Condition category
Nutritional, Metabolic, Endocrine
Date applied
02/02/2010
Date assigned
26/02/2010
Last edited
26/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emilio Ros

ORCID ID

Contact details

Hospital Clinic de Barcelona
C/ Villaroel 170
barcelona
08036
Spain
+34 93 2279383
eros@clinic.ub.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

cb0603-feiraco-ul02

Study information

Scientific title

Bioavailability and metabolic effects in humans of n-3 polyunsaturated fatty acids and conjugated linoleic acid after consumption of naturally enriched cow milk: a randomised double blind parallel group trial

Acronym

Study hypothesis

Including linseed in the feed of milk-producing animals provides polyunsaturated fatty acids (PUFA), mainly linoleic and alpha-linoleic acids, which rumen bacteria transform into longer-chain (and more unsaturated) derivatives and cis-9, trans-11 conjugated linoleic acid (CLA) that are incorporated into milk. Both n-3 PUFA and CLA are suggested to have beneficial effects on cardiovascular risk and adiposity, respectively.

Our hypothesis is that, compared to the daily intake during 6 weeks of 500 ml of milk obtained froms cows eating regular feed, intake during 6 weeks of 500 ml of milk from similar cows fed 5% extruded linseed will be associated with an increase of n-3 PUFA and CLA in plasma, thus demonstrating their bioavailability from milk.

Ethics approval

Institutional Review Board of the Hospital Clinic of Barcelona approved on the 7th April 2009 (ref: 2009/4920)

Study design

Randomised double-blind parallel group feeding intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Can be found at http://www.ciberobn.es/media/faq/Oficina%20de%20Proyectos/HOJA%20DE%20INFORMACIÓN%20AL%20PARTICIPANTE%20%20Y%20CI.doc

Condition

Nutrition

Intervention

Experimental group: 500 ml/day of test milk
Control group: 500 ml/day of regular milk

The methodology is the same for participants in the two arms of the study, except for the milk product given (milk naturally enriched in n-3 fatty acids and CLA in one arm, plain milk in the other arm). A requisite for entry is that participants are overweight and do not consume fermented milk products or fatty fish more than once per week. They are instructed to follow their usual diet and physical activity throughout the study, which lasts 6 weeks, and consume 500 ml per day of the corresponding milk, which is provided in 1 litre containers labelled as A or B to mask the composition. On week -1 and week 5 participants fill in 7-day food records, and on days 1 and 42 they undergo medical questionnaires, anthropometric and blood pressure measurements, and venipuncture. Also on day 42 they bring empty milk containers to recount and measure adherence. There is no further follow-up after 6 weeks, but participants are given copies of biochemical analyses and will be given a brief explanation of the results of the study once they become available.

Anthropometry (height, weight and waist circumference) and blood pressure are determined by standard methods. 7-day food records are translated into nutrients by using the Food Processor, Version 8.44 software (ESHA Research, Salem, OR) adapted to nutrient databases of specific Mediterranean foods when appropriate. Blood glucose and lipids are analysed by standard enzymatic methods; safety haematological and biochemical analytes by standard clinical laboratory automated methods; and plasma fatty acids by gas chromatography.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Determination of plasma fatty acid content at baseline and after 6 weeks of consumption of experimental and control milks

Secondary outcome measures

1. Medical record, including anthropometric measurements (height, weight and waist circumference) and blood pressure at baseline and end of treatment
2. Food, energy and nutrient intake assessed by 7-day food records prior to entry and on the last week of intervention
3. Blood chemistry, with safety profile (complete blood count, fasting blood glucose, creatinine, uric acid, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase [GGT], and total protein) and lipid profiles (total cholesterol, high density lipoprotein [HDL] cholesterol, low density lipopotein [LDL] cholesterol and triglycerides) at baseline and the end of treatment

Overall trial start date

01/05/2009

Overall trial end date

31/01/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy men and women volunteers
2. Aged between 18 and 50 years
3. Overweight (body mass index [BMI] between 25.0 and 29.9 kg/m^2)
4. Sign an informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

38

Participant exclusion criteria

1. Subjects with a prior history of cardiovascular disease, cancer, any severe chronic disease, psychiatric condition, alcoholism or drug abuse
2. Milk intolerance
3. Intake of fish oil capsules or fish oil enriched foods in the prior 3 months
4. Consumption of fatty fish more than once per week
5. BMI outside of pre-specified range

Recruitment start date

01/05/2009

Recruitment end date

31/01/2010

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Clinic de Barcelona
barcelona
08036
Spain

Sponsor information

Organisation

Feiraco Lacteos S.L. (Spain)

Sponsor details

Apartado 19
Negreira
A Coruña
15830
Spain

Sponsor type

Industry

Website

http://www.feiraco.es/

Funders

Funder type

Government

Funder name

Feiraco Lacteos S.L. (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Ministry of Science and Innovation (Ministerio de Ciencia e Innovación [MICINN]) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

CIBER fisiopatología de la obesidad y nutrición (CIBERobn) (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Ministry of Health (Spain) - Health Research Fund (Fondo de Investigaciones Sanitarias [FIS]) (ref: cd07/00083)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes