known diabetes; no use of lipid lowering medication eg. statins; no contraindications to high fat diet e.g. gall bladder or other gastrointestinal condition
研究组 & 干预措施
Butter
50g Butter to be consumed daily for four weeks
干预措施: Butter (Other)
Olive oil
50g extra virgin olive oil to be consumed daily for four weeks
干预措施: Olive oil (Other)
Coconut oil
50g extra virgin coconut oil to be consumed daily for four weeks
干预措施: Coconut oil (Other)
结局指标
主要结局
LDL-Cholesterol
时间窗: 4 weeks
Blood LDL cholesterol concentrations
次要结局
- HDL cholesterol(4 weeks)
- Total Cholesterol(4 weeks)
- Triglycerides(4 weeks)
研究者
Gunter G C Kuhnle
Associate Professor in Nutrition and Health
University of Reading