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Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01665482
Enrollment
47
Registered
2012-08-15
Start date
2012-03-31
Completion date
2012-07-31
Last updated
2012-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Insulin Sensitivity

Keywords

Inflammation, Insulin sensitivity, Interleukin-6 (IL-6), C-peptide, Saturated fatty acid (SFA), Monounsaturated fatty acid (MUFA), Carbohydrate (CARB)

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

Interventions

OTHERA 2000 kcal test meal
OTHERA 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate

Sponsors

University of Malaya
CollaboratorOTHER
Malaysia Palm Oil Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Abdominally obese males and females (waist circumference \> 90 cm for male, \> 80 cm for female), 2. 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.

Design outcomes

Primary

MeasureTime frame
Interleukin-6Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.
C-peptideBaseline, week-5, week-6, week-11, week-12, week-17 and week-18.

Secondary

MeasureTime frame
hsCRPBaseline, week-5, week-6, week-11, week-12, week-17 and week-18.

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026