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

September 8, 2020 updated by: Tu Nguyen Song, National Institute of Nutrition, Vietnam

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
161

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Hanoi, Vietnam, 70000
        • National Institute of Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: LCT consumption
20g soy oil (containing mainly long chain triglycerides - LCT) together with 100g yogurt) will be provided in lunch-daily meal for a period of 4 months.
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.
Experimental: MCT consumption
20g MCT oil (containing 100% MCT) together with 100g yogurt) will be provided in lunch-daily meal for a period of 4 months.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood lipid profile, i.e. changes of blood lipid measurements
Time Frame: over 2 and 4 months intervention
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index, i.e. changes of Body Mass Index (BMI)
Time Frame: over 2 and 4 months
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
Waist - Hip Ratio, i.e. changes of Waist - Hip Ratio (WHR)
Time Frame: over 2 and 4 months
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
Percentage of total fat, i.e. changes of percentage of total fat
Time Frame: over 2 and 4 months
Measurement of total fat percentage is measured by the Body composition analyzer SC-330 TANITA scale.
over 2 and 4 months
Fat mass, i.e. changes of fat mass
Time Frame: over 2 and 4 months
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fasting blood glucose, i.e. changes of fasting blood glucose
Time Frame: at baseline time, over 2 and 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Institute of Nutrition, Vietnam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tu S Nguyen, PhD., National Institute of Nutrition, Vietnam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Nortalic-NIN 176

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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