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

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01571947
First received: April 3, 2012
Last updated: July 22, 2014
Last verified: July 2014

April 3, 2012
July 22, 2014
November 2011
June 2012   (final data collection date for primary outcome measure)
C-peptide [ Time Frame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min) ] [ Designated as safety issue: No ]
C-peptide [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01571947 on ClinicalTrials.gov Archive Site
Insulin [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Insulin [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome
Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Metabolic Syndrome
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.
  • Active Comparator: SFA
    Intervention: Other: Acute Effects of Fats and Carbohydrate
  • Active Comparator: MUFA
    Intervention: Other: Acute Effects of Fats and Carbohydrate
  • Active Comparator: PUFA
    Intervention: Other: Acute Effects of Fats and Carbohydrate
  • Active Comparator: CARB
    Intervention: Other: Acute Effects of Fats and Carbohydrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2014
June 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT01571947
A003.11
Yes
Malaysia Palm Oil Board
Malaysia Palm Oil Board
University of Malaya
Principal Investigator: Kim-Tiu Teng, PhD Malaysian Palm Oil Board
Malaysia Palm Oil Board
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP