Lipid Metabolism Disorder Clinical Trial
Official title:
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
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.
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.
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