Condition category
Nutritional, Metabolic, Endocrine
Date applied
08/01/2020
Date assigned
13/01/2020
Last edited
10/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
We know that poor lifestyles, including the food we eat, can increase the risk of developing cardiovascular disease. One area of research that has received little attention, is whether changing the amount and structure of fat in food can influence cardiovascular disease risk factors. This study assesses whether changing the amount and structure of fat in food can influence a range of cardiovascular risk factors, including the presentation of fat in the blood. High amounts of fat in the blood has been shown to increase the risk of cardiovascular disease. The study is being carried out by researchers from the School of Food Science and Nutrition and the Leeds Institute of Genetics, Health and Therapeutics at the University of Leeds.

Who can participate?
Healthy adults aged 18 to 70 years.

What does the study involve?
Participants will be assessed for eligibility against set criteria. This will involve asking questions about lifestyle, age, medical issues any treatment or medication.

After confirming eligibility, participants will attend three laboratory visits commencing on a morning-time (between 08:00 and 09:00 AM), with each visit separated by at least 3 days.

During the course of 24-hours prior to the first visit to the laboratory, participants will record diet and physical activity patterns by logging information into an online programme. Participants will list individual food items consumed during this time and describe items in as much detail as possible (i.e. the size of the portion, time of eating, cooking methods), retaining packaging and nutritional information where possible. During this time, participants will be required to abstain from drinking alcohol, caffeinated drinks and foods, paracetamol and drugs containing paracetamol, as well as strenuous physical activity. Participants will also be provided with a meal, which will serve as their evening, and last, meal of that day. This meal will be comprised of a vegetarian pasta dish with a side of green vegetables. Participants will be required to follow the cooking instructions on the packaging of these foods and note down the time at which they eat them. After they have eaten this meal, participants will abstain from eating or drinking anything else other than water for the remainder of the night. Participants will be asked to replicate eating patterns (the type, amount and timing of food) and physical activity before each visit to the laboratory.

On each visit to the laboratory, participants will be required to arrive in a fasted state; i.e. having not consumed anything other than water after their evening meal and having skipped breakfast. Once participants have arrived at the laboratory, measurements such as height and weight, and blood pressure will be taken. After these measures have been taken, participants will assume a seated position whilst a small cannula is inserted into an arm on the reverse of the elbow. Once an initial blood sample has been taken, participants will consume a meal. The meal will be a curry-based dish served with rice. The meals consumed on each visit to the laboratory will look and taste identical, but will differ in the amount of fat, and the structure of fat, such that on each occasion participants will eat a meal which is either:
1. Low in fat
2. High in fat
3. High in fat (differing in fat structure)

Participants will consume the meal within a 20-minute period. Further blood samples will be taken at regular 30-minute intervals for up to 4-hours. The total number of samples taken will be 9, and the total amount of blood taken across the duration of each visit will be 135ml which is equivalent to approximately one third of a soft drinks can. After the last blood sample has been taken, the cannula will be removed and the participant will be free to leave to the laboratory. Each of the three visits will be identical in procedures (i.e. timing, blood sampling), and differing only in the composition of the food eaten.

What are the possible benefits and risks of participating?
By participating in this study participants will be contributing to internationally leading research on the understanding of cardiovascular risk. We cannot promise that the study will definitely help those who participate, but their results, and the results from other participants may help to provide a better understanding of how the amount and structure of fat in meals can impact the health of the heart and blood vessels.

We will ask participants to complete an initial screening telephone interview to establish whether the study procedures pose any risk to their health. However, as with all research, there are always some potential risks participants should be aware of.

Taking blood from a vein can sometimes cause discomfort and may result in some minor bruising and soreness. All blood samples will be taken by a trained and experienced phlebotomist to ensure safety and minimise discomfort. Participants will be invited into the study only if they satisfy all of the study safety eligibility criteria. As we are using commercially available food products and preparing food items in our controlled nutritional kitchen, we do not anticipate any adverse effects to eating the foods provided.

Where is the study run from?
School of Food Science and Nutrition at the University of Leeds

When is the study starting and how long is it expected to run for?
Recruitment to the study began 12/06/2019 and will run until 10/11/2019.

Who is funding the study?
University of Leeds, Zhejiang Gongshang University, Nutricia Research Foundation, Wellcome Trust and Biotechnology and Biological Sciences Research Council have all contributed to funding for this study.

Who is the main contact?
Dr Matthew Campbell, School of Food Science and Nutrition, University of Leeds m.d.campbell@leeds.ac.uk


Trial website

Contact information

Type

Scientific

Primary contact

Dr Matthew Campbell

ORCID ID

http://orcid.org/0000-0001-5883-5041

Contact details

School of Food Science and Nutrition
University of Leeds
Leeds
LS14 1DB
United Kingdom
+44 (0)113 343 3660
m.d.campbell@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEEC 18-039

Study information

Scientific title

Impact of manipulating lipid droplet size of high-fat meals on postprandial clinical parameters

Acronym

Study hypothesis

Manipulation of the lipid-droplet size will differentially impact postprandial parameters of cardiometabolic health. Configuration to a fine/small lipid droplet size will result in a more pronounced postprandial lipaemic response.

Ethics approval

Approved 11/07/2019, MaPS and Engineering joint Faculty Research Ethics Committee (The Secretariat University of Leeds, Leeds, LS2 9JT; +44 01133431642; MEECResearchEthics@leeds.ac.uk), ref: MEEC 18-039

Study design

Single centre, randomised, interventional trial. Double-blind, cross-over, counter-balanced design.

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Lipid metabolism

Intervention

Randomisation process was via an online computer programme into 3 intervention arms.
3 oral lipid tolerance tests, with each differing in the amount of fat, or fat structure.
Treatment 1: Consumption of a mixed-macronutrient meal with a low-fat content.
Treatment 2: Consumptions of a mixed-macronutrient meal with a high-fat content with large/corse lipid droplet size/composition.
Treatment 3: Consumptions of a mixed-macronutrient meal with a high-fat content with small/fine lipid droplet size/composition.
Total duration of each interventional arm was 48-hours repeated weekly over a 3-week period without further follow-up.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Response to oral fat intake measured by blood triglyceride incremental Area Under the Curve (iAUC) from 0 to 360 minutes postprandially.

Secondary outcome measures

Changes in cardiometabolic parameters (Platelet function and reactivity, cholesterol, lipoprotein and lipoprotein subclasses, and insulin) in response to oral fat intake measured by in whole blood and blood plasma via flow cytometry, an enzymatic method, ELISA, radioimmunoassay assessed from 0 to 360 minutes postprandially.

Overall trial start date

01/02/2019

Overall trial end date

11/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 18-70 years
2. Understanding of written English and ability to provide written informed consent

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

18

Participant exclusion criteria

1. Diagnosis, or current treatment, for issues relating to gut mobility or digestion
2. Diagnosis, or current treatment, for a haematological disorder
3. History of deep vein thrombosis
4. Heart attack or stroke ≤6 months prior to recruitment.
5. History of, or current, malignancy.
6. Pregnancy
7. Amenorrhoea or menopause
8. Allergies or dietary intolerances likely to be exacerbated by study procedures.
9. Medical or psychiatric conditions likely to interfere with the study, as determined by the study investigator

Recruitment start date

12/06/2019

Recruitment end date

10/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
School of Food Science and Nutrition University of Leeds
Leeds
LS14 1DB
United Kingdom

Sponsor information

Organisation

University of Leeds

Sponsor details

The Secretariat
University of Leeds
Leeds
LS14 1DB
United Kingdom
+44 (0)113 343 1642
MEECResearchEthics@leeds.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Leeds

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Universities (academic only)

Location

United Kingdom

Funder name

Zhejiang Gongshang University

Alternative name(s)

ZJSU

Funding Body Type

government organisation

Funding Body Subtype

Universities (academic only)

Location

China

Funder name

Nutricia Research Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

Netherlands

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

United Kingdom

Funder name

Biotechnology and Biological Sciences Research Council

Alternative name(s)

BBSRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Data will be composed and presented for dissemination and publication at scientific meetings and peer-reviewed journals in 2020.
IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/04/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/01/2020: Trial’s existence confirmed by: MaPS and Engineering joint Faculty Research Ethics Committee.