The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety

Healthy Men Clinical Trial

— INTERFAT  

Official title:

The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02365987
• Other study ID #: BDM/14/15-26
• Status: Completed
• Phase: N/A
• First received: February 11, 2015
• Last updated: March 7, 2017
• Start date: February 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used in commercial spreads versus the corresponding un-interesterified blend.

Description:

Aim: The current study aims to investigate the acute effects of commercially relevant interesterified 'hardstock' versus the corresponding un-interesterified blend on postprandial lipaemia, glycaemia, insulinaemia and gut hormone responses. Due to the previously observed differences in gut hormones following interesterified palm oil and un-interesterified palm oil by our group, we will also explore acute effects of these fats on satiety and rates of gastric emptying.

Hypothesis: Interesterification of a palm kernel and palm stearin fat blend, to produce a fat with a higher proportion of palmitic acid in the middle position of the TAG (but the same fatty acid composition), will alter postprandial lipid and glucose metabolism. It is also hypothesised that differences in rates of absorption between the test fats will influence gut hormone responses and feelings of satiety.

Subjects: Participants will include 10 healthy male volunteers. In order to determine the 'typical' response to the test fats, subjects must not be affected by metabolic syndrome in any way (obesity, dyslipidemia, insulin resistance or hypertension), they must be non-smokers (since smoking influences postprandial lipaemia), and be aged between the ages of 18 and 45 years (since above this age metabolic changes may take place that may affect the way that the body digests and metabolises lipids). Male volunteers have been selected as they elicit a higher postprandial lipaemic response to a given fat load and therefore are more sensitive to dietary manipulation.

Power calculation: A sample size of 10 has 80% power to detect a difference between means of 112.74 units in area under the curve in plasma TAG with a significance level (alpha) of 0.05 (two-tailed).

Expected value:

The study will provide novel information on the acute effects of commercially relevant spreads on postprandial lipaemia and satiety. It will also explore possible mechanisms for the predicted reduced lipaemia following the interesterified fat from measurements of gastric emptying.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age: 18-45

2. Male

3. Healthy (free of diagnosed diseases listed in exclusion criteria)

4. Able to understand the information sheet and willing to comply with study protocol

5. Able to give informed consent

Exclusion criteria:

1. Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes

2. Body mass index < 20 kg/m2 or > 35 kg/m2

3. Plasma cholesterol =7.5 mmol/L

4. Plasma triacylglycerol > 3 mmol/L

5. Plasma glucose > 7 mmol/L

6. Blood pressure =160/100 mmHg

7. Current use of antihypertensive or lipid lowering medications

8. Alcohol intake exceeding a moderate intake (> 28 units per week)

9. Current cigarette smoker

10. = 20% 10-year risk of cardiovascular disease as calculated using risk calculator

11. Ingestion of paracetamol in the preceding 24 hrs to study days

Related Conditions & MeSH terms

• Healthy Men

Intervention

Dietary Supplement:
• Interesterified blend of palm kernal and plam stearin
50g fat provided as interesterified palm kernal and palm sterin blend in a single meal
• Un-interesterified blend of palm kernal and plam stearin
50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal

Locations

Country	Name	City	State
United Kingdom	Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satiety (Postprandial visual analogue scales)	Postprandial visual analogue scales	Postprandial 4 hrs
Other	Gastric emptying (Postprandial paracetamol concentrations)	Postprandial paracetamol concentrations	Postprandial 4 hrs
Primary	Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)	Postprandial plasma triacylglycerol concentrations	Postprandial 4 hrs
Secondary	Glycemia (Postprandial plasma glucose and insulin concentrations)	Postprandial plasma glucose and insulin concentrations	Postprandial 4 hrs
Secondary	Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)	Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations	Postprandial 4 hrs