Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome

NCT ID: NCT01571947

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-07-31

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.

Detailed Description

A randomized, double-blind, crossover design study was conducted to test the acute effects of high fat meals enriched with (1) saturated fatty acids (SFA); (2) monounsaturated fatty acids (MUFA); (3) polyunsaturated fatty acids (PUFA) vs. (4) a low fat/high carbohydrate (CARB) meal on postprandial insulinaemic, lipaemic and inflammatory responses, as well as gastrointestinal peptide secretion and satiation on 30 metabolic syndrome subjects (15 men and 15 women). Primary outcome of this study is postprandial changes of C-peptide. Other measured outcomes including insulin and glucose responses, lipids, cytokines and gastrointestinal peptides. Subjective appetite measurements were taken as exploratory outcomes using visual analogue scales.

Subjects were asked to participate in four postprandial challenges, separated by at least one week. On the day preceding the postprandial intervention, subjects were provided a low fat meal (< 10 g) to consume as their evening meal. They were required to fast over night after 10 pm and arrive at the research unit at 7:30 am - 9:00 am the following morning. Fasting blood samples were collected and subjects were instructed to consume the allocated test meal within 10 minutes. Further venous blood will be collected at regular intervals for up to 6 hours postprandially. During the 6 hours of the experimental study, the subjects were refrained from the consumption of any food or drink except plain water which they will be asked to consume at regular intervals (up to 750 mL over the 6 hours).

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

SFA

Group Type: ACTIVE_COMPARATOR

Acute Effects of Fats and Carbohydrate

Intervention Type: OTHER

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.

MUFA

Group Type: ACTIVE_COMPARATOR

Acute Effects of Fats and Carbohydrate

Intervention Type: OTHER

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.

PUFA

Group Type: ACTIVE_COMPARATOR

Acute Effects of Fats and Carbohydrate

Intervention Type: OTHER

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.

CARB

Group Type: ACTIVE_COMPARATOR

Acute Effects of Fats and Carbohydrate

Intervention Type: OTHER

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.

Interventions

Acute Effects of Fats and Carbohydrate

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaya

OTHER

Sponsor Role: collaborator

Malaysia Palm Oil Board

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kim-Tiu Teng, PhD

Role: PRINCIPAL_INVESTIGATOR

Malaysia Palm Oil Board

Locations

Malaysia Palm oil Board

Kajang, Selangor, Malaysia

Malaysian Palm Oil Board (MPOB)

Kajang, Selangor, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 27632019 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26232169 (View on PubMed)

Other Identifiers

A003.11

Identifier Type: -

Identifier Source: org_study_id