Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
Primary Purpose
Inflammation, Insulin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
A 2000 kcal test meal
A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
Sponsored by
About this trial
This is an interventional prevention trial for Inflammation focused on measuring Inflammation, Insulin sensitivity, Interleukin-6 (IL-6), C-peptide, Saturated fatty acid (SFA), Monounsaturated fatty acid (MUFA), Carbohydrate (CARB)
Eligibility Criteria
Inclusion Criteria:
- Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female),
- Age 20-60 years
Exclusion Criteria:
- a medical history of cardiovascular disease, diabetes, dyslipidemia;
- current use of antihypertensive or lipid lowering medication;
- plasma cholesterol > 6.5 mmol/L, TAG > 4.5 mmol/L;
- alcohol intake exceeding a moderate intake (> 28 units per week);
- pregnancy,
- smoker and
- breastfeeding.
Sites / Locations
- Malaysia Palm Oil Board (MPOB)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Saturated fat rich diet
Monounsaturated fat rich diet
Carbohydrate/ Low fat diet
Arm Description
Outcomes
Primary Outcome Measures
Interleukin-6
C-peptide
Secondary Outcome Measures
hsCRP
Full Information
NCT ID
NCT01665482
First Posted
August 12, 2012
Last Updated
August 14, 2012
Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
1. Study Identification
Unique Protocol Identification Number
NCT01665482
Brief Title
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
Official Title
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaysia Palm Oil Board
Collaborators
University of Malaya
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rationale: It is well established that increased intake of saturated fatty acids (SFA) is associated with incidence of cardiovascular heart disease (CHD). This effect is mediated by dietary saturated fat's impact on fasting plasma cholesterol levels. Research is needed to clarify the association between dietary fatty acids and metabolic risk markers beyond lipid profile. World Health Organisation (WHO) has recommended reduced intake of SFA with energy replacement from monounsaturated fatty acids (MUFA) or carbohydrates (CARB). However, limited evidence is available on the effects of dietary fatty acids on insulin sensitivity and secretion. The current study is designed to investigate the effects of SFA versus MUFA versus CARB on insulinemic response and lipid metabolism in healthy individuals with central obesity.
Study design: A randomized, crossover, single blind design study was carried out. The subjects consumed controlled diets for 6 weeks each. They were provided 3 meals per day during weekdays in which SFA, MUFA and CARB diet was assigned to them randomly. Protein content was standardised at 14% energy. The SFA and MUFA diets each provided 31.5% energy intake from fat, with 69% of the total fats replaced by test fats (approximately 49 g/d based on a 2000 kcal basic diet). Each individual fatty acid provided approximately 7% of the total energy intake. The CARB diet provided approximately 34 g/day experimental fat based on a 2000 kcal basic diet. The CARB diet replaced 7 % energy of carbohydrate from total fat with the exchange from oleic acid (C18:1).
Hypothesis: Changing energy from dietary fat (SFA and MUFA) to carbohydrate will influence insulin sensitivity, endothelial and vascular function, pro-inflammatory markers and lipid metabolism differently in individuals with metabolic syndrome. SFA (palm olein) may be comparable with MUFA (high oleic sunflower oil) with regards to its effects on insulin sensitivity, endothelial and vascular function and inflammation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Insulin Sensitivity
Keywords
Inflammation, Insulin sensitivity, Interleukin-6 (IL-6), C-peptide, Saturated fatty acid (SFA), Monounsaturated fatty acid (MUFA), Carbohydrate (CARB)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saturated fat rich diet
Arm Type
Active Comparator
Arm Title
Monounsaturated fat rich diet
Arm Type
Active Comparator
Arm Title
Carbohydrate/ Low fat diet
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
A 2000 kcal test meal
Intervention Type
Other
Intervention Name(s)
A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate
Primary Outcome Measure Information:
Title
Interleukin-6
Time Frame
Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
Title
C-peptide
Time Frame
Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
Secondary Outcome Measure Information:
Title
hsCRP
Time Frame
Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Abdominally obese males and females (waist circumference > 90 cm for male, > 80 cm for female),
Age 20-60 years
Exclusion Criteria:
a medical history of cardiovascular disease, diabetes, dyslipidemia;
current use of antihypertensive or lipid lowering medication;
plasma cholesterol > 6.5 mmol/L, TAG > 4.5 mmol/L;
alcohol intake exceeding a moderate intake (> 28 units per week);
pregnancy,
smoker and
breastfeeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teng Kim Tiu, PhD
Organizational Affiliation
MPOB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malaysia Palm Oil Board (MPOB)
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
12. IPD Sharing Statement
Citations:
PubMed Identifier
27919361
Citation
Chang LF, Vethakkan SR, Nesaretnam K, Sanders TA, Teng KT. Adverse effects on insulin secretion of replacing saturated fat with refined carbohydrate but not with monounsaturated fat: A randomized controlled trial in centrally obese subjects. J Clin Lipidol. 2016 Nov-Dec;10(6):1431-1441.e1. doi: 10.1016/j.jacl.2016.09.006. Epub 2016 Sep 17.
Results Reference
derived
PubMed Identifier
27642057
Citation
Teng KT, Chang LF, Vethakkan SR, Nesaretnam K, Sanders TAB. Effects of exchanging carbohydrate or monounsaturated fat with saturated fat on inflammatory and thrombogenic responses in subjects with abdominal obesity: A randomized controlled trial. Clin Nutr. 2017 Oct;36(5):1250-1258. doi: 10.1016/j.clnu.2016.08.026. Epub 2016 Sep 8.
Results Reference
derived
Learn more about this trial
Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity
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