Clinical trial NCT01571947: Acute Effects of Dietary Fats and Carbohydrate in Subjects With Metabolic Syndrome
Official title: Acute Effects of Dietary Fats and Carbohydrate on Insulinaemia, Lipaemia, Inflammatory Responses and Gastrointestinal Peptide Secretion in Subjects With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: Insulinaemia
inflammatory markers
gastrointestinal peptides
SFA
dietary fats
carbohydrate
insulin sensitivity
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2012-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: C-peptide
timeFrame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
Secondary outcomes:
measure: Insulin
timeFrame: 6 hours
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: Malaysia Palm oil Board
state: Selangor
city: Kajang
country: Malaysia
facility: Malaysian Palm Oil Board (MPOB)
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Kim-Tiu Teng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.