Study on the Efficacy of MCT (Medium-chain Triglycerides) Oil Consumption on Nutritional Status and Blood Lipid Profile in Overweight and Obese (Class II) Vietnamese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 2
- 主要终点
- Blood lipid profile, i.e. changes of blood lipid measurements
研究概览
简要总结
The purpose of this study is to examine whether MCT oil is effective in the change of blood lipid profile and body compositions on overweight or obese women aged 20-45.
详细描述
A randomized, double-blinded, community-controlled trial will be conducted to verify the effects of MCT oil on blood lipid profile and body compositions. 160 overweight or obese female subjects aged 20-45 years with body weight index [25 kg/m2 ≤ body mass index (BMI) < 40 kg/m2] will be recruited. The subjects will visit the research site for 4 times. On the first visit, the participants will be recruited to determine exact BMI, age range and eligible criteria. On the second visit, the recruited participants will be randomly assigned to consume a test or placebo product [test product: plain yogurt blending MCT oil; placebo product: plain yogurt blending soy oil (mainly long chain triglycerides - LCT)] and ingest the assigned product in daily lunch meals for 4 months. On the next 3 visits (at baseline, 2 months and 4 months after intervention), the 12-hr fasting blood samples test will be conducted to check lipid blood profile and glucose; the body compositions and anthropometric index will be measured.
Plans for site monitoring will be conducted by the independent supervisors from the National Institute of Nutrition's Experts who come from the different departments of NINVietnam and the experts of the collaborator for each visiting day and on the days when the participants receive products (every 10 days). In the site research, multiply supervised and cross-over staff will be implemented (staff from NINVietnam, Center of Disease Control branch, Medical Center of Province and Local Ward Health Stations). For following the consumed products, each participant will daily self-note in a designed notebook (trained before delivering products). If there is any different information between the staff and others, information will be checked again. The participants, consuming at least 90% the total amount of product, will be considered as complete intervention and will be analyzed.
Data will be collected by questionnaire and checked again in the same day of collecting. Investigators will request and correct at the site research if any suspicious answer or missing data. The Body composition analyzer SC-330 TANITA scale will be checked and corrected before using. Each 100 subjects, this scale will be checked and corrected again. Data are reported as mean ± standard deviation, compared between 2 arms and in each group between baseline time and 2 or 4 months interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The list of participants will be randomly coded and divided two group will be sealed. This envelop will stored by the head of National Institute of Nutrition, Vietnam. The investigators will be not known who the participants consume test product or placebo product during the recruiting stage and whole intervention period. The oil product will be packed in the same bottles (only different from coloring the label bottles), manufactured by Nortalic, Vietnam.
入排标准
- 年龄范围
- 20 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •In Recruiting investigation:
- •Citizen women from 20 to 45 years old in the selected area
- •Subjects at risk of being overweight, obese or having BMI > 23 (self-estimate)
- •Voluntarily agree to participate
- •In Intervention study:
- •Eligible criteria from screening investigation
- •Body Mass Index from 25.0 to 39.99 kg/m2
- •Voluntarily agree to participate
排除标准
- •In Recruiting investigation:
- •History/presence of high blood pressure or diabetes
- •Pregnant or breastfeeding women
- •In Intervention study:
- •Medication known to affect body weight
- •Chronic diseases
- •Plan to move out of the area within next 6 months
- •Plan to have pregnancy within next 4-5 months
结局指标
主要结局
Blood lipid profile, i.e. changes of blood lipid measurements
时间窗: over 2 and 4 months intervention
Blood samples are drawn after 12 hours and not over 16 hours overnight fasting and at least 24 hours of alcohol abstinence and collected in Heparin-containing (BD Vacutainer USA) tubes. Blood samples will consist of Cholesterol, Triglyceride, HDL-cholesterol and LDL-cholesterol and evaluated by The National Cholesterol Education Program (NCEP), e.g. JAMA, 2001. 285(19): p. 2486-2497
次要结局
- Body Mass Index, i.e. changes of Body Mass Index (BMI)(over 2 and 4 months)
- Percentage of total fat, i.e. changes of percentage of total fat(over 2 and 4 months)
- Fat mass, i.e. changes of fat mass(over 2 and 4 months)
- Waist - Hip Ratio, i.e. changes of Waist - Hip Ratio (WHR)(over 2 and 4 months)
研究者
Tu Nguyen Song
Head of Division Planning
National Institute of Nutrition, Vietnam
