Effects of Triacylglycerol Structure on Gut Hormones and Haemostatic Markers

NCT01906359 | Completed

• 2 other identifiers: A005/11NMRR-12-146-11363
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 5

Brief Summary

Type 2 diabetes mellitus (T2DM) is a chronic disorder determined by lifestyle and genes. It is associated with chronic hyperglycaemia along with other metabolic abnormalities. It is also one of the risk factors for cardiovascular disease (CVD). This disease is due to insulin resistance and/or deficiency as well as increased hepatic glucose output. According to the Third National Health and Morbidity Survey (3rd NHMS), the prevalence of T2DM for adults aged 30 years and above is 14.9%, increased by almost 80% from 1996 to 2006. Dietary composition may affect insulin sensitivity, postprandial triacylglycerol concentration and the risk of T2DM. The role of dietary fats in T2DM is of particular interest and has been clinically studied for many decades. The type of fat we ingest every day consists of different types of fatty acids and different degree of saturation, which in turn influence glucose metabolism by altering cell membrane function, enzyme activity, insulin signalling and gene expression. Previous studies demonstrated that interesterification of dietary fat alter postprandial lipaemia. Saturated fat such as palm olein has been reported to display lower postprandial lipaemia after interesterification. Changing the structure of triacylglycerol (TAG) alters the physical properties of dietary fat which affects digestibility, metabolism and atherogenicity. A recent study conducted by Sanders and co-workers demonstrated reduced levels of plasma glucose-dependent insulinotropic polypeptide (GIP) following both the lard and interesterified palm olein (IPO) compared with the palm olein (PO) and high oleic sunflower oil (HOS) diets in healthy subjects. The GIP and glucagon-like peptide-1 (GLP-1) are major players in the modulation of postprandial insulin secretion by the pancreas. Although GIP secretion in response to meals is normal in patients with Type 2 diabetes mellitus (T2DM), GIP induced secretion of insulin is defective in diabetes. This is observed to be predominantly a defective stimulation of the late phase of insulin response (20-120 minutes). The effect of IPO on GIP may be exaggerated in T2DM patients with impaired insulin sensitivity. Hence, IPO may change the concentrations of gut hormones, postprandial lipaemia, insulinaemic response and CVD related haemostatic markers.

Conditions

Type 2 Diabetes Mellitus

Keywords

Interesterified fat; Stereospecific number 2; Gut hormones; GIP; Insulin sensitivity; Postprandial lipaemia; Haemostatic markers

Outcome Measures

Primary Outcomes (1)

• 6-hour postprandial changes from fasting in glucose-dependent insulinotropic polypeptide (GIP)

  To determine the postprandial changes of GIP.

  0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

Secondary Outcomes (5)

• 6-hour postprandial changes from fasting in gut hormones

  0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 h

• 6-hour postprandial changes from fasting in insulinaemic response

  0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

• 6-hour postprandial changes from fasting in lipaemia

  0, 1, 2, 3, 4, 5, 6 hour for TAG and apoB48; 6 hour postheparin for LPL; pooled 3, 4, 5 hour for chylomicron and PFA

• 6-hour postprandial changes from fasting in haemostatic response

  0, 2, 4, 6 hour for FVIIa, PAI-1 and D-dimer; 0, 4 hour for PWA

• 6-hour changes from fasting hunger rating using visual analogue scale (VAS)

  0, 15, 30, 60, 90, 120 min, 3, 4, 5, 6 hour

Study Arms (3)

Dietary fat - PO

EXPERIMENTAL

Native palm olein (IV56)

Other: Native palm olein (IV56)

Dietary fat - IPO

EXPERIMENTAL

Chemically interesterified palm olein (IV56)

Other: Chemically interesterified palm olein (IV56)

Dietary fat - HOS

EXPERIMENTAL

High oleic sunflower oil

Other: High oleic sunflower oil

Interventions

Native palm olein (IV56) OTHER

Test meal consists of a high fat muffin (containing 50 g native palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

Also known as: PO

Dietary fat - PO

Chemically interesterified palm olein (IV56) OTHER

Test meal consists of a high fat muffin (containing 50 g chemically interesterified palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

Also known as: IPO

Dietary fat - IPO

High oleic sunflower oil OTHER

Test meal consists of a high fat muffin (containing 50 g high oleic sunflower oil) and a cup of milkshake, to be taken as breakfast for each postprandial study day.

Also known as: HOS

Dietary fat - HOS

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild T2DM individuals not planned for medical intervention
• mmol/L ≤ fasting glucose ≤ 11.1 mmol/L
• % ≤ HbA1c ≤ 9.0%
• Not using antihypertensive, lipid lowering, insulin/glucose modulating medication
• Mild T2DM individuals currently on medical intervention
• Fasting glucose ≤ 11.1 mmol/L
• HbA1c ≤ 9.0%
• Using antihypertensive, lipid lowering or glucose modulating medication
• Malaysian male or female with T2DM aged between 30 to 60 years old
• Not using insulin
• Not having any complications of diabetes
• No medical history of myocardial infarction, angina, thrombosis, stroke or cancer
• Haemoglobin levels for females ≥ 11.5 gm/dl and males ≥ 12.5 gm/dl
• Serum ferritin \> 15 µg/l at commencement of study

You may not qualify if:

• Medical history of myocardial infarction, angina, thrombosis, stroke or cancer
• Underweight (BMI \< 18.5 kg/m²)
• Using insulin
• Total cholesterol \> 7.0 mmol/L
• Abnormal liver function, renal function and haematology
• Hypersensitive towards heparin
• Gastric or lactose intolerance
• Smoker
• Pregnancy and lactating
• Taking alcohol
• Taking alcohol
• Haemoglobin levels for females ≤ 11.5 gm/dl and males ≤ 12.5 gm/dl
• Serum ferritin \< 15 µg/l at commencement of study

Sponsors & Collaborators

• Malaysia Palm Oil Board: lead
• Universiti Putra Malaysia: collaborator
• Ministry of Health, Malaysia: collaborator

Study Sites (5)

Malaysian Palm Oil Board (MPOB)

Kajang, Selangor, 43000, Malaysia

Location

Hulu Langat District Health Office

Kajang, Selangor, 43100, Malaysia

Location

Sepang District Health Office

Sepang, Selangor, 43900, Malaysia

Location

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

Location

Selangor State Health Office

Shah Alam, Selangor, 40100, Malaysia

Location

Related Publications (1)

• Mo SY, Lai OM, Chew BH, Ismail R, Bakar SA, Jabbar NA, Teng KT. Interesterified palm olein lowers postprandial glucose-dependent insulinotropic polypeptide response in type 2 diabetes. Eur J Nutr. 2019 Aug;58(5):1873-1885. doi: 10.1007/s00394-018-1738-6. Epub 2018 Jun 5.

  PMID: 29872922 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Study Officials

• Kim Tiu Teng, PhD

  Malaysian Palm Oil Board (MPOB)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 24, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

MY (5)