NCT01571947

Brief Summary

There is increasing evidence suggests that elevated levels of postprandial triacylglycerol (TAG)-rich lipoproteins may promote the development of cardiovascular diseases (CVD). A prolonged and elevated postprandial lipemia is associated with increased risk of CVD by a variety of mechanisms such as insulin resistance, inflammation, endothelial dysfunction and oxidative stress. However, current evidence on the acute effects of type of fats on postprandial insulinaemia, gastrointestinal peptide secretion, inflammatory response, as well as satiation are limited and inconsistent, in particular in metabolic syndrome population in Asian. Hence, this study aimed to investigate the postprandial effects of high fat meals enriched with i) palm olein, ii) high oleic sunflower oil, and iii) high linoleic sunflower oil, compared with a low fat/high carbohydrate meal, in 30 subjects with metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 23, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

April 3, 2012

Last Update Submit

July 22, 2014

Conditions

Metabolic Syndrome

Keywords

Insulinaemiainflammatory markersgastrointestinal peptidesSFAdietary fatscarbohydrateinsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • C-peptide

    6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)

Secondary Outcomes (1)

  • Insulin

    6 hours

Study Arms (4)

SFA

ACTIVE COMPARATOR
Other: Acute Effects of Fats and Carbohydrate

MUFA

ACTIVE COMPARATOR
Other: Acute Effects of Fats and Carbohydrate

PUFA

ACTIVE COMPARATOR
Other: Acute Effects of Fats and Carbohydrate

CARB

ACTIVE COMPARATOR
Other: Acute Effects of Fats and Carbohydrate

Interventions

Acute Effects of Fats and CarbohydrateOTHER

Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.

CARBMUFAPUFASFA

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20 - 60
  • Elevated TAG with at least 1.7 mmol/L
  • Low HDL cholesterol (\< 1.04 mmol/L for men, 1.3 mmol/L for women)
  • Elevated blood pressure (systolic at least 130, diastolic at least 85 mmHg)
  • Increased waist circumference (at least 90cm for men, 80cm for women)
  • Fasting plasma glucose between 5.6 and 7.0 mmol/L

You may not qualify if:

  • Underweight
  • Current use of antihypertensive or lipid lowering medication
  • Alcohol intake exceeding a moderate intake (\> 28 units per week)
  • Medical history of myocardial infarction, angina, thrombosis, stroke, cancer or diabetes
  • Pregnancy or breast-feeding
  • Smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Malaysia Palm oil Board

Kajang, Selangor, 43000, Malaysia

Location

Malaysian Palm Oil Board (MPOB)

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (2)

  • Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K, Teng KT. The amount and types of fatty acids acutely affect insulin, glycemic and gastrointestinal peptide responses but not satiety in metabolic syndrome subjects. Eur J Nutr. 2018 Feb;57(1):179-190. doi: 10.1007/s00394-016-1307-9. Epub 2016 Sep 8.

    PMID: 27632019DERIVED

  • Teng KT, Chang CY, Kanthimathi MS, Tan AT, Nesaretnam K. Effects of amount and type of dietary fats on postprandial lipemia and thrombogenic markers in individuals with metabolic syndrome. Atherosclerosis. 2015 Sep;242(1):281-7. doi: 10.1016/j.atherosclerosis.2015.07.003. Epub 2015 Jul 7.

    PMID: 26232169DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInsulin Resistance

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kim-Tiu Teng, PhD

    Malaysia Palm Oil Board

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

April 5, 2012

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2014

Last Updated

July 23, 2014

Record last verified: 2014-07

Locations

MY(2)