NCT03191513

Brief Summary

The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

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

May 23, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2018

Completed
Last Updated

October 26, 2020

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

May 23, 2017

Last Update Submit

October 22, 2020

Conditions

Healthy AdultsPostmenopausal Women

Keywords

InteresterifiedPostprandialLipid

Outcome Measures

Primary Outcomes (1)

  • Area under plasma TAG concentration/ time curve

    Postprandial area under plasma TAG concentration/ time curve

    Up to 8 hours

Secondary Outcomes (2)

  • Postprandial lipaemic response

    Up to 8 hours

  • Positional composition retention (chylomicron)

    Up to 6 hours

Other Outcomes (3)

  • Isotope lablelled parameters

    Up to 8 hours

  • Lipoprotein particle size and number

    Up to 8 hours

  • 2 and 3 MCPD and glycidyl esters

    Up to 8 hours

Study Arms (3)

Interesterified

EXPERIMENTAL

Interesterified blend of palm kernal and plam stearin. 50g fat.

Dietary Supplement: Interesterified blend of palm kernal and plam stearin

Un-interesterified

ACTIVE COMPARATOR

Un-interesterified blend of palm kernal and plam stearin. 50g fat.

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

Control

ACTIVE COMPARATOR

Rapeseed oil. 50g fat.

Dietary Supplement: Rapeseed oil

Interventions

Interesterified blend of palm kernal and plam stearinDIETARY_SUPPLEMENT

50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

Also known as: Interesterified blend
Interesterified
Un-interesterified blend of palm kernal and plam stearinDIETARY_SUPPLEMENT

50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

Also known as: Un-interesterified blend
Un-interesterified
Rapeseed oilDIETARY_SUPPLEMENT

50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

Also known as: Control fat
Control

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 45-75 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
  • Premenopausal (for women)
  • Alcohol intake exceeding a moderate intake (\> 28 units per week)
  • Current cigarette smoker (or quit withint 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 (1)

King's College London

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • Burnap SA, Sattler K, Pechlaner R, Duregotti E, Lu R, Theofilatos K, Takov K, Heusch G, Tsimikas S, Fernandez-Hernando C, Berry SE, Hall WL, Notdurfter M, Rungger G, Paulweber B, Willeit J, Kiechl S, Levkau B, Mayr M. PCSK9 Activity Is Potentiated Through HDL Binding. Circ Res. 2021 Nov 12;129(11):1039-1053. doi: 10.1161/CIRCRESAHA.121.319272. Epub 2021 Oct 4.

    PMID: 34601896DERIVED

MeSH Terms

Interventions

Rapeseed Oil

Intervention Hierarchy (Ancestors)

Plant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Sarah EE Berry, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

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

May 23, 2017

First Posted

June 19, 2017

Study Start

June 12, 2017

Primary Completion

May 15, 2018

Study Completion

May 27, 2018

Last Updated

October 26, 2020

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)