- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01571947
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
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43000
- Malaysia Palm Oil Board
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Kajang, Selangor, Malaysia, 43000
- Malaysian Palm Oil Board (MPOB)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: SFA
|
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: MUFA
|
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: PUFA
|
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: CARB
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C-peptide
Time Frame: 6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
|
6 hours (0, 15, 30, 60, 90, 120, 180, 240, 300 and 360 min)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Insulin
Time Frame: 6 hours
|
6 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kim-Tiu Teng, PhD, Malaysia Palm Oil Board
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A003.11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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