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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-08

Study Completion Date

2020-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity Adult Onset Lipid Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

The list of participants will be randomly coded and divided two group will be sealed. This envelop will stored by the head of National Institute of Nutrition, Vietnam. The investigators will be not known who the participants consume test product or placebo product during the recruiting stage and whole intervention period. The oil product will be packed in the same bottles (only different from coloring the label bottles), manufactured by Nortalic, Vietnam.

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Soya bean oil

Intervention Type DIETARY_SUPPLEMENT

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 consumption

20g MCT oil (containing 100% MCT) together with 100g yogurt) will be provided in lunch-daily meal for a period of 4 months.

Group Type EXPERIMENTAL

MCT oil

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No