To compare the effects of commercially relevant IE palmitic and stearic acid rich fat blends on fasting and postprandial cardiometabolic risk parameters after chronic exposure to these fats.
ID
Source
Brief title
(Interesterified saturated fatty acids)
Condition
- Other condition
Synonym
Health condition
Metabolisme
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the difference in the total to HDL-cholesterol ratio
as measured at the end of the intervention periods.
Secondary outcome
Secondary endpoints include the postprandial lipidemic and glycaemic effects
after chronic exposure to these fats.
Background summary
Random interesterification is extensively used by the food industry to create
fats with desirable functional characteristics for use in spreads and bakery
products without the use of trans fatty acids (FA) or animal fats and with a
lower saturated FA (SFA) content. Randomly interesterified (IE) fats rich in
palmitic and stearic acids are the most commonly used IE fats by the food
industry. Palmitic-acid rich IE fats are generally used by the European market
and derived from palm fruits and include palm oil fractions such as palm
stearines (PSt) (high in palmitic acid) and, in smaller proportions, palm
kernel oil (PK) or coconut oil (both rich in lauric acid). Stearic-acid rich IE
fats are generally used by the North American market and typically are derived
from fully hydrogenated soybean (FHS) IE with vegetable oils. Despite their
widespread use, there has been no published research on the cardio-metabolic
health effects of the most commonly consumed palmitic and stearic acid rich IE
fats.
Study objective
To compare the effects of commercially relevant IE palmitic and stearic acid
rich fat blends on fasting and postprandial cardiometabolic risk parameters
after chronic exposure to these fats.
Study design
This is a double-blind, randomized, cross-over study with commercially relevant
palmitic and stearic acid rich IE fats. Subjects will receive both fats for 6
weeks with a wash-out period of at least 4 weeks in between. Contrast in the
intakes of the IE fats is 15% of energy. A postprandial test will be carried
out at the start and the end of each dietary period.
Intervention
Following a 2-week run-in period, volunteers will be randomly allocated to test
diets providing 15% energy of the hardstock from test fats (palm stearin kernel
blended with rapeseed oil (PSKb) or a fully hydrogenated rapeseed oil blended
with sunflower oil and coconut oil (FHRpS)) for 6 weeks with a washout period
of at least 4 weeks. A subgroup will undergo postprandial test meal challenges
at the start and end of each 6-week intervention on the corresponding test fat.
Study burden and risks
Before the start of the study, subjects will be screened to determine
eligibility during one 15 min visit. During this visit, body weight, and height
will be measured and a blood sample (7.5 mL) will be drawn by means of
venapunction. Blood pressure will also be measured. Thereafter, subjects will
be asked to fill in a medical and general questionnaire, including information
on physical activity. During the study, subjects will receive products based on
the experimental fats. On 4 occasions a fasting blood sample will be drawn
(with a total of 76 mL spread over the four visits), body weight, fat
distribution (waist to hip ratio), and blood pressure will be measured. At the
start and end of each intervention period, a subgroup will participate in a
postprandial test. An intravenous cannula will be inserted in an antecubital
vein. Before and after meal consumption, 14 blood samples (4x130.5 mL) will be
drawn during an 8-hour period. During the test, subjects are allowed to drink
water and to walk freely around. In this subgroup, liver fat will be assessed
as well at the end of each experimental using magnetic resonance imaging
(MRI). Subjects may visit the research facilities in between to pick up the
experimental products. All subjects will be asked to complete a food frequency
questionnaire four times. Subjects will register daily the intake of the
experimental foods, and the remaining products in a diary, as well as any signs
of illness, medication used, and any deviations from the protocol. On rare
occasions, blood sampling might cause bruises or hematoma. Total time
investment for the subjects will be approximately 16 hours for those who do not
participate in the postprandial tests plus MRI measurements and 55 hours for
those who will participate in the postprandial test.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Apparently healthy men and women
- Non-smoking
- Age: 35-65 yrs
- Having a general practitioner
- Signed informed consent
- Agreeing to be informed about medically relevant personal test-results by a
physician
- For the subgroup (Maastricht only): No contra-indication for MRI measurements
Exclusion criteria
- Having a medical condition which might impact study measurements
- Use of over-the-counter and prescribed medication, which may interfere with
study measurements
- Use of food supplements or plant-sterol/stanol-enriched foods or supplements
in the three months prior to the screening and/or during the study;
- Reported alcohol consumption * 21 units/week;
- Reported weight loss or gain of 3 kg or more during a period of 2 months
prior to screening
- Reported dietary habits: medically prescribed diet, allergy/intolerance to
test products that will be provided during the study
- Blood donation in the past 3 months
- Drug abuse
- Reported participation in another nutritional or biomedical trial 3 months
prior to screening
- Serum lipids: treatment recommended according to the *Multidisciplinaire
richtlijn Cardiovasculair risicomanagement*
- Body mass index < 20 kg/m2 or > 35 kg/m2
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | Na METC goedkeuring wordt het in ClinicalTrials.gov geregistreerd |
CCMO | NL70252.068.19 |