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

NCT01665482 | Completed DMC

• 1 other identifier: PD155/11
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Conditions

Inflammation; Insulin Sensitivity

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Interleukin-6

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

• C-peptide

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

Secondary Outcomes (1)

• hsCRP

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

Study Arms (3)

Saturated fat rich diet

ACTIVE COMPARATOR

Other: A 2000 kcal test meal

Monounsaturated fat rich diet

ACTIVE COMPARATOR

Other: A 2000 kcal test meal

Carbohydrate/ Low fat diet

ACTIVE COMPARATOR

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

Interventions

A 2000 kcal test meal OTHER

Monounsaturated fat rich diet; Saturated fat rich diet

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

Carbohydrate/ Low fat diet

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Abdominally obese males and females (waist circumference \> 90 cm for male, \> 80 cm for female),
• Age 20-60 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Malaysia Palm Oil Board: lead
• University of Malaya: collaborator

Study Sites (1)

Malaysia Palm Oil Board (MPOB)

Kajang, Selangor, 43000, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 27919361 DERIVED

• 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.

  PMID: 27642057 DERIVED

MeSH Terms

Conditions

Inflammation; Insulin Resistance

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Teng Kim Tiu, PhD

  MPOB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 15, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 15, 2012

Record last verified: 2012-08

Locations

MY (1)