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OpenTrials
Completed

NCT Number: NCT01665482

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

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

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Malaysia Palm Oil Board (MPOB)

Kajang, Selangor, 43000, Malaysia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

A 2000 kcal test meal

Other

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

Other

Primary outcomes

  1. Interleukin-6

    Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.

  2. C-peptide

    Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.

Secondary outcomes

  1. hsCRP

    Time frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18.

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Collaborators

  • University of Malaya

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 15, 2012
Registry last updated
Aug 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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