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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665482
• Other study ID #: PD155/11
• Status: Completed
• Phase: N/A
• First received: August 12, 2012
• Last updated: August 14, 2012
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: August 2012
• Source: Malaysia Palm Oil Board
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Insulin Resistance
• Insulin Sensitivity
• Obesity, Abdominal

Intervention

Other:
• A 2000 kcal test meal

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

Locations

Country	Name	City	State
Malaysia	Malaysia Palm Oil Board (MPOB)	Kajang	Selangor

Sponsors (2)

Lead Sponsor	Collaborator
Malaysia Palm Oil Board	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6		Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.	No
Primary	C-peptide		Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.	No
Secondary	hsCRP		Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.	No