Overview

This trial is active, not recruiting.

Condition healthy men
Treatments un-interesterified palm kernal and palm stearin, interesterified palm kernal and palm stearin
Sponsor King's College London
Start date February 2015
End date June 2015
Trial size 14 participants
Trial identifier NCT02365987, BDM/14/15-26

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Experimental)
Un-interesterified blend of palm kernal and plam stearin oils
un-interesterified palm kernal and palm stearin un-interesterified palm kernal and palm stearin
50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal
(Experimental)
Interesterified blend of palm kernal and palm stearin oils
interesterified palm kernal and palm stearin interesterified palm kernal and palm stearin
50g fat provided as interesterified palm kernal and palm sterin blend in a single meal

Primary Outcomes

Measure
Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)
time frame: Postprandial 4 hrs

Secondary Outcomes

Measure
Glycemia (Postprandial plasma glucose and insulin concentrations)
time frame: Postprandial 4 hrs
Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)
time frame: Postprandial 4 hrs

Eligibility Criteria

Male participants from 18 years up to 45 years old.

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

Additional Information

Official title The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Lipaemia and Satiety: a Randomised Controlled Trial. The INTER-FAT Study
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by King's College London.