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

Metabolic Syndrome Clinical Trial

Official title:

Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571947
• Other study ID #: A003.11
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: July 22, 2014
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Malaysia	Malaysia Palm oil Board	Kajang	Selangor
Malaysia	Malaysian Palm Oil Board (MPOB)	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide		6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)	No
Secondary	Insulin		6 hours	No