Improvement of Nutritional Status and Blood Lipid Profile by Using MCT Oil on Overweight and Obese Women

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04067323
• Other study ID #: Nortalic-NIN 176
• Status: Completed
• Phase: N/A
• Start date: September 8, 2019
• Est. completion date: June 28, 2020

Study information

• Verified date: September 2020
• Source: National Institute of Nutrition, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Lipid Metabolism Disorder
• Lipid Metabolism Disorders
• Metabolic Diseases
• Obesity Adult Onset
• Overweight

Intervention

Dietary Supplement:
• Soya bean oil
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.
• MCT oil
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.

Locations

Country	Name	City	State
Vietnam	National Institute of Nutrition	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Nutrition, Vietnam

Country where clinical trial is conducted

Vietnam, 

References & Publications (1)

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

Outcome

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

External Links

•   Click here for more information about the organisation in which this study is conducted. The Division of Planning is responsible to plan and implement the project