The InterSat Study

NCT04418102 | Completed

• 1 other identifier: HR-19/20-14655
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

Brief Summary

In response to the removal of trans fats from our foods, the food industry now uses interesterified (IE) fats. Randomly interesterified (IE) fats rich in palmitic (Europe) and stearic (North America) acids are the most commonly used IE fats by the food industry. Despite their widespread use, there has been no published research on the acute and chronic cardio-metabolic health effects of the most commonly consumed palmitic and stearic acid rich IE fats. The aim of InterSat is to investigate the postprandial and chronic effects of a diet rich in IE fats on cardiometabolic health.

Conditions

Cardiometabolic Health

Keywords

Interesterified fat; Cardiometabolic health; Palmitic acid; Stearic acid; Vascular function; Postprandial lipaemia

Outcome Measures

Primary Outcomes (1)

• Change from baseline in fasting total:HDL cholesterol ratio

  Total to high-density lipoprotein (Total:HDL) cholesterol ratio

  6 weeks

Secondary Outcomes (13)

• Postprandial lipaemia

  Fasting, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.

• Endothelial function

  Fasting, 270 min and 450 min following consumption of breakfast containing IE fats

• Postprandial glucose homeostasis (Incremental area under the curve (iAUC) 0-240 min and 0-480 min)

  Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.

• Fasting Insulin sensitivity

  Fasting, 30 min, 60 min, 120 min, 180 min, 240 min, 300 min, 360 min, 420 min, 480 min following consumption of breakfast containing IE fats.

• Change from baseline in liver fat (Maastricht only)

  6 weeks

Study Arms (2)

Palmitic acid rich interesterified fat

EXPERIMENTAL

Snacks (muffins) and spread containing palmitic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.

Dietary Supplement: Palmitic acid rich interesterified fat

Stearic acid rich interesterified fat

ACTIVE COMPARATOR

Snacks (muffins) and spread containing stearic acid rich interesterified fat to replace habitual snacks and spreads, and provide 10% of total daily energy intake with the interesterified fat.

Dietary Supplement: Stearic acid rich interesterified fat

Interventions

Palmitic acid rich interesterified fat DIETARY_SUPPLEMENT

Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period

Palmitic acid rich interesterified fat

Stearic acid rich interesterified fat DIETARY_SUPPLEMENT

Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period.

Stearic acid rich interesterified fat

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Able to give informed consent.
• Able to give informed consent.
• Accessible veins on arms as determined by examination at screening
• Having a medical condition or history which might impact study measurements, to be judged by the study physician (e.g. myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes)
• Use of plant-sterol/stanol-enriched foods or supplements in the three months prior to the screening and/or during the study
• 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
• Full blood count (FBC), liver function out of healthy range
• Blood pressure ≥140/90 mmHg
• Current use of antihypertensive or lipid lowering medications
• Use of over-the-counter and prescribed medication, which may interfere with study measurements (to be judged by the principal investigator)
• Alcohol intake exceeding a moderate intake (\> 21 units per week)
• Current cigarette smoker (or quit within last 6 months)

Sponsors & Collaborators

• King's College London: lead
• Maastricht University: collaborator

Study Sites (2)

Maastricht University

Maastricht, 616 6200, Netherlands

Location

Department of Nutritional Sciences, King's College London. Franklin-Wilkins Buiding. Waterloo Campus

London, England, SE1 9NH, United Kingdom

Location

Related Publications (1)

• Hall WL, Wood E, Joris PJ, Smith HA, Creedon A, Maher T, Bruce JH, Mensink RP, Berry SE. The effects of consumption of interesterified fats rich in palmitic acid compared with stearic acid on intermediary markers of cardiometabolic disease risk: a randomized controlled trial in healthy adults. Am J Clin Nutr. 2025 Nov;122(5):1361-1373. doi: 10.1016/j.ajcnut.2025.09.025. Epub 2025 Sep 18.

  PMID: 40975239 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial with 2x6 week interventions separated by a 3 week washout.

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: June 5, 2020
• Study Start: February 1, 2020
• Primary Completion: August 25, 2022
• Study Completion: August 25, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); GB (1)