Improvement of Nutritional Status and Blood Lipid Profile by Using MCT Oil on Overweight and Obese Women
Condition: Obesity Adult Onset; Lipid Metabolism Disorder
MeSH terms: Overweight; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Soya bean oil; MCT oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume soya bean oil together with yogurt in lunch daily meals and be monitored side effects and diarrhea. Then they will be evaluated anthropometric index, body compositions and blood lipid profile after 2 months (T1) and 4 months (T2) intervention. This product is composed of 12% total energy intake of participants.; Participants will consume MCT oil together with yogurt in lunch daily meals and be monitored side effects and diarrhea. Then they will be evaluated anthropometric index, body compositions and blood lipid profile after 2 months (T1) and 4 months (T2) intervention. This product is composed of 12% total energy intake of participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized, double-blind, community-controlled intervention trial. A screening survey will be used to recruit women aged from 20 to 45 considered overweight and obese within a city of Bac Giang province, Viet Nam, during which subjects will conduct nutritional status and determine whether overweight or obesity and eligible criteria. Subjects then will be randomly allocated to receive 1 of 2 treatment sequences, with a balanced number of subjects assigned to each dietary treatment (either MCT oil or Soya bean oil/soy oil mixed in yogurt together with their standard meals (lunch) daily) over a period of 4 months and their blood lipid and nutritional profiles checked.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obesity; medium chain triglycerides; blood lipid profile