NCT02365987

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

February 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

February 11, 2015

Last Update Submit

March 7, 2017

Conditions

Healthy Men

Keywords

interesterifiedpostprandial

Outcome Measures

Primary Outcomes (1)

  • Postprandial lipaemia (Postprandial plasma triacylglycerol concentrations)

    Postprandial plasma triacylglycerol concentrations

    Postprandial 4 hrs

Secondary Outcomes (2)

  • Glycemia (Postprandial plasma glucose and insulin concentrations)

    Postprandial 4 hrs

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

    Postprandial 4 hrs

Other Outcomes (2)

  • Satiety (Postprandial visual analogue scales)

    Postprandial 4 hrs

  • Gastric emptying (Postprandial paracetamol concentrations)

    Postprandial 4 hrs

Study Arms (2)

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

Interventions

Interesterified blend of palm kernal and plam stearinDIETARY_SUPPLEMENT

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

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

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

Also known as: Un-interesterified blend
Un-interesterified

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-45
  • Male

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 ≥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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

London, London, SE1 9NH, United Kingdom

Location

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

London, SE1 9NH, United Kingdom

Location

Related Publications (1)

  • Hall WL, Iqbal S, Li H, Gray R, Berry SEE. Modulation of postprandial lipaemia by a single meal containing a commonly consumed interesterified palmitic acid-rich fat blend compared to a non-interesterified equivalent. Eur J Nutr. 2017 Dec;56(8):2487-2495. doi: 10.1007/s00394-016-1284-z. Epub 2016 Aug 10.

    PMID: 27511058DERIVED

Study Officials

  • Sarah EE Berry, BSc,MSc,PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Nutritional Sciences

Study Record Dates

First Submitted

February 11, 2015

First Posted

February 19, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)