Clinical trial NCT04067323: Improvement of Nutritional Status and Blood Lipid Profile by Using MCT Oil on Overweight and Obese Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity Adult Onset
Lipid Metabolism Disorder
Keywords: obesity
medium chain triglycerides
blood lipid profile
Lead sponsor: National Institute of Nutrition, Vietnam
Sponsor class: OTHER_GOV
First posted: 2019-08-26
Enrollment: 161
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood lipid profile, i.e. changes of blood lipid measurements
timeFrame: over 2 and 4 months intervention
Secondary outcomes:
measure: Body Mass Index, i.e. changes of Body Mass Index (BMI)
timeFrame: over 2 and 4 months
measure: Waist - Hip Ratio, i.e. changes of Waist - Hip Ratio (WHR)
timeFrame: over 2 and 4 months
measure: Percentage of total fat, i.e. changes of percentage of total fat
timeFrame: over 2 and 4 months
measure: Fat mass, i.e. changes of fat mass
timeFrame: over 2 and 4 months
Other outcomes:
measure: Fasting blood glucose, i.e. changes of fasting blood glucose
timeFrame: at baseline time, over 2 and 4 months
Locations:
city: Hanoi
country: Vietnam
facility: National Institute of Nutrition
Study officials:
affiliation: National Institute of Nutrition, Vietnam
name: Tu S Nguyen, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/07315724.2008.10719737.