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
Verified date | September 2020 |
Source | National Institute of Nutrition, Vietnam |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 161 |
Est. completion date | June 28, 2020 |
Est. primary completion date | March 31, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility |
Inclusion Criteria: 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 Exclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
Vietnam | National Institute of Nutrition | Hanoi |
Lead Sponsor | Collaborator |
---|---|
National Institute of Nutrition, Vietnam |
Vietnam,
St-Onge MP, Bosarge A, Goree LL, Darnell B. Medium chain triglyceride oil consumption as part of a weight loss diet does not lead to an adverse metabolic profile when compared to olive oil. J Am Coll Nutr. 2008 Oct;27(5):547-52. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fasting blood glucose, i.e. changes of fasting blood glucose | Blood samples were drawn after 12 hours and not over 16 hours overnight fasting and at least 24 hours of alcohol abstinence and collected in Heparin-containing tubes and analyzed at the same time with blood lipid profile. Fasting blood glucose will be measured by Beckman Coulter AU 680 automated analyzer and evaluated by American Diabetes Association: e.g. Diabetes Care, 2010: p. 33 (suppl): S11-S69. | at baseline time, over 2 and 4 months | |
Primary | Blood lipid profile, i.e. changes of blood lipid measurements | 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 | over 2 and 4 months intervention | |
Secondary | Body Mass Index, i.e. changes of Body Mass Index (BMI) | Weight is measured in kg with one decimal value by the Body composition analyzer SC-330 TANITA scale. Height is measured by wooden stadiometer with exactly 0.1cm. Then, these raw data will be calculated to BMI (kg/m^2). All data will be measured at the time T0 (at baseline), T1 (after 2 months) and T2 (after 4 months). | over 2 and 4 months | |
Secondary | Waist - Hip Ratio, i.e. changes of Waist - Hip Ratio (WHR) | Waist and hip circumferences are measured in cm, with one decimal value are by tape. Participants wear light clothes while measuring. | over 2 and 4 months | |
Secondary | Percentage of total fat, i.e. changes of percentage of total fat | Measurement of total fat percentage is measured by the Body composition analyzer SC-330 TANITA scale. | over 2 and 4 months | |
Secondary | Fat mass, i.e. changes of fat mass | Measurement of fat mass is measured in kg, with one decimal by the Body composition analyzer SC-330 TANITA scale. | over 2 and 4 months |
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