ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000903381

Ethics application status

Approved

Date submitted

15/06/2017

Date registered

20/06/2017

Date last updated

20/06/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Differential effect of single saturated fat feeding interventional trial in on blood triglycerides in healthy individuals.

Scientific title

Differential effects of short, medium and long chain saturated fatty acids on cardiovascular disease risk factors in healthy adults,

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1197-6328

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular disease

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Short chain fatty acid (butter 40 gram ), medium chain fats (coconut 40 gram ) and long chain fats (lard 40 gram ). Test food will be delivered in the form of biscuits. Biscuits will be made using wholemeal flour, cornflour, icing sugar and 40 gram lard or coconut or butter. Different flavours like orange, lemon and vanilla will be used to prepare biscuits. Participants should consume 6 biscuits (40gram fats) within 15 minutes in front of study staff. Participants will stay in the research area for at least 6-7 hours. All participants will participate for consuming 3 test food with a week wash out period.

Intervention code [1]

Prevention

Comparator / control treatment

We are comparing between three fatty acids: short chain fatty acid (butter), medium chain fatty acids (coconut oil) and long chain fatty acids (lard).

Control group

Active

Outcomes

Primary outcome [1]

Objective: To compare the differential postprandial effect of short, medium and long chain saturated fats on triglyceride levels.
Primary outcome: Triglyceride
Blood (approximately 440 µL) will be collected from the subject's middle and ring finger in the non-dominant hand using capillary collection tubes before and after 2, 3, 4 and 6 hour of test food consumption. Blood samples will be assessed for blood lipid profiles (total cholesterol, high density lipoprotein cholesterol and triglycerides) using Cardio Check PA (PTS).

Timepoint [1]

Baseline and after 2, 3, 4 and 6 hour of test food consumption.

Secondary outcome [1]

Blood samples will be assessed for low density lipoprotein cholesterol (LDL-C) using Cardio Check PA (PTS).

Timepoint [1]

Baseline and after 2, 3, 4 and 6 hour of test food consumption.

Secondary outcome [2]

Blood samples will be assessed for high density lipoprotein cholesterol (HDL-C) using Cardio Check PA (PTS).

Timepoint [2]

Baseline and after 2, 3, 4 and 6 hour of test food consumption.

Secondary outcome [3]

Blood samples will be assessed for total cholesterol (TC) using Cardio Check PA (PTS).

Timepoint [3]

Baseline and after 2, 3, 4 and 6 hour of test food consumption.

Eligibility

Key inclusion criteria

Aged 18-65 years, healthy males or females with Body mass index (BMI) between 18 and 25Kg/m2

Minimum age

18 Years

Maximum age

64 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Have BMI >25 Kg/m2;
• Are pregnant or breast feeding;
• Take any lipid lowering drugs (eg. statins or supplements (e.g. fish oil), or non-steroidal anti-inflammatory drugs (NSAIDs), or anti-hypertensive drugs, or vasodilators, or antioxidants vitamins.
• Are dieting or have any eating disorders;
• Have sensitivity or intolerance to any of the food products or ingredients used in the study;
• Have history of congestive heart failure, stroke, myocardial infarction, coronary artery bypass graft, or atherosclerotic CVD; or pulmonary disease
• Have history of diabetes, hypertension, triglycerides higher than 3.0 mmol/L; total cholesterol higher than 5.5 mmol/L;
• Have history of gastrointestinal disorder, gall bladder disease, or liver disease;
• Taking any dietary supplements that influence blood lipid profile or inflammation;
• Smoke;
• Vegetarian or vegans

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Based on the anticipated 30% difference in primary outcome, iAUC for postprandial triglyceride levels, at the 0.05 level of significance, 80% power, standard deviation of 114 in iAUC. and 10% dropout rate, n=15 subjects will be required for the cross over design.

The effect of test foods on blood lipids and glucose will be determined by using repeated measure ANOVA with post hoc comparisons (Tukey’s honestly significant difference). Baseline data will be used as covariates and changes from the baselines will be determined using paired t-test. Data will be presented as mean ± standard deviation (SD) or median and interquartile range (IQR) as appropriate, a p-value = 0.05 will be considered significant.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

24/06/2017

Actual

Date of last participant enrolment

Anticipated

13/09/2017

Actual

Date of last data collection

Anticipated

13/09/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Newcastle

Address [1]

University Drive
Callaghan NSW 2308

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Newcastle Human Research Ethics Committee,

Ethics committee address [1]

University Drive
Callaghan NSW 2308
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/12/2016

Approval date [1]

23/03/2017

Ethics approval number [1]

H-2016-0429

Summary

Brief summary

In both scientific and public domain, dietary saturated fatty acids (SFAs) are linked with adverse health effects. However, epidemiological and interventional studies have produced contradictory results. Although negative views about SFAs have prevailed, there is increasing evidence to suggest that SFAs are not as harmful as they appear to be and may not be the prime cause of elevated blood lipid levels. Some studies have shown that SFAs induce beneficial effects on blood lipid profiles and that not all SFAs have the same effect on cardiovascular health. SFAs are classified as short (SCFA), medium (MCFA) and long (LCFA) chain fatty acids. SCFA range between 2 to 4 carbons atoms and are found in milk and dairy products. MCFA contain 6 to 12 carbons atoms and are found in coconut oil, palm kernel oil and citrus seeds. LCFA are 14 or more carbons long and are found in animal products like lard, tallow and suet. The digestion, absorbtion and metabolism of fatty acid depends on their chain length. SCFA and MCFA are easily broken down and undergo rapid beta-oxidation for energy production. However LCFA are not easily digested and are deposited in the peripheral tissues. Thus it is convincing to suggest that consumption of SCFA and MCFA, because of their unique structural, absorption and metabolic characteristics can lower blood fat levels and result in less accumulation of fat in the adipose tissues. Evidence from pre-clinical studies have demonstrated that short and medium chain fatty acids do not contribute to obesity, improves blood lipid profiles and other cardiovascular risk factors. If the same is true for humans, naturally occurring SCFA and MCFA intake might help prevent cardiovascular and other chronic diseases. Thus, we hypothesize that short chain saturated fats (butter), medium chain saturated fats (coconut oil) may not be hyperlipidemic as long chain saturated fats (lard).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Manohar Garg

Address

Nutraceuticals Research Program
School of Biomedical Sciences & Pharmacy
Callaghan NSW 2308
University of Newcastle

Country

Australia

Phone

+61-2- 4921 5647

Fax

+61-2-4921 2028

[email protected]

Contact person for public queries

Name

Mrs Nisha Panth

Address

Level 3, Medical Sciences Building
University Drive
Callaghan NSW 2308
University of NewCastle

Country

Australia

Phone

+61249215638

Fax

+61-2-4921 2028

[email protected]

Contact person for scientific queries

Name

Mrs Nisha Panth

Address

Level 3, Medical Sciences Building
University Drive
Callaghan NSW 2308
University of Newcastle

Country

Australia

Phone

+61249215638

Fax

+61-2-4921 2028

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Medium-chain fatty acids lower postprandial lipemia: A randomized crossover trial.	2020	https://dx.doi.org/10.1016/j.clnu.2019.02.008

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically