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Completed

NCT Number: NCT02365987

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

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes and Nutritional Sciences Division, School of Medicine, Kings College London, London, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18-45
  • Male
  • Healthy (free of diagnosed diseases listed in exclusion criteria)
  • Able to understand the information sheet and willing to comply with study protocol
  • Able to give informed consent

Exclusion criteria

  • Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
  • Body mass index < 20 kg/m2 or > 35 kg/m2
  • Plasma cholesterol ≥7.5 mmol/L
  • Plasma triacylglycerol > 3 mmol/L
  • Plasma glucose > 7 mmol/L
  • Blood pressure ≥160/100 mmHg
  • Current use of antihypertensive or lipid lowering medications
  • Alcohol intake exceeding a moderate intake (> 28 units per week)
  • Current cigarette smoker
  • ≥ 20% 10-year risk of cardiovascular disease as calculated using risk calculator
  • Ingestion of paracetamol in the preceding 24 hrs to study days

Treatment and study plan

Interesterified blend of palm kernal and plam stearin

Dietary Supplement

50g fat provided as interesterified palm kernal and palm sterin blend in a single meal

Other names: Interesterified blend

Un-interesterified blend of palm kernal and plam stearin

Dietary Supplement

50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal

Other names: Un-interesterified blend

Primary outcomes

  1. Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)

    Time frame: Postprandial 4 hrs

    Postprandial plasma triacylglycerol concentrations

Secondary outcomes

  1. Glycemia (Postprandial plasma glucose and insulin concentrations)

    Time frame: Postprandial 4 hrs

    Postprandial plasma glucose and insulin concentrations

  2. Gut hormones (Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations)

    Time frame: Postprandial 4 hrs

    Postprandial gut peptide YY and glucose-dependent insulinotropic polypeptide concentrations

Other outcomes

  1. Satiety (Postprandial visual analogue scales)

    Time frame: Postprandial 4 hrs

    Postprandial visual analogue scales

  2. Gastric emptying (Postprandial paracetamol concentrations)

    Time frame: Postprandial 4 hrs

    Postprandial paracetamol concentrations

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

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

Acronym: INTERFAT

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2015
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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