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Trial registered on ANZCTR


Registration number
ACTRN12611000456954
Ethics application status
Approved
Date submitted
29/04/2011
Date registered
4/05/2011
Date last updated
9/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of the type of fat ingested at breakfast on the plasma lipid profile of women at risk of cardiovascular disease
Scientific title
Effect of the type of fat ingested at breakfast on the plasma lipid profile of postmenopausal women at risk of cardiovascular disease
Secondary ID [1] 260073 0
Nil
Universal Trial Number (UTN)
U1111-1121-0635
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the study is conducted in healthy human volunteers: Postmenopausal Women 265750 0
Cardiovascular disease 265756 0
Hypercholesterolemia 265757 0
Condition category
Condition code
Diet and Nutrition 265893 265893 0 0
Other diet and nutrition disorders
Cardiovascular 265904 265904 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We conducted a randomized, crossover and longitudinal study in humans who were randomly assigned to receive during a period of one month each type of breakfast: 3 study periods (breakfast with the same composition [200 ml Semi skimmed milk+ 18 g of soluble coffee ( 1 monodose sachette)+8 g of sugar ( 1 monodose sachette)+ 2 toasts of bread white] plus 20 g of butter/margarine/olive oil in breakfast A/B/C respectively. Each study period is separated by one washout period (45-day). The composition of breakfast in washout period is: 200 ml Semi skimmed milk+ 18 g of soluble coffee ( 1 monodose sachette)+8 g of sugar ( 1 monodose sachette)+ 2 tosts of bread white +50 g of jam of peach + 200 ml of pineapple juice. This was an interventionist, longitudinal, randomized and crossover clinical trial where the participants consume each breakfast daily for a period of one month (30 days). Each participant consume each breakfast daily for a period of one month (30 days).The nutritional composition of breakfast and the other meals of the day was identical for all the volunteers, except the type of fat contributed in the breakfast each month.
Intervention code [1] 264494 0
Prevention
Intervention code [2] 264501 0
Lifestyle
Comparator / control treatment
Comparison of breakfasts A, B and C
Control group
Active

Outcomes
Primary outcome [1] 266657 0
% of participants with statistically significant change in the levels of total cholesterol in plasma. Total cholesterol was measured according to the colorimetric enzymatic method of cholesterol esterase , in which cholesterol esters are hydrolized to free cholesterol.

Analytical determinations: All blood extractions were performed in fasting conditions by puncture of the cubital vein. All the extractions (18 ml) were performed in the same conditions and samples were processed by the same staff (clinical biochemists), following the recommendations of the National for Committee Clinical Laboratory Standars and using the reference values of Roche Diagnostics GmbH.
Timepoint [1] 266657 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Primary outcome [2] 266658 0
biomarkers of cardiovascular risk: BMI, arterial blood pressure and cardiac frecuency. BMI was estimated using the formula from levels of weight and height. Arterial blood pressure and cardiac frecuency were assessed with the automatic sphygmomanometer
Timepoint [2] 266658 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Primary outcome [3] 266670 0
% of participants with statistically significant change in the levels of LDL cholesterol in plasma.LDL cholesterol concentration was estimated using the Friedewald, Levy and Fredrickson formula from levels of HDL cholesterol, total cholesterol and triglycerides (provided that levels of triglycerides is < 200 mg/dl), as follows:
LDL cholesterol (Friedewald) = Total Cholesterol (mg/dl) - HDL cholesterol (mg/dl) - [Triglycerides (mg/dl)/5]
Timepoint [3] 266670 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Secondary outcome [1] 276148 0
% of participants with statistically significant change in the levels of HDL cholesterol in plasma. For quantifying cholesterol in HDL a homogeneous colorimetric enzymatic test was performed, in which dextran sulphate and magnesium ions selectively precipitate the LDL and VLDL fractions, leaving the HDL fraction in solution. HDL cholesterol is then determined photometrically using an enzymatic cholesterol assay (cholesterol esterase).
Timepoint [1] 276148 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Secondary outcome [2] 276149 0
The nutritional valuation of the diet (energy, proteins, lipids, carbohydrates) using an suitable software (Dietsource v.3).
Timepoint [2] 276149 0
During the DAY 5, 15 AND 20 OF EACH MONTH of each period of nutritional intervention (3 x 3 = 9 questionnaires of each participant of the study)
Secondary outcome [3] 276161 0
% of participants with statistically significant change in the levels of Triglycerides in plasma.Triglycerides were measured in accordance with the colorimetric and enzymatic test of lipoprotein lipase, where glycerol set free is converted to glycerol-3phosphate by the action of glycerolkinase and it is oxidated to form hydrogen peroxide. This reacts with 4-aminoantipyrine producing a violet complex whose intensity of colour is proportional to the concentration of triglycerides in the sample.
Timepoint [3] 276161 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Secondary outcome [4] 276162 0
% of participants with statistically significant change in the levels of Subfractions of LDL particles in plasma. The Subfractions of LDL particles in plasma were assessed with Gel electrophoresis technique.
Timepoint [4] 276162 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.
Secondary outcome [5] 276163 0
% of participants with statistically significant change in the Other analytical parameters differents of lipid profile: glucose, total protein, albumin, urea, creatinine, uric acid, enzymes (AST, ALT), ions (Na, K, Cl). The measurements were assessed with autoanalyzer equip.
Timepoint [5] 276163 0
The first and last day of each one of the three periods of breakfasts, in fasting conditions: before and after of the month with breakfast A; before and after of the month with breakfast B; before and after of the month with breakfast C.

Eligibility
Key inclusion criteria
- Postmenopausal women
- Caucasian white women
Minimum age
60 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- volunteers gender male
- women who are not postmenopausal
- women with nutritional rare habits (vegetarians, persons who do not consume lacteal, diets of slimming)
- Women who are disease of absorption of fats
- Women with psychiatric disease

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)
The voluntary ones were obtained from feminine resident associations in Murcia and every voluntary one consumed three types of breakfast according to random order: the person who determined if a subject was eligible for inclusion in the trial was unaware, when this decision was made, to which group the subject would be allocated.Allocation was concealed and it was done by for sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 3433 0
Spain
State/province [1] 3433 0
MURCIA

Funding & Sponsors
Funding source category [1] 264971 0
University
Name [1] 264971 0
UNIVERSIDAD CATOLICA SAN ANTONIO DE MURCIA
Country [1] 264971 0
Spain
Primary sponsor type
Individual
Name
JUANA Ma MORILLAS RUIZ
Address
DPTO. TECNOLOGIA DE LA ALIMENTACION Y NUTRICION
UNIV. CATOLICA SAN ANTONIO DE MURCIA
CAMPUS LOS JERONIMOS S/N
30107- GUADALUPE(MURCIA)
Country
Spain
Secondary sponsor category [1] 264063 0
None
Name [1] 264063 0
Address [1] 264063 0
Country [1] 264063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266932 0
COMITE DE ETICA DE LA UNIVERSIDAD CATOLICA SAN ANTONIO DE MURCIA
Ethics committee address [1] 266932 0
Ethics committee country [1] 266932 0
Spain
Date submitted for ethics approval [1] 266932 0
Approval date [1] 266932 0
25/10/2007
Ethics approval number [1] 266932 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32545 0
Address 32545 0
Country 32545 0
Phone 32545 0
Fax 32545 0
Email 32545 0
Contact person for public queries
Name 15792 0
JUANA Ma MORILLAS RUIZ
Address 15792 0
DPTO. TECNOLOGIA DE LA ALIMENTACION Y NUTRICION. UNIV. CATOLICA SAN ANTONIO. CAMPUS LOS JERONIMOS, 30107. GUADALUPE. MURCIA.
Country 15792 0
Spain
Phone 15792 0
34 968 278753
Fax 15792 0
Email 15792 0
jmmorillas@pdi.ucam.edu
Contact person for scientific queries
Name 6720 0
JUANA Ma MORILLAS RUIZ
Address 6720 0
DPTO. TECNOLOGIA DE LA ALIMENTACION Y NUTRICION. UNIV. CATOLICA SAN ANTONIO. CAMPUS LOS JERONIMOS, 30107. GUADALUPE. MURCIA.
Country 6720 0
Spain
Phone 6720 0
34 968 278753
Fax 6720 0
Email 6720 0
jmmorillas@pdi.ucam.edu

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
No additional documents have been identified.