NCT03438084

Brief Summary

The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

January 27, 2020

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

February 13, 2018

Last Update Submit

January 24, 2020

Conditions

Healthy Adults

Keywords

InteresterifiedPostprandialLipid

Outcome Measures

Primary Outcomes (2)

  • Endothelial function

    Flow mediated dilatation

    Up to 8 hours

  • Postprandial lipaemic response

    Area under plasma TAG concentration/ time curve

    Up to 8 hours

Secondary Outcomes (7)

  • Postprandial lipaemic response

    Up to 8 hours

  • Metabolomic for assessment of atherogenic potential (lipoprotein) analysis

    Up to 8 hours

  • Glycaemic response

    Up to 8 hours

  • Insulinaemic response

    Up to 8 hours

  • Nitric oxide bioavailability

    Up to 8 hours

  • +2 more secondary outcomes

Study Arms (4)

Interesterified

EXPERIMENTAL

Commercially available interesterifed fat spread. 50g fat.

Dietary Supplement: Interesterified fat

Non- interesterified

ACTIVE COMPARATOR

Commercially available non-interesterified fat. 50g fat.

Dietary Supplement: Non- interesterified fat

Control

ACTIVE COMPARATOR

Rapeseed oil. 50 g fat.

Dietary Supplement: Rapeseed oil

Saturated fat control

ACTIVE COMPARATOR

Butter. 50g fat

Dietary Supplement: Butter

Interventions

Interesterified fatDIETARY_SUPPLEMENT

50 g fat provided as commercially available interesterified fat.

Interesterified
Non- interesterified fatDIETARY_SUPPLEMENT

50 g fat provided as commercially available non-interesterified fat.

Non- interesterified
Rapeseed oilDIETARY_SUPPLEMENT

50 g fat provided as commercially available rapeseed oil.

Control
ButterDIETARY_SUPPLEMENT

50g fat provided as commercially available spreadable butter

Saturated fat control

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 35-75 years

You may not qualify if:

  • Able to understand the information sheet and willing to comply with study protocol
  • Able to give informed consent
  • 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 ≥140/90 mmHg
  • Current use of antihypertensive or lipid lowering medications
  • Alcohol intake exceeding a moderate intake (\> 28 units per week)
  • Current cigarette smoker (or quit within the last 6 months)
  • ≥ 20% 10-year risk of CVD as calculated using a risk calculator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London

London, SE1 9NH, United Kingdom

Location

King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • Hall WL, Alkoblan A, Gibson PS, D'Annibale M, Coekaerts A, Bauer M, Bruce JH, Lecomte B, Penhoat A, Laugerette F, Michalski MC, Salt LJ, Wilde PJ, Berry SE. Postprandial lipid and vascular responses following consumption of a commercially-relevant interesterified palmitic acid-rich spread in comparison to functionally-equivalent non-interesterified spread and spreadable butter: a randomised controlled trial in healthy adults. Food Funct. 2024 Mar 4;15(5):2733-2750. doi: 10.1039/d3fo05324e.

    PMID: 38380649DERIVED

MeSH Terms

Interventions

Rapeseed OilButter

Intervention Hierarchy (Ancestors)

Plant OilsOilsLipidsPlant PreparationsBiological ProductsComplex MixturesDietary FatsFatsDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 19, 2018

Study Start

July 1, 2018

Primary Completion

October 1, 2019

Study Completion

October 31, 2019

Last Updated

January 27, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)