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

K

King's College London

Status

Completed

Conditions

Healthy Men

Treatments

Dietary Supplement: Interesterified blend of palm kernal and plam stearin
Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin

Study type

Interventional

Funder types

Other

Identifiers

NCT02365987
BDM/14/15-26

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

12 participants in 2 patient groups

Interesterified
Experimental group
Description:
Interesterified blend of palm kernal and plam stearin. 50g fat.
Treatment:
Dietary Supplement: Interesterified blend of palm kernal and plam stearin
Un-interesterified
Active Comparator group
Description:
Un-interesterified blend of palm kernal and plam stearin. 50g fat.
Treatment:
Dietary Supplement: Un-interesterified blend of palm kernal and plam stearin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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