Text Size

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

This study has been completed.
Sponsor:
Collaborator:
University of Malaya
Information provided by (Responsible Party):
Malaysia Palm Oil Board
ClinicalTrials.gov Identifier:
NCT01665482
First received: August 12, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention
Inflammation
Insulin Sensitivity
 Other: A 2000 kcal test meal
Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effects of Dietary Fats on Cardiovascular Health and Insulin Sensitivity in Subjects With Abdominal Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Malaysia Palm Oil Board:

Primary Outcome Measures:
  • Interleukin-6 [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]
  • C-peptide [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hsCRP [ Time Frame: Baseline, week-5, week-6, week-11, week-12, week-17 and week-18. ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saturated fat rich diet Other: A 2000 kcal test meal
Active Comparator: Monounsaturated fat rich diet Other: A 2000 kcal test meal
Active Comparator: Carbohydrate/ Low fat diet Other: A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665482

Locations
Malaysia
Malaysia Palm Oil Board (MPOB)
Kajang, Selangor, Malaysia, 43000
Sponsors and Collaborators
Malaysia Palm Oil Board
University of Malaya
Investigators
Principal Investigator: Teng Kim Tiu, PhD MPOB
  More Information

No publications provided

Responsible Party: Malaysia Palm Oil Board
ClinicalTrials.gov Identifier: NCT01665482     History of Changes
Other Study ID Numbers: PD155/11
Study First Received: August 12, 2012
Last Updated: August 14, 2012
Health Authority: Malaysia: Institutional Review Board

Keywords provided by Malaysia Palm Oil Board:
Inflammation
Insulin sensitivity
Interleukin-6 (IL-6)
C-peptide
 Saturated fatty acid (SFA)
Monounsaturated fatty acid (MUFA)
Carbohydrate (CARB)

Additional relevant MeSH terms:
Inflammation
Obesity
Obesity, Abdominal
Insulin Resistance
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013