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

NCT04067323 | Completed DMC

• 1 other identifier: Nortalic-NIN 176
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Adult Onset; Lipid Metabolism Disorder

Keywords

obesity; medium chain triglycerides; blood lipid profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Body Mass Index, i.e. changes of Body Mass Index (BMI)

  over 2 and 4 months

• Waist - Hip Ratio, i.e. changes of Waist - Hip Ratio (WHR)

  over 2 and 4 months

• Percentage of total fat, i.e. changes of percentage of total fat

  over 2 and 4 months

• Fat mass, i.e. changes of fat mass

  over 2 and 4 months

Other Outcomes (1)

• Fasting blood glucose, i.e. changes of fasting blood glucose

  at baseline time, over 2 and 4 months

Study Arms (2)

LCT consumption

PLACEBO COMPARATOR

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

MCT consumption

EXPERIMENTAL

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

Interventions

Soya bean oil 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.

LCT consumption

MCT oil 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.

MCT consumption

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Women, in Vietnam, who are in reproductive age usually following the intervention more than men and they are also more interested in their appearance. Investigators hope the participants will complete this study with at least withdrawal numbers.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Nutrition, Vietnam: lead

Study Sites (1)

National Institute of Nutrition

Hanoi, 70000, Vietnam

Location

Related 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. doi: 10.1080/07315724.2008.10719737.

  PMID: 18845704 RESULT

Related 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

MeSH Terms

Conditions

Lipid Metabolism Disorders; Obesity

Interventions

Soybean Oil

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Tu S Nguyen, PhD.

  National Institute of Nutrition, Vietnam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Division Planning

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 26, 2019
• Study Start: September 8, 2019
• Primary Completion: March 31, 2020
• Study Completion: June 28, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)